Clinical trial comparing the homodynamic changes in two methods of complete intravenous and inhalation anesthetics in patients candidate for laparoscopy peritoneal catheterization
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Protocol summary
Objectives: The aim of the present study is to evaluate the hemodynamic changes in two methods of complete intravenous and inhalation anesthesia in renal transplant patients with peritoneal catheterization with laparoscopy.
Design: Randomized clinical trial.
Setting and conduct: Seventy patients were randomly assigned into two groups of complete anesthesia and inhalation anesthesia using random block method.
In the anesthetic inhalation group, for induction, sodium thiopental 4 mg/kg used. Isoflurane 1-2.1% used for maintenance anesthesia.
In the complete intravenous anesthetic group, for induction, Etomidate 3.0 mg/kg is used. For maintenance of anesthesia, Etomidate 100 mg/kg for the first 10 minutes after induction and followed by 20 mg/kg for up to 10 minutes until the end of the surgery used.
In both groups, the hemodynamic changes reported at the first visit to the operating room, after the induction, after intubation, before the injection into the abdominal cavity, after the injection of the gas into the abdominal cavity and then in the recovery room.
The population studied: Renal patients who are candidates for peritoneal catheterization with a laparoscope.
Inclusion criteria: Age between 18 to 80 years; ASA class I and II exclusion criteria: Complications during or after laparoscopic surgery
Interventions: The intervention group is anesthetic inhalation and in the control group, a complete intravenous anesthetic is used.
Main outcome measures (variables): Hemodynamic changes include systolic and diastolic blood pressure, arterial blood pressure and heart rate.
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Objectives: The aim of the present study is to evaluate the hemodynamic changes in two methods of complete intravenous and inhalation anesthesia in renal transplant patients with peritoneal catheterization with laparoscopy. Design: Randomized clinical trial. Setting and conduct: Seventy patients were randomly assigned into two groups of complete anesthesia and inhalation anesthesia using random block method. In the anesthetic inhalation group, for induction, sodium thiopental 4 mg/kg used. Isoflurane 1-2.1% used for maintenance anesthesia. In the complete intravenous anesthetic group, for induction, Etomidate 3.0 mg/kg is used. For maintenance of anesthesia, Etomidate 100 mg/kg for the first 10 minutes after induction and followed by 20 mg/kg for up to 10 minutes until the end of the surgery used. In both groups, the hemodynamic changes reported at the first visit to the operating room, after the induction, after intubation, before the injection into the abdominal cavity, after the injection of the gas into the abdominal cavity and then in the recovery room. The population studied: Renal patients who are candidates for peritoneal catheterization with a laparoscope. Inclusion criteria: Age between 18 to 80 years; ASA class I and II exclusion criteria: Complications during or after laparoscopic surgery Interventions: The intervention group is anesthetic inhalation and in the control group, a complete intravenous anesthetic is used. Main outcome measures (variables): Hemodynamic changes include systolic and diastolic blood pressure, arterial blood pressure and heart rate.
هدف مطالعه: بررسی تغييرات هموديناميک در دو روش بيهوشی کامل داخل وريدی و استنشاقی در بيماران کلیوی کانديد کاتتر گذاری صفاقی با لاپاروسکوپ
طراحی: کارآزمایی بالینی تصادفی
نحوه انجام: 72 بیمار به طور تصادفی با استفاده از بلوک تصادفی 4 تایی در دو گروه بيهوشی کامل داخل وريدی و بيهوشی استنشاقی قرار میگیرند.
در گروه بيهوشی استنشاقی برای اينداکشن از تيوپنتال سديم 4ميلی گرم/کيلوگرم و برای حفظ بيهوشی از هوشبر استنشاقی ايزوفلوران 1-2.1 درصد استفاده ميشود.
در گروه بيهوشی کامل داخل وريدی برای اينداکشن از اتوميديت 3.0 ميلی گرم/کيلوگرم و برای حفظ اتوميديت با دوز 100 ميکروگرم/کيلوگرم برای 10 دقيقه اول بعد از اينداکشن و بعد 20 ماکروگرم/کيلوگرم تا 10 دقيقه مانده به پايان عمل جراحی استفاده ميشود.
در هر دو گروه تغییرات هموداینامیک در بدو مراجعه به اتاق عمل، پس ازاينداکشن، پس از اينتوباسيون، قبل از تزريق گاز در حفره شکم، پس از تزريق گاز در حفره شکم و سپس در ريکاوری ثبت ميشود.
جمعیت مورد مطالعه: بیماران کلیوی که کانديد کاتتر گذاری صفاقی با لاپاروسکوپ قرار می گیرند.
معیارهای ورود: محدوده سنی بین 70-30 سال؛ ASA کلاس I و II معیارهای خروج: عوارض حین یا بعد از عمل جراحی لاپارسکوپی
مداخلات: گروه مداخله از هوشبر استنشاقی و در گروه شاهد بيهوشی کامل داخل وريدی استفاده می شود.
متغیرهای پیامد اصلی: تغييرات هموديناميک شامل فشار خون سيستوليک و دياستوليک، فشار خون متوسط شريانی و تعداد ضربان قلب
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هدف مطالعه: بررسی تغييرات هموديناميک در دو روش بيهوشی کامل داخل وريدی و استنشاقی در بيماران کلیوی کانديد کاتتر گذاری صفاقی با لاپاروسکوپ طراحی: کارآزمایی بالینی تصادفی نحوه انجام: 72 بیمار به طور تصادفی با استفاده از بلوک تصادفی 4 تایی در دو گروه بيهوشی کامل داخل وريدی و بيهوشی استنشاقی قرار میگیرند. در گروه بيهوشی استنشاقی برای اينداکشن از تيوپنتال سديم 4ميلی گرم/کيلوگرم و برای حفظ بيهوشی از هوشبر استنشاقی ايزوفلوران 1-2.1 درصد استفاده ميشود. در گروه بيهوشی کامل داخل وريدی برای اينداکشن از اتوميديت 3.0 ميلی گرم/کيلوگرم و برای حفظ اتوميديت با دوز 100 ميکروگرم/کيلوگرم برای 10 دقيقه اول بعد از اينداکشن و بعد 20 ماکروگرم/کيلوگرم تا 10 دقيقه مانده به پايان عمل جراحی استفاده ميشود. در هر دو گروه تغییرات هموداینامیک در بدو مراجعه به اتاق عمل، پس ازاينداکشن، پس از اينتوباسيون، قبل از تزريق گاز در حفره شکم، پس از تزريق گاز در حفره شکم و سپس در ريکاوری ثبت ميشود. جمعیت مورد مطالعه: بیماران کلیوی که کانديد کاتتر گذاری صفاقی با لاپاروسکوپ قرار می گیرند. معیارهای ورود: محدوده سنی بین 70-30 سال؛ ASA کلاس I و II معیارهای خروج: عوارض حین یا بعد از عمل جراحی لاپارسکوپی مداخلات: گروه مداخله از هوشبر استنشاقی و در گروه شاهد بيهوشی کامل داخل وريدی استفاده می شود. متغیرهای پیامد اصلی: تغييرات هموديناميک شامل فشار خون سيستوليک و دياستوليک، فشار خون متوسط شريانی و تعداد ضربان قلب
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Evaluate the hemodynamic changes in two methods of complete intravenous and inhalation anesthesia in patients candidate for laparoscopy peritoneal catheterization
Evaluate the hemodynamic changes in two methods of complete intravenous and inhalation anesthesia in patients candidate for laparoscopy peritoneal catheterization
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بررسی تغييرات هموديناميک در دو روش بيهوشی کامل داخل وريدی و استنشاقی در بيماران کلیوی کانديد کاتتر گذاری صفاقی با لاپاروسکوپ
بررسی تغييرات هموديناميک در دو روش بيهوشی کامل داخل وريدی و استنشاقی در بيماران کلیوی کانديد کاتتر گذاری صفاقی با لاپاروسکوپ
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Intervention 1: In the anesthetic inhalation group, for induction, sodium thiopental 4 mg/kg used. Isoflurane 1-2.1% used for maintenance anesthesia.
Intervention 2: In the complete intravenous anesthetic group, for induction, Etomidate 3.0 µg/kg is used. For maintenance of anesthesia, Etomidate 100 µg/kg for the first 10 minutes after induction and followed by 20 µg/kg for up to 10 minutes until the end of the surgery used. Clinical trial phase: 3.
Intervention 1: In the anesthetic inhalation group, for induction, sodium thiopental 4 mg/kg used. Isoflurane 1-2.1% used for maintenance anesthesia. Intervention 2: In the complete intravenous anesthetic group, for induction, Etomidate 3.0 µg/kg is used. For maintenance of anesthesia, Etomidate 100 µg/kg for the first 10 minutes after induction and followed by 20 µg/kg for up to 10 minutes until the end of the surgery used. Clinical trial phase: 3.
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72 بیمار به طور تصادفی با استفاده از بلوک تصادفی 4 تایی در دو گروه بيهوشی کامل داخل وريدی و بيهوشی استنشاقی قرار میگیرند.
مداخله 1: در گروه بيهوشی استنشاقی برای اينداکشن از تيوپنتال سديم 4 ميلی گرم/کيلوگرم و برای حفظ بيهوشی از هوشبر استنشاقی ايزوفلوران 1-2.1 درصد استفاده مي شود.
در گروه بيهوشی کامل داخل وريدی برای اينداکشن از اتوميديت 3.0 ماکروگرم/کيلوگرم و برای حفظ اتوميديت با دوز 100 ماکروگرم/کيلوگرم برای 10 دقيقه اول بعد از اينداکشن و بعد 20 ماکروگرم/کيلوگرم تا 10 دقيقه مانده به پايان عمل جراحی استفاده ميشود.
72 بیمار به طور تصادفی با استفاده از بلوک تصادفی 4 تایی در دو گروه بيهوشی کامل داخل وريدی و بيهوشی استنشاقی قرار میگیرند. مداخله 1: در گروه بيهوشی استنشاقی برای اينداکشن از تيوپنتال سديم 4 ميلی گرم/کيلوگرم و برای حفظ بيهوشی از هوشبر استنشاقی ايزوفلوران 1-2.1 درصد استفاده مي شود. در گروه بيهوشی کامل داخل وريدی برای اينداکشن از اتوميديت 3.0 ماکروگرم/کيلوگرم و برای حفظ اتوميديت با دوز 100 ماکروگرم/کيلوگرم برای 10 دقيقه اول بعد از اينداکشن و بعد 20 ماکروگرم/کيلوگرم تا 10 دقيقه مانده به پايان عمل جراحی استفاده ميشود.
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The aim of the study is to evaluate the hemodynamic changes in two methods of complete intravenous and inhalation anesthesia in patients candidate for laparoscopy peritoneal catheterization
The study conducted in the Emam Khomeini hospital of Tehran city.
Seventy patients were randomly assigned into two groups of complete anesthesia and inhalation anesthesia using random block method.
In this study, the patients, measuring the outcomes of study participants (researchers) or Data Monitoring Committee (analyzers) of the patients unaware of intervention.
The aim of the study is to evaluate the hemodynamic changes in two methods of complete intravenous and inhalation anesthesia in patients candidate for laparoscopy peritoneal catheterization The study conducted in the Emam Khomeini hospital of Tehran city. Seventy patients were randomly assigned into two groups of complete anesthesia and inhalation anesthesia using random block method. In this study, the patients, measuring the outcomes of study participants (researchers) or Data Monitoring Committee (analyzers) of the patients unaware of intervention.
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هدف این مطالعه بررسی تغييرات هموديناميک در دو روش بيهوشی کامل داخل وريدی و استنشاقی در بيماران کلیوی کانديد کاتتر گذاری صفاقی با لاپاروسکوپ است.
این مطالعه در بیمارستان امام خمینی شهر تهران انجام می شود.
72 بیمار به طور تصادفی با استفاده از بلوک تصادفی 4 تایی در دو گروه بيهوشی کامل داخل وريدی و بيهوشی استنشاقی قرار میگیرند. این مطالعه به صورت کارازمایی بالینی سه سو کور به این صورت که بیماران، اندازه گیری کنندگان پیامدهای مطالعه (پژوهشگران) و یا کمیته پایش اطلاعات (تحلیل کنندگان) از این که بیماران چه مداخله ای را دریافت نموده اند ناآگاه هستند. فاز کارآزمایی بالینی 3 هست.
هدف این مطالعه بررسی تغييرات هموديناميک در دو روش بيهوشی کامل داخل وريدی و استنشاقی در بيماران کلیوی کانديد کاتتر گذاری صفاقی با لاپاروسکوپ است. این مطالعه در بیمارستان امام خمینی شهر تهران انجام می شود. 72 بیمار به طور تصادفی با استفاده از بلوک تصادفی 4 تایی در دو گروه بيهوشی کامل داخل وريدی و بيهوشی استنشاقی قرار میگیرند. این مطالعه به صورت کارازمایی بالینی سه سو کور به این صورت که بیماران، اندازه گیری کنندگان پیامدهای مطالعه (پژوهشگران) و یا کمیته پایش اطلاعات (تحلیل کنندگان) از این که بیماران چه مداخله ای را دریافت نموده اند ناآگاه هستند. فاز کارآزمایی بالینی 3 هست.
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Inclusion criteria: Age between 30 to 70 years; ASA class III and IV, exclusion criteria: Complications during or after laparoscopic surgery.
Inclusion criteria: Age between 30 to 70 years; ASA class III and IV, exclusion criteria: Complications during or after laparoscopic surgery.
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معیارهای ورود بر مطالعه عبارتند از: محدوده سنی بین 70-30 سال؛ ASA کلاس 3 و 4، معیارهای خروج: عوارض حین یا بعد از عمل جراحی لاپاراسکوپی
معیارهای ورود بر مطالعه عبارتند از: محدوده سنی بین 70-30 سال؛ ASA کلاس 3 و 4، معیارهای خروج: عوارض حین یا بعد از عمل جراحی لاپاراسکوپی
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Intervention 1: In the anesthetic inhalation group, for induction, sodium thiopental 4 mg/kg used. Isoflurane 1-2.1% used for maintenance anesthesia.
Intervention 2: In the complete intravenous anesthetic group, for induction, Etomidate 3.0 µg/kg is used. For maintenance of anesthesia, Etomidate 100 µg/kg for the first 10 minutes after induction and followed by 20 µg/kg for up to 10 minutes until the end of the surgery used.
Intervention 1: In the anesthetic inhalation group, for induction, sodium thiopental 4 mg/kg used. Isoflurane 1-2.1% used for maintenance anesthesia. Intervention 2: In the complete intravenous anesthetic group, for induction, Etomidate 3.0 µg/kg is used. For maintenance of anesthesia, Etomidate 100 µg/kg for the first 10 minutes after induction and followed by 20 µg/kg for up to 10 minutes until the end of the surgery used.
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مداخله 1: در گروه بيهوشی استنشاقی برای اينداکشن از تيوپنتال سديم 4 ميلی گرم/کيلوگرم و برای حفظ بيهوشی از هوشبر استنشاقی ايزوفلوران 1-2.1 درصد استفاده مي شود.
در گروه بيهوشی کامل داخل وريدی برای اينداکشن از اتوميديت 3.0 ماکروگرم/کيلوگرم و برای حفظ اتوميديت با دوز 100 ماکروگرم/کيلوگرم برای 10 دقيقه اول بعد از اينداکشن و بعد 20 ماکروگرم/کيلوگرم تا 10 دقيقه مانده به پايان عمل جراحی استفاده ميشود.
مداخله 1: در گروه بيهوشی استنشاقی برای اينداکشن از تيوپنتال سديم 4 ميلی گرم/کيلوگرم و برای حفظ بيهوشی از هوشبر استنشاقی ايزوفلوران 1-2.1 درصد استفاده مي شود. در گروه بيهوشی کامل داخل وريدی برای اينداکشن از اتوميديت 3.0 ماکروگرم/کيلوگرم و برای حفظ اتوميديت با دوز 100 ماکروگرم/کيلوگرم برای 10 دقيقه اول بعد از اينداکشن و بعد 20 ماکروگرم/کيلوگرم تا 10 دقيقه مانده به پايان عمل جراحی استفاده ميشود.
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Hemodynamic changes include systolic and diastolic blood pressure, arterial blood pressure and heart rate.
Hemodynamic changes include systolic and diastolic blood pressure, arterial blood pressure and heart rate.
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تغييرات هموديناميک شامل فشار خون سيستوليک و دياستوليک، فشار خون متوسط شريانی و تعداد ضربان قلب
تغييرات هموديناميک شامل فشار خون سيستوليک و دياستوليک، فشار خون متوسط شريانی و تعداد ضربان قلب
General information
Double blinded
Triple blinded
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Clinical trial comparing the homodynamic changes in two methods of complete intravenous and inhalation anesthetics in renal transplant patients with peritoneal catheterization with laparoscopy
Clinical trial comparing the homodynamic changes in two methods of complete intravenous and inhalation anesthetics in patients candidate for laparoscopy peritoneal catheterization
Clinical trial comparing the homodynamic changes in two methods of complete intravenous and inhalation anesthetics in renal transplant patients withcandidate for laparoscopy peritoneal catheterization with laparoscopy
Age between 30 to 70 years
ASA class III and IV
Age between 30 to 70 years ASA class III and IV
محدوده سنی بین30 تا 70 سال
ASA کلاس 3 و 4
محدوده سنی بین30 تا 70 سال ASA کلاس 3 و 4
Complications during or after laparoscopic surgery
Complications during or after laparoscopic surgery
عوارض حین یا بعد از عمل جراحی لاپاراسکوپی
عوارض حین یا بعد از عمل جراحی لاپاراسکوپی
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Random method: Block, Random unit: individual, Random Tool: Random Block 4
Random method: Block, Random unit: individual, Random Tool: Random Block 4
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روش تصادفی سازی: بلوک، واحد تصادفی سازی: فردی، ابزار تصادفی سازی: بلوک تصادفی 4 تایی
روش تصادفی سازی: بلوک، واحد تصادفی سازی: فردی، ابزار تصادفی سازی: بلوک تصادفی 4 تایی
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In this study, the patients, measuring the outcomes of study participants (researchers) or Data Monitoring Committee (analyzers) of the patients unaware of intervention.
In this study, the patients, measuring the outcomes of study participants (researchers) or Data Monitoring Committee (analyzers) of the patients unaware of intervention.
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این مطالعه به صورت کارازمایی بالینی سه سو کور به این صورت که بیماران، اندازه گیری کنندگان پیامدهای مطالعه (پژوهشگران) و یا کمیته پایش اطلاعات (تحلیل کنندگان) از این که بیماران چه مداخله ای را دریافت نموده اند ناآگاه هستند.
این مطالعه به صورت کارازمایی بالینی سه سو کور به این صورت که بیماران، اندازه گیری کنندگان پیامدهای مطالعه (پژوهشگران) و یا کمیته پایش اطلاعات (تحلیل کنندگان) از این که بیماران چه مداخله ای را دریافت نموده اند ناآگاه هستند.
Primary outcomes
#1
First visit to the operating room, after the induction, after intubation, before the injection into the abdominal cavity, after the injection of the gas into the abdominal cavity and then in the recovery room
First visit the operating room, after the induction, after intubation, before the gas injection into the abdominal cavity, after the injection of the gas into the abdominal cavity and then in the recovery room
First visit to the operating room, after the induction, after intubation, before the gas injection into the abdominal cavity, after the injection of the gas into the abdominal cavity and then in the recovery room
Invasive blood pressure monitor
Noninvasive blood pressure monitor
InvasiveNoninvasive blood pressure monitor
دستگاه فشار سنج تهاجمی
دستگاه فشار سنج غیر تهاجمی
دستگاه فشار سنج غیر تهاجمی
#2
First visit to the operating room, after the induction, after intubation, before the injection into the abdominal cavity, after the injection of the gas into the abdominal cavity and then in the recovery room
First visit the operating room, after the induction, after intubation, before the gas injection into the abdominal cavity, after the injection of the gas into the abdominal cavity and then in the recovery room
First visit to the operating room, after the induction, after intubation, before the gas injection into the abdominal cavity, after the injection of the gas into the abdominal cavity and then in the recovery room
Invasive blood pressure monitor
Noninvasive blood pressure monitor
InvasiveNoninvasive blood pressure monitor
دستگاه فشار سنج تهاجمی
دستگاه فشار سنج غیر تهاجمی
دستگاه فشار سنج غیر تهاجمی
#3
First visit to the operating room, after the induction, after intubation, before the injection into the abdominal cavity, after the injection of the gas into the abdominal cavity and then in the recovery room
First visit the operating room, after the induction, after intubation, before the gas injection into the abdominal cavity, after the injection of the gas into the abdominal cavity and then in the recovery room
First visit to the operating room, after the induction, after intubation, before the gas injection into the abdominal cavity, after the injection of the gas into the abdominal cavity and then in the recovery room
Invasive blood pressure monitor
Noninvasive blood pressure monitor
InvasiveNoninvasive blood pressure monitor
دستگاه فشار سنج تهاجمی
دستگاه فشار سنج غیر تهاجمی
دستگاه فشار سنج غیر تهاجمی
Secondary outcomes
#1
First visit to the operating room, after the induction, after intubation, before the injection into the abdominal cavity, after the injection of the gas into the abdominal cavity and then in the recovery room
First visit the operating room, after the induction, after intubation, before the gas injection into the abdominal cavity, after the injection of the gas into the abdominal cavity and then in the recovery room
First visit to the operating room, after the induction, after intubation, before the gas injection into the abdominal cavity, after the injection of the gas into the abdominal cavity and then in the recovery room
Manitor
Monitor
ManitorMonitor
Intervention groups
#1
Control group: In the complete intravenous anesthetic group, for induction, Etomidate 3.0 mg/kg is used. For maintenance of anesthesia, Etomidate 100 mg/kg for the first 10 minutes after induction and followed by 20 mg/kg for up to 10 minutes until the end of the surgery is used.
Control group: In the complete intravenous anesthetic group, for induction, Etomidate 3.0 µg/kg is used. For maintenance of anesthesia, Etomidate 100 µg/kg for the first 10 minutes after induction and followed by 20 mµg/kg for up to 10 minutes until the end of the surgery is used.
Control group: In the complete intravenous anesthetic group, for induction, Etomidate 3.0 mgµg/kg is used. For maintenance of anesthesia, Etomidate 100 mgµg/kg for the first 10 minutes after induction and followed by 20 mgmµg/kg for up to 10 minutes until the end of the surgery is used.
گروه کنترل: بيهوشی کامل داخل وريدی برای اينداکشن از اتوميديت 3.0 ميلی گرم/کيلوگرم و برای حفظ اتوميديت با دوز 100 ميکروگرم/کيلوگرم برای 10 دقيقه اول بعد از اينداکشن و بعد 20 ماکروگرم/کيلوگرم تا 10 دقيقه مانده به پايان عمل جراحی استفاده ميشود.
گروه کنترل: بيهوشی کامل داخل وريدی برای اينداکشن از اتوميديت 3.0 ماکروگرم/کيلوگرم و برای حفظ اتوميديت با دوز 100 ماکروگرم/کيلوگرم برای 10 دقيقه اول بعد از اينداکشن و بعد 20 ماکروگرم/کيلوگرم تا 10 دقيقه مانده به پايان عمل جراحی استفاده ميشود.
گروه کنترل: بيهوشی کامل داخل وريدی برای اينداکشن از اتوميديت 3.0 ميلی گرمماکروگرم/کيلوگرم و برای حفظ اتوميديت با دوز 100 ميکروگرمماکروگرم/کيلوگرم برای 10 دقيقه اول بعد از اينداکشن و بعد 20 ماکروگرم/کيلوگرم تا 10 دقيقه مانده به پايان عمل جراحی استفاده ميشود.
#2
گروه مداخله: در بيهوشی استنشاقی برای اينداکشن از تيوپنتال سديم 4ميلی گرم/کيلوگرم و برای حفظ بيهوشی از هوشبر استنشاقی ايزوفلوران 1-2.1 درصد استفاده ميشود.
گروه مداخله: در بيهوشی استنشاقی برای اينداکشن از تيوپنتال سديم 4 ميلی گرم/کيلوگرم و برای حفظ بيهوشی از هوشبر استنشاقی ايزوفلوران 1-2.1 درصد استفاده ميشود.
گروه مداخله: در بيهوشی استنشاقی برای اينداکشن از تيوپنتال سديم 4ميلی4 ميلی گرم/کيلوگرم و برای حفظ بيهوشی از هوشبر استنشاقی ايزوفلوران 1-2.1 درصد استفاده ميشود.
Recruitment centers
#1
Name of recruitment center - English: Imam Khomeini Hospital of Tehran University of Medical Sciences
Name of recruitment center - Persian: بيمارستان امام خمينی دانشگاه علوم پزشکی تهران
Full name of responsible person - English: Mojgan Rahimi
Full name of responsible person - Persian: مژگان رحیمی
Street address - English: Imam Khomeini Hospital, Keshavarz Blv
Street address - Persian: بلوار کشاورز، بيمارستان امام خمينی
City - English: Tehran
City - Persian: تهران
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Imam Khomeini Hospital of Tehran University of Medical Sciences
Name of recruitment center - Persian: بيمارستان امام خمينی دانشگاه علوم پزشکی تهران
Full name of responsible person - English: Mojgan Rahimi
Full name of responsible person - Persian: مژگان رحیمی
Street address - English: Imam Khomeini Hospital, Keshavarz Blv
Street address - Persian: بلوار کشاورز، بيمارستان امام خمينی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 134567222
Phone: +98 21 8805 3766
Fax:
Email: mrahimi@tums.ac.ir
Web page address:
Name of recruitment center - English: Imam Khomeini Hospital of Tehran University of Medical Sciences Name of recruitment center - Persian: بيمارستان امام خمينی دانشگاه علوم پزشکی تهران Full name of responsible person - English: Mojgan Rahimi Full name of responsible person - Persian: مژگان رحیمی Street address - English: Imam Khomeini Hospital, Keshavarz Blv Street address - Persian: بلوار کشاورز، بيمارستان امام خمينی City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 134567222 Phone: +98 21 8805 3766 Fax: Email: mrahimi@tums.ac.ir Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Vice chancellor for research, Tehran University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی، دانشگاه علوم پزشکی تهران
Full name of responsible person - English: Dr. Masoud Yunesian
Full name of responsible person - Persian: دكتر مسعود يونسيان
Street address - English: Tehran University of Medical Sciences, Keshavarz Blvd
Street address - Persian: بلوار كشاورز، دانشگاه علوم پزشكي تهران
City - English: Tehran
City - Persian: تهران
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Vice chancellor for research, Tehran University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی، دانشگاه علوم پزشکی تهران
Full name of responsible person - English: Dr. Masoud Yunesian
Full name of responsible person - Persian: دكتر مسعود يونسيان
Street address - English: Tehran University of Medical Sciences, Keshavarz Blvd
Street address - Persian: بلوار كشاورز، دانشگاه علوم پزشكي تهران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 134567222
Phone: +98 21 6605 2421
Fax:
Email: mrahimi@tums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Vice chancellor for research, Tehran University of Medical Sciences Name of organization / entity - Persian: معاونت پژوهشی، دانشگاه علوم پزشکی تهران Full name of responsible person - English: Dr. Masoud Yunesian Full name of responsible person - Persian: دكتر مسعود يونسيان Street address - English: Tehran University of Medical Sciences, Keshavarz Blvd Street address - Persian: بلوار كشاورز، دانشگاه علوم پزشكي تهران City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 134567222 Phone: +98 21 6605 2421 Fax: Email: mrahimi@tums.ac.ir Web page address:
empty
Public
public
empty
Domestic
domestic
empty
Academic
academic
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Tehran University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشكي تهران
Full name of responsible person - English: Razieh Erfani
Full name of responsible person - Persian: راضیه عرفانی
Position - English: Student, Anesthesiology Assistant
Position - Persian: دستیاری بیهوشی/دانشجو
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Tehran University of Medical Sciences, Keshavarz Blvd
Street address - Persian: بلوار كشاورز، دانشگاه علوم پزشكي تهران
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +91 55617968
Mobile: 00
Fax:
Email: razierfani@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Tehran University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشكي تهران
Full name of responsible person - English: Razieh Erfani
Full name of responsible person - Persian: راضیه عرفانی
Position - English: Student, Anesthesiology Assistant
Position - Persian: دستیاری بیهوشی/دانشجو
Latest degree: med_doctor
Area of specialty/work: 24
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Tehran University of Medical Sciences, Keshavarz Blvd
Street address - Persian: بلوار كشاورز، دانشگاه علوم پزشكي تهران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 134567222
Phone: +91 55617968
Mobile: +98 912 148 7259
Fax:
Email: razierfani@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Tehran University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشكي تهران Full name of responsible person - English: Razieh Erfani Full name of responsible person - Persian: راضیه عرفانی Position - English: Student, Anesthesiology Assistant Position - Persian: دستیاری بیهوشی/دانشجو Latest degree: med_doctor Area of specialty/work: 024 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Tehran University of Medical Sciences, Keshavarz Blvd Street address - Persian: بلوار كشاورز، دانشگاه علوم پزشكي تهران City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 134567222 Phone: +91 55617968 Mobile: 00+98 912 148 7259 Fax: Email: razierfani@yahoo.com Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Tehran University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشكي تهران
Full name of responsible person - English: Mojgan Rahimi
Full name of responsible person - Persian: مژگان رحیمی
Position - English: Faculty member/Anesthesiologist
Position - Persian: عضو هیئت علمی/ متخصص بیهوشی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Tehran University of Medical Sciences, Keshavarz Blvd
Street address - Persian: بلوار كشاورز، دانشگاه علوم پزشكي تهران
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: 00
Mobile: 00
Fax:
Email: mrahimi@tums.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Tehran University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشكي تهران
Full name of responsible person - English: Mojgan Rahimi
Full name of responsible person - Persian: مژگان رحیمی
Position - English: Faculty member/Anesthesiologist
Position - Persian: عضو هیئت علمی/ متخصص بیهوشی
Latest degree: specialist
Area of specialty/work: 24
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Tehran University of Medical Sciences, Keshavarz Blvd
Street address - Persian: بلوار كشاورز، دانشگاه علوم پزشكي تهران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 134567222
Phone: +98 216604421
Mobile: +98 912 148 7252
Fax:
Email: mrahimi@tums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Tehran University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشكي تهران Full name of responsible person - English: Mojgan Rahimi Full name of responsible person - Persian: مژگان رحیمی Position - English: Faculty member/Anesthesiologist Position - Persian: عضو هیئت علمی/ متخصص بیهوشی Latest degree: specialist Area of specialty/work: 024 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Tehran University of Medical Sciences, Keshavarz Blvd Street address - Persian: بلوار كشاورز، دانشگاه علوم پزشكي تهران City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 134567222 Phone: 00+98 216604421 Mobile: 00+98 912 148 7252 Fax: Email: mrahimi@tums.ac.ir Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Tehran University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشكي تهران
Full name of responsible person - English: Razieh Erfani
Full name of responsible person - Persian: راضیه عرفانی
Position - English: Anesthesiology Assistant
Position - Persian: دستیاری بیهوشی/دانشجو
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Tehran University of Medical Sciences, Keshavarz Blvd
Street address - Persian: بلوار كشاورز، دانشگاه علوم پزشكي تهران
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: 00
Mobile: +98 915 561 7968
Fax:
Email: razierfani@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Tehran University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشكي تهران
Full name of responsible person - English: Razieh Erfani
Full name of responsible person - Persian: راضیه عرفانی
Position - English: Anesthesiology Assistant
Position - Persian: دستیاری بیهوشی/دانشجو
Latest degree: med_doctor
Area of specialty/work: 24
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Tehran University of Medical Sciences, Keshavarz Blvd
Street address - Persian: بلوار كشاورز، دانشگاه علوم پزشكي تهران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 134567222
Phone: +98 216604422
Mobile: +98 912 148 7252
Fax:
Email: razierfani@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Tehran University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشكي تهران Full name of responsible person - English: Razieh Erfani Full name of responsible person - Persian: راضیه عرفانی Position - English: Anesthesiology Assistant Position - Persian: دستیاری بیهوشی/دانشجو Latest degree: med_doctor Area of specialty/work: 024 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Tehran University of Medical Sciences, Keshavarz Blvd Street address - Persian: بلوار كشاورز، دانشگاه علوم پزشكي تهران City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 134567222 Phone: 00+98 216604422 Mobile: +98 915 561 7968912 148 7252 Fax: Email: razierfani@yahoo.com Web page address:
Sharing plan
yes
yes
no
no
no
no
no
no
yes
yes
no
no
no
no
empty
Journals of medical sciences
Journals of medical sciences
empty
مجلات علوم پزشکی
مجلات علوم پزشکی
empty
From 2019
From 2019
empty
از سال 1397
از سال 1397
empty
Researchers working in academia, science and industry
Researchers working in academia, science and industry
empty
محققین شاغل در موسسات دانشگاهی، علمی و صنعت
محققین شاغل در موسسات دانشگاهی، علمی و صنعت
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None
None
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ندارد
ندارد
empty
Researchers
Researchers
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محققین
محققین
empty
Researchers
Researchers
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محققین
محققین
Protocol summary
Study aim
Evaluate the hemodynamic changes in two methods of complete intravenous and inhalation anesthesia in patients candidate for laparoscopy peritoneal catheterization
Design
Intervention 1: In the anesthetic inhalation group, for induction, sodium thiopental 4 mg/kg used. Isoflurane 1-2.1% used for maintenance anesthesia.
Intervention 2: In the complete intravenous anesthetic group, for induction, Etomidate 3.0 µg/kg is used. For maintenance of anesthesia, Etomidate 100 µg/kg for the first 10 minutes after induction and followed by 20 µg/kg for up to 10 minutes until the end of the surgery used. Clinical trial phase: 3.
Settings and conduct
The aim of the study is to evaluate the hemodynamic changes in two methods of complete intravenous and inhalation anesthesia in patients candidate for laparoscopy peritoneal catheterization
The study conducted in the Emam Khomeini hospital of Tehran city.
Seventy patients were randomly assigned into two groups of complete anesthesia and inhalation anesthesia using random block method.
In this study, the patients, measuring the outcomes of study participants (researchers) or Data Monitoring Committee (analyzers) of the patients unaware of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 30 to 70 years; ASA class III and IV, exclusion criteria: Complications during or after laparoscopic surgery.
Intervention groups
Intervention 1: In the anesthetic inhalation group, for induction, sodium thiopental 4 mg/kg used. Isoflurane 1-2.1% used for maintenance anesthesia.
Intervention 2: In the complete intravenous anesthetic group, for induction, Etomidate 3.0 µg/kg is used. For maintenance of anesthesia, Etomidate 100 µg/kg for the first 10 minutes after induction and followed by 20 µg/kg for up to 10 minutes until the end of the surgery used.
Main outcome variables
Hemodynamic changes include systolic and diastolic blood pressure, arterial blood pressure and heart rate.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT2017070934978N1
Registration date:2017-08-17, 1396/05/26
Registration timing:registered_while_recruiting
Last update:2018-03-19, 1396/12/28
Update count:1
Registration date
2017-08-17, 1396/05/26
Registrant information
Name
Mojgan Rahimi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 84426391
Email address
mrahimi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-08-22, 1396/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial comparing the homodynamic changes in two methods of complete intravenous and inhalation anesthetics in patients candidate for laparoscopy peritoneal catheterization
Public title
Comparison of hemodynamic changes in both intravenous and inhalation anesthetics
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 30 to 70 years
ASA class III and IV
Exclusion criteria:
Complications during or after laparoscopic surgery
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Random method: Block, Random unit: individual, Random Tool: Random Block 4
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, the patients, measuring the outcomes of study participants (researchers) or Data Monitoring Committee (analyzers) of the patients unaware of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshvarz Blvd
City
Tehran
Province
Tehran
Postal code
1345789522
Approval date
2016-12-26, 1395/10/06
Ethics committee reference number
IR.TUMS.VCR.REC.1395.1316
Health conditions studied
1
Description of health condition studied
End Stage Renal Disease
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease
Primary outcomes
1
Description
Systolic blood pressure
Timepoint
First visit the operating room, after the induction, after intubation, before the gas injection into the abdominal cavity, after the injection of the gas into the abdominal cavity and then in the recovery room
Method of measurement
Noninvasive blood pressure monitor
2
Description
Diastolic blood pressure
Timepoint
First visit the operating room, after the induction, after intubation, before the gas injection into the abdominal cavity, after the injection of the gas into the abdominal cavity and then in the recovery room
Method of measurement
Noninvasive blood pressure monitor
3
Description
Mean arterial blood pressure
Timepoint
First visit the operating room, after the induction, after intubation, before the gas injection into the abdominal cavity, after the injection of the gas into the abdominal cavity and then in the recovery room
Method of measurement
Noninvasive blood pressure monitor
Secondary outcomes
1
Description
Heart rate per minute
Timepoint
First visit the operating room, after the induction, after intubation, before the gas injection into the abdominal cavity, after the injection of the gas into the abdominal cavity and then in the recovery room
Method of measurement
Monitor
Intervention groups
1
Description
Control group: In the complete intravenous anesthetic group, for induction, Etomidate 3.0 µg/kg is used. For maintenance of anesthesia, Etomidate 100 µg/kg for the first 10 minutes after induction and followed by 20 mµg/kg for up to 10 minutes until the end of the surgery is used.
Category
Other
2
Description
Intervention group: In the anesthetic inhalation group, for induction, sodium thiopental 4 mg/kg is used. Isoflurane 1-2.1% is used for maintenance anesthesia.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital of Tehran University of Medical Sciences
Full name of responsible person
Mojgan Rahimi
Street address
Imam Khomeini Hospital, Keshavarz Blv
City
Tehran
Province
Tehran
Postal code
134567222
Phone
+98 21 8805 3766
Email
mrahimi@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoud Yunesian
Street address
Tehran University of Medical Sciences, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
134567222
Phone
+98 21 6605 2421
Email
mrahimi@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Razieh Erfani
Position
Student, Anesthesiology Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Tehran University of Medical Sciences, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
134567222
Phone
+91 55617968
Fax
Email
razierfani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mojgan Rahimi
Position
Faculty member/Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Tehran University of Medical Sciences, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
134567222
Phone
+98 216604421
Fax
Email
mrahimi@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Razieh Erfani
Position
Anesthesiology Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Tehran University of Medical Sciences, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
134567222
Phone
+98 216604422
Fax
Email
razierfani@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Journals of medical sciences
When the data will become available and for how long
From 2019
To whom data/document is available
Researchers working in academia, science and industry
Under which criteria data/document could be used
None
From where data/document is obtainable
Researchers
What processes are involved for a request to access data/document