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Protocol summary
Since, magnesium relaxant effect on muscular, we aimed to evaluate effect of intravenous magnesium sulfate infusion on intraoperative analgesia quality and muscle relaxation in patients undergo cesarean section with epidural analgesia. In current randomized double-blinded clinical trial, 66 women aged between 28 to 40 years old with term singleton pregnancy candidate for elective cesarean section with epidural analgesia will be enrolled and women suffering systemic diseases, mental disorders and body mass index more than 35 kilograms per meter square will be excluded.
Prior to surgery, equally patients will be divided to control and study groups. In operation room, epidural analgesia will be induced in L3-4 or L4-5 intervertebral spaces. Subsequent to delivery and umbilicus clamping, in study group 15 milligrams per kilograms’ magnesium sulfate will be infused till end of the operation and in control group same volume of normal saline will be infused during operation.
Study variables including patient’s analgesia grade and patient’s comfort grade will be asked from patients and questions considering muscle relaxation degree will be answered by surgeon. In addition, preoperative and post-operative patients’ body temperature will be measured. At the end of the operation, study solutions infusion will be discontinued and patient will be referred to post-anesthesia care unit (PACU) and sensory block and motor block duration and peri-operative complications will be recorded. In addition, intraoperative administration of supplement systemic anesthetics will be noted.
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Since, magnesium relaxant effect on muscular, we aimed to evaluate effect of intravenous magnesium sulfate infusion on intraoperative analgesia quality and muscle relaxation in patients undergo cesarean section with epidural analgesia. In current randomized double-blinded clinical trial, 66 women aged between 28 to 40 years old with term singleton pregnancy candidate for elective cesarean section with epidural analgesia will be enrolled and women suffering systemic diseases, mental disorders and body mass index more than 35 kilograms per meter square will be excluded. Prior to surgery, equally patients will be divided to control and study groups. In operation room, epidural analgesia will be induced in L3-4 or L4-5 intervertebral spaces. Subsequent to delivery and umbilicus clamping, in study group 15 milligrams per kilograms’ magnesium sulfate will be infused till end of the operation and in control group same volume of normal saline will be infused during operation. Study variables including patient’s analgesia grade and patient’s comfort grade will be asked from patients and questions considering muscle relaxation degree will be answered by surgeon. In addition, preoperative and post-operative patients’ body temperature will be measured. At the end of the operation, study solutions infusion will be discontinued and patient will be referred to post-anesthesia care unit (PACU) and sensory block and motor block duration and peri-operative complications will be recorded. In addition, intraoperative administration of supplement systemic anesthetics will be noted.
با توجه به اثرات شل كنندگي عضلاني منيزيم، به بررسي اثر انفوزيون داخل وريدي سولفات منيزيم بعد از بي حسی نخاعي در بيماران تحت سزارين روي كيفيت بی حسی و شلی عضلانی حين عمل می پردازیم. در این کارآزمایی بالینی تصادفی و دو سو کور ، ۶۶ خانم در سنين ۱۸ تا ۴۰ سالگی با حاملگي ترم تك قلو و كانديداي سزارين الكتيو با بي حسی نخاعي وارد مطالعه شده و خانم های بیماری های سیستمیک، بیماری های روانی و شاخص توده بدنی بیش از ۳۵ کیلوگرم بر متر مربع از مطالعه خارج خواهند شد.
بیماران پیش از عمل به طور تصادفی به دو گروه مساوی کنترل و مطالعه تقسیم می شوند. در اتاق عمل بي حس نخاعي از فضاي بين مهره اي کمری ۳ و ۴ يا ۴ و ۵ صورت می گیرد. بلافاصله بعد از زايمان نوزاد و كلامپ بند ناف، در گروه مطالعه حدود ۱۵ میلی گرم بر کیلوگرم سولفات منيزيم تا پايان جراحي و در گروه کنترل با همان حجم سالن نرمال انفوزیون خواهد شد.
پارامترهاي مطالعه شامل درجه بی دردی بيماران و درجه راحتي از خود بيمار و درجه شلي عضلاني از جراح سوال مي شود. هم چنین، درجه حرارت بیمار قبل و بعد از عمل اندازه گیری می شود. در پايان عمل انفوزيون محلولهاي مطالعه قطع و بيمار به واحد مراقبت پس از عمل منتقل شده و مدت بلوك حسی و مدت بلوك حركتي و عوارض جانبی پری اپراتیو يادداشت مي شود. هم چنین، نیاز بیماران به دارو های بیهوشی سیستمیک کمکی ثبت خواهد شد.
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با توجه به اثرات شل كنندگي عضلاني منيزيم، به بررسي اثر انفوزيون داخل وريدي سولفات منيزيم بعد از بي حسی نخاعي در بيماران تحت سزارين روي كيفيت بی حسی و شلی عضلانی حين عمل می پردازیم. در این کارآزمایی بالینی تصادفی و دو سو کور ، ۶۶ خانم در سنين ۱۸ تا ۴۰ سالگی با حاملگي ترم تك قلو و كانديداي سزارين الكتيو با بي حسی نخاعي وارد مطالعه شده و خانم های بیماری های سیستمیک، بیماری های روانی و شاخص توده بدنی بیش از ۳۵ کیلوگرم بر متر مربع از مطالعه خارج خواهند شد. بیماران پیش از عمل به طور تصادفی به دو گروه مساوی کنترل و مطالعه تقسیم می شوند. در اتاق عمل بي حس نخاعي از فضاي بين مهره اي کمری ۳ و ۴ يا ۴ و ۵ صورت می گیرد. بلافاصله بعد از زايمان نوزاد و كلامپ بند ناف، در گروه مطالعه حدود ۱۵ میلی گرم بر کیلوگرم سولفات منيزيم تا پايان جراحي و در گروه کنترل با همان حجم سالن نرمال انفوزیون خواهد شد. پارامترهاي مطالعه شامل درجه بی دردی بيماران و درجه راحتي از خود بيمار و درجه شلي عضلاني از جراح سوال مي شود. هم چنین، درجه حرارت بیمار قبل و بعد از عمل اندازه گیری می شود. در پايان عمل انفوزيون محلولهاي مطالعه قطع و بيمار به واحد مراقبت پس از عمل منتقل شده و مدت بلوك حسی و مدت بلوك حركتي و عوارض جانبی پری اپراتیو يادداشت مي شود. هم چنین، نیاز بیماران به دارو های بیهوشی سیستمیک کمکی ثبت خواهد شد.
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Effect of Magnesium Sulfate Infusion on Muscle Relaxation after Spinal Anesthesia for Cesarean Delivery
Effect of Magnesium Sulfate Infusion on Muscle Relaxation after Spinal Anesthesia for Cesarean Delivery
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اثر انفوزیون سولفات منیزیوم روی شلی عضلانی بعد از بی حسی نخاعی برای زایمان سزارین
اثر انفوزیون سولفات منیزیوم روی شلی عضلانی بعد از بی حسی نخاعی برای زایمان سزارین
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Randomised, double blinded clinical trial, randomisation was promoted by the method of randomly permuted blocks using Rand software
Randomised, double blinded clinical trial, randomisation was promoted by the method of randomly permuted blocks using Rand software
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کارآزمایی بالینی دارای گروه کنترل، با گروه مداخله ، دو سویه کور ، تصادفی شده
کارآزمایی بالینی دارای گروه کنترل، با گروه مداخله ، دو سویه کور ، تصادفی شده
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The randomized clinical trial study will conducted on 66 women aged between 18 to 40 years old with term singleton pregnancy candidate for elective cesarean section with epidural analgesia at Al-Zahra hospital of Tabriz University in the period of April 6th, 2017 to September 20th, 2017.Prior to surgery, equally patients will be divided to control and study groups. In operation room, epidural analgesia will be induced in L3-4 or L4-5 intervertebral spaces. Subsequent to delivery and umbilicus clamping, in study group 15 milligrams per kilograms’ magnesium sulfate will be infused till end of the operation and in control group same volume of normal saline will be infused.This study will be double blind in which physician and patients are blind to treatment protocols.
The randomized clinical trial study will conducted on 66 women aged between 18 to 40 years old with term singleton pregnancy candidate for elective cesarean section with epidural analgesia at Al-Zahra hospital of Tabriz University in the period of April 6th, 2017 to September 20th, 2017.Prior to surgery, equally patients will be divided to control and study groups. In operation room, epidural analgesia will be induced in L3-4 or L4-5 intervertebral spaces. Subsequent to delivery and umbilicus clamping, in study group 15 milligrams per kilograms’ magnesium sulfate will be infused till end of the operation and in control group same volume of normal saline will be infused.This study will be double blind in which physician and patients are blind to treatment protocols.
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این مطالعه به صورت کار آزمایی بالینی تصادفی بر روی ۶۶ خانم در سنين ۱۸ تا ۴۰ سالگی با حاملگي ترم تك قلو و كانديداي سزارين الكتيو با بي حسی نخاعي در بیمارستان الزهرا از تاریخ 17 فروردین 1396 تا 29 شهریور 1396 انجام خواهد شد.بیماران پیش از عمل به طور تصادفی به دو گروه مساوی کنترل و مطالعه تقسیم می شوند.در اتاق عمل بي حس نخاعي از فضاي بين مهره اي کمری ۳ و ۴ يا ۴ و ۵ صورت می گیرد. بلافاصله بعد از زايمان نوزاد و كلامپ بند ناف، در گروه مطالعه حدود ۱۵ میلی گرم بر کیلوگرم سولفات منيزيم تا پايان جراحي و در گروه کنترل با همان حجم سالن نرمال انفوزیون خواهد شد.این مطالعه دوسویه کور بوده و پزشک معالج و بیماران به پروتکل های درمان کور می شوند.
این مطالعه به صورت کار آزمایی بالینی تصادفی بر روی ۶۶ خانم در سنين ۱۸ تا ۴۰ سالگی با حاملگي ترم تك قلو و كانديداي سزارين الكتيو با بي حسی نخاعي در بیمارستان الزهرا از تاریخ 17 فروردین 1396 تا 29 شهریور 1396 انجام خواهد شد.بیماران پیش از عمل به طور تصادفی به دو گروه مساوی کنترل و مطالعه تقسیم می شوند.در اتاق عمل بي حس نخاعي از فضاي بين مهره اي کمری ۳ و ۴ يا ۴ و ۵ صورت می گیرد. بلافاصله بعد از زايمان نوزاد و كلامپ بند ناف، در گروه مطالعه حدود ۱۵ میلی گرم بر کیلوگرم سولفات منيزيم تا پايان جراحي و در گروه کنترل با همان حجم سالن نرمال انفوزیون خواهد شد.این مطالعه دوسویه کور بوده و پزشک معالج و بیماران به پروتکل های درمان کور می شوند.
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Inclusion criteria included term parturient with ASA I or II, 18-40 years age, scheduled for elective cesarean section with spinal anesthesia. Exclusion criteria included parturient who needed emergency cesarean section, had co-existing systemic diseases,any history of psychological disorder, obesity of BMI>35, history of calcium channel blockers use, recent magnesium consumption, contraindication of spinal anesthesia.
Inclusion criteria included term parturient with ASA I or II, 18-40 years age, scheduled for elective cesarean section with spinal anesthesia. Exclusion criteria included parturient who needed emergency cesarean section, had co-existing systemic diseases,any history of psychological disorder, obesity of BMI>35, history of calcium channel blockers use, recent magnesium consumption, contraindication of spinal anesthesia.
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معیارهای ورود به مطالعه
1-کلاس I یا II درجه بندی ASA
2- سن 40-18 سال
3-کاندیدای سزارین الکتیو
معیارهای خروج از مطالعه
1-سزارین اورزانس
2- بیماری های سیستمیک( قلبی ، تنفسی ، کلیوی ، کبدی و ..)
3- بیماری روانی
4- BMI>35kg/m2
5- مصرف داروهای بلوک کننده کانال کلسیم
6- مصرف اخیر منیزیوم
7- کنترااندیکاسیون بی حسی نخاعی
معیارهای ورود به مطالعه 1-کلاس I یا II درجه بندی ASA 2- سن 40-18 سال 3-کاندیدای سزارین الکتیو معیارهای خروج از مطالعه 1-سزارین اورزانس 2- بیماری های سیستمیک( قلبی ، تنفسی ، کلیوی ، کبدی و ..) 3- بیماری روانی 4- BMI>35kg/m2 5- مصرف داروهای بلوک کننده کانال کلسیم 6- مصرف اخیر منیزیوم 7- کنترااندیکاسیون بی حسی نخاعی
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After neonate delivery in the study group, magnesium sulfate (15 mg kg-1 in 100 ml 0.9% saline) was infused over 15 minutes. Then, 15 mg/kg/hr. of magnesium sulfate were infused until the end of the surgery. In the placebo group, the same volume of 0.9% saline was infused
After neonate delivery in the study group, magnesium sulfate (15 mg kg-1 in 100 ml 0.9% saline) was infused over 15 minutes. Then, 15 mg/kg/hr. of magnesium sulfate were infused until the end of the surgery. In the placebo group, the same volume of 0.9% saline was infused
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بعد از تولد نوزاد در گروه مداخله منیزیوم سولفات( 15 mg kg-1 در saline100ml ) در مدت 15 دقیقه تزریف شد و سپس 15 mg/kg/hr از سولفات منیزیوم تا پایان جراحی انفوزیون شد. و در گروه کنترل مقدار برابر نرمال سالین تزریق شد.
بعد از تولد نوزاد در گروه مداخله منیزیوم سولفات( 15 mg kg-1 در saline100ml ) در مدت 15 دقیقه تزریف شد و سپس 15 mg/kg/hr از سولفات منیزیوم تا پایان جراحی انفوزیون شد. و در گروه کنترل مقدار برابر نرمال سالین تزریق شد.
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Motor Relaxation
Motor Relaxation
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شلی عضلانی
شلی عضلانی
General information
Single blinded
Double blinded
singldoubl
1
1
1
1
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66
66
2016-09-22, 1395/07/01
2017-04-06, 1396/01/17
20162017-0904-2206 00:00:00
2017-09-23, 1396/07/01
2017-09-20, 1396/06/29
2017-09-2320 00:00:00
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2017-04-06, 1396/01/17
2017-04-06 00:00:00
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2017-09-20, 1396/06/29
2017-09-20 00:00:00
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2017-09-20, 1396/06/29
2017-09-20 00:00:00
class I or II in American society of anesthesiology;
aged between 18-40 years old;
term pregnancy;
singleton pregnancy;
candidate for elective cesarean section;
candidate for epidural analgesia.
class I or II in American society of anesthesiology; aged between 18-40 years old; term pregnancy; singleton pregnancy; candidate for elective cesarean section; candidate for epidural analgesia.
کلاس I یا II درجه بندی ASA
؛ سنين 40-18 سال؛
حاملگی ترم؛
حاملگی تک قلویی؛
كانديداي سزارين انتخابي؛
كانديداي بي حسي نخاعي
کلاس I یا II درجه بندی ASA ؛ سنين 40-18 سال؛ حاملگی ترم؛ حاملگی تک قلویی؛ كانديداي سزارين انتخابي؛ كانديداي بي حسي نخاعي
emergent cesarean section;
systemic diseases (renal, cardiac, pulmonary, hepatic, neuromuscular and etc.)
mental disorders
body mass index more than 35 kilograms per meter square;
calcium channel blockers usage
recent use of magnesium;
contraindications for epidural analgesia.
emergent cesarean section; systemic diseases (renal, cardiac, pulmonary, hepatic, neuromuscular and etc.) mental disorders body mass index more than 35 kilograms per meter square; calcium channel blockers usage recent use of magnesium; contraindications for epidural analgesia.
سزارين اورژانس؛
بيماريهاي سيمتيك (کلیوی ، قلبي، ريوي ، كبدي ، عصبي- عضلاني و...)؛
بيماريهاي رواني؛
شاخص توده بدنی بیش از ۳۵ کیلوگرم بر متر مربع؛
مصرف داروهاي بلوك كننده كانال كلسيم؛
مصرف اخير منيزيم؛
كنترانديكاسيون بي حسی نخاعي.
سزارين اورژانس؛ بيماريهاي سيمتيك (کلیوی ، قلبي، ريوي ، كبدي ، عصبي- عضلاني و...)؛ بيماريهاي رواني؛ شاخص توده بدنی بیش از ۳۵ کیلوگرم بر متر مربع؛ مصرف داروهاي بلوك كننده كانال كلسيم؛ مصرف اخير منيزيم؛ كنترانديكاسيون بي حسی نخاعي.
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Randomization will promoted by the method of randomly permuted blocks using Rand software (Rand list online).
Randomization will promoted by the method of randomly permuted blocks using Rand software (Rand list online).
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تصافی سازی با استفاده از نرم افزار تصادفي شده ( Rand list online ) انجام میشود.
تصافی سازی با استفاده از نرم افزار تصادفي شده ( Rand list online ) انجام میشود.
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This study will be double blind in which physician and patients are blind to treatment protocols.
This study will be double blind in which physician and patients are blind to treatment protocols.
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این مطالعه دوسویه کور است و پزشک معالج و بیماران به پروتکل های درمان کور می شوند.
این مطالعه دوسویه کور است و پزشک معالج و بیماران به پروتکل های درمان کور می شوند.
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Recruitment centers
#1
Name of recruitment center - English: Al Zahra Women's Hospital
Name of recruitment center - Persian: بيمارستان زنان الزهرا
Full name of responsible person - English: Dr. Simin Atashkhoyi
Full name of responsible person - Persian: دکتر سيمين آتش خوئي
Street address - English:
Street address - Persian:
City - English: Tabriz
City - Persian: تبریز
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Al Zahra Women's Hospital
Name of recruitment center - Persian: بيمارستان زنان الزهرا
Full name of responsible person - English: Dr. Simin Atashkhoyi
Full name of responsible person - Persian: دکتر سيمين آتش خوئي
Street address - English: Artesh street
Street address - Persian: خیابان ارتش
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5166614766
Phone: +98 41 3553 9161
Fax:
Email: info@alzahrahosp.tbzmed.ac.ir
Web page address:
Name of recruitment center - English: Al Zahra Women's Hospital Name of recruitment center - Persian: بيمارستان زنان الزهرا Full name of responsible person - English: Dr. Simin Atashkhoyi Full name of responsible person - Persian: دکتر سيمين آتش خوئي Street address - English: Artesh street Street address - Persian: خیابان ارتش City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Country: Iran (Islamic Republic of) Postal code: 5166614766 Phone: +98 41 3553 9161 Fax: Email: info@alzahrahosp.tbzmed.ac.ir Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Tabriz Medical University
Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز
Full name of responsible person - English: Alireza Ostadrahimi
Full name of responsible person - Persian: علیرضا استاد رحیمی
Street address - English: Vice chancellor for research, Tabriz University of medical sceinces, Daneshgah square
Street address - Persian: میدان دانشگاه, دانشگاه علوم پزشکی تبریز, معاونت پژوهشی
City - English: Tabriz
City - Persian: تبریز
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Tabriz Medical University
Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز
Full name of responsible person - English: Alireza Ostadrahimi
Full name of responsible person - Persian: علیرضا استاد رحیمی
Street address - English: Vice chancellor for research, Tabriz University of medical sceinces, Daneshgah square
Street address - Persian: میدان دانشگاه, دانشگاه علوم پزشکی تبریز, معاونت پژوهشی
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5166614766
Phone: +98 41 3335 5921
Fax:
Email: info@medfac.tbzmed.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Tabriz Medical University Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز Full name of responsible person - English: Alireza Ostadrahimi Full name of responsible person - Persian: علیرضا استاد رحیمی Street address - English: Vice chancellor for research, Tabriz University of medical sceinces, Daneshgah square Street address - Persian: میدان دانشگاه, دانشگاه علوم پزشکی تبریز, معاونت پژوهشی City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Country: Iran (Islamic Republic of) Postal code: 5166614766 Phone: +98 41 3335 5921 Fax: Email: info@medfac.tbzmed.ac.ir Web page address:
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Public
public
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Domestic
domestic
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Academic
academic
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Tabriz Medical University
Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز
Full name of responsible person - English: Dr. Simin Atashkhoyi
Full name of responsible person - Persian: دکتر سيمين آتش خوئي
Position - English: Associate Professor, Specialist in Anesthesiology
Position - Persian: متخصص بیهوشی, دانشيار بيهوشي
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Al Zahra hospital, Baghshomal square
Street address - Persian: چهارراه باغشمال, بیمارستان الزهرا
City - English: Tabriz
City - Persian: تبریز
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 41 3553 9161
Mobile:
Fax:
Email: atashkhoii@tbzmed.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Tabriz Medical University
Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز
Full name of responsible person - English: Dr. Simin Atashkhoyi
Full name of responsible person - Persian: دکتر سيمين آتش خوئي
Position - English: Associate Professor, Specialist in Anesthesiology
Position - Persian: متخصص بیهوشی, دانشيار بيهوشي
Latest degree: specialist
Area of specialty/work: 15
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Al Zahra hospital, Baghshomal square
Street address - Persian: چهارراه باغشمال, بیمارستان الزهرا
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5166614766
Phone: +98 41 3553 9161
Mobile: +98 914 114 8861
Fax:
Email: atashkhoii@tbzmed.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Tabriz Medical University Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز Full name of responsible person - English: Dr. Simin Atashkhoyi Full name of responsible person - Persian: دکتر سيمين آتش خوئي Position - English: Associate Professor, Specialist in Anesthesiology Position - Persian: متخصص بیهوشی, دانشيار بيهوشي Latest degree: specialist Area of specialty/work: 015 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Al Zahra hospital, Baghshomal square Street address - Persian: چهارراه باغشمال, بیمارستان الزهرا City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 5166614766 Phone: +98 41 3553 9161 Mobile: +98 914 114 8861 Fax: Email: atashkhoii@tbzmed.ac.ir Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Tabriz medical university
Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز
Full name of responsible person - English: Dr. Simin Atashkhoyi
Full name of responsible person - Persian: دکتر سيمين آتش خوئي
Position - English: Associate Professor, Specialist in anesthesiology
Position - Persian: متخصص بیهوشی, دانشيار بيهوشي
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Al Zahra hospital, Baghshomal square
Street address - Persian: چهارراه باغشمال, بیمارستان الزهرا
City - English: Tabriz
City - Persian: تبریز
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 41 3553 9161
Mobile:
Fax:
Email: atashkhoii@tbzmed.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Tabriz medical university
Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز
Full name of responsible person - English: Dr. Simin Atashkhoyi
Full name of responsible person - Persian: دکتر سيمين آتش خوئي
Position - English: Associate Professor, Specialist in anesthesiology
Position - Persian: متخصص بیهوشی, دانشيار بيهوشي
Latest degree: specialist
Area of specialty/work: 24
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Al Zahra hospital, Baghshomal square
Street address - Persian: چهارراه باغشمال, بیمارستان الزهرا
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5166614766
Phone: +98 41 3553 9161
Mobile: +98 914 114 8861
Fax:
Email: atashkhoii@tbzmed.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Tabriz medical university Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز Full name of responsible person - English: Dr. Simin Atashkhoyi Full name of responsible person - Persian: دکتر سيمين آتش خوئي Position - English: Associate Professor, Specialist in anesthesiology Position - Persian: متخصص بیهوشی, دانشيار بيهوشي Latest degree: specialist Area of specialty/work: 024 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Al Zahra hospital, Baghshomal square Street address - Persian: چهارراه باغشمال, بیمارستان الزهرا City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 5166614766 Phone: +98 41 3553 9161 Mobile: +98 914 114 8861 Fax: Email: atashkhoii@tbzmed.ac.ir Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Tabriz Medical University
Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز
Full name of responsible person - English: Dr. Simin Atashkhoyi
Full name of responsible person - Persian: دکتر سيمين آتش خوئي
Position - English: Associate Professor, Specialist in Anesthesiology
Position - Persian: متخصص بیهوشی, دانشيار بيهوشي
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Al Zahra hospital, Baghshomal square
Street address - Persian: چهارراه باغشمال, بیمارستان الزهرا
City - English: Tabriz
City - Persian: تبریز
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 41 3553 9161
Mobile:
Fax:
Email: atashkhoii@tbzmed.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Tabriz Medical University
Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز
Full name of responsible person - English: Dr. Simin Atashkhoyi
Full name of responsible person - Persian: دکتر سيمين آتش خوئي
Position - English: Associate Professor, Specialist in Anesthesiology
Position - Persian: متخصص بیهوشی, دانشيار بيهوشي
Latest degree: specialist
Area of specialty/work: 24
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Al Zahra hospital, Baghshomal square
Street address - Persian: چهارراه باغشمال, بیمارستان الزهرا
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5166614766
Phone: +98 41 3553 9161
Mobile: +98 914 114 8861
Fax:
Email: atashkhoii@tbzmed.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Tabriz Medical University Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز Full name of responsible person - English: Dr. Simin Atashkhoyi Full name of responsible person - Persian: دکتر سيمين آتش خوئي Position - English: Associate Professor, Specialist in Anesthesiology Position - Persian: متخصص بیهوشی, دانشيار بيهوشي Latest degree: specialist Area of specialty/work: 024 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Al Zahra hospital, Baghshomal square Street address - Persian: چهارراه باغشمال, بیمارستان الزهرا City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 5166614766 Phone: +98 41 3553 9161 Mobile: +98 914 114 8861 Fax: Email: atashkhoii@tbzmed.ac.ir Web page address:
Sharing plan
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
empty
No more information
No more information
empty
اطلاعات بیشتری وجود ندارد
اطلاعات بیشتری وجود ندارد
Protocol summary
Study aim
Effect of Magnesium Sulfate Infusion on Muscle Relaxation after Spinal Anesthesia for Cesarean Delivery
Design
Randomised, double blinded clinical trial, randomisation was promoted by the method of randomly permuted blocks using Rand software
Settings and conduct
The randomized clinical trial study will conducted on 66 women aged between 18 to 40 years old with term singleton pregnancy candidate for elective cesarean section with epidural analgesia at Al-Zahra hospital of Tabriz University in the period of April 6th, 2017 to September 20th, 2017.Prior to surgery, equally patients will be divided to control and study groups. In operation room, epidural analgesia will be induced in L3-4 or L4-5 intervertebral spaces. Subsequent to delivery and umbilicus clamping, in study group 15 milligrams per kilograms’ magnesium sulfate will be infused till end of the operation and in control group same volume of normal saline will be infused.This study will be double blind in which physician and patients are blind to treatment protocols.
Participants/Inclusion and exclusion criteria
Inclusion criteria included term parturient with ASA I or II, 18-40 years age, scheduled for elective cesarean section with spinal anesthesia. Exclusion criteria included parturient who needed emergency cesarean section, had co-existing systemic diseases,any history of psychological disorder, obesity of BMI>35, history of calcium channel blockers use, recent magnesium consumption, contraindication of spinal anesthesia.
Intervention groups
After neonate delivery in the study group, magnesium sulfate (15 mg kg-1 in 100 ml 0.9% saline) was infused over 15 minutes. Then, 15 mg/kg/hr. of magnesium sulfate were infused until the end of the surgery. In the placebo group, the same volume of 0.9% saline was infused
Main outcome variables
Motor Relaxation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT201610037013N14
Registration date:2016-10-11, 1395/07/20
Registration timing:prospective
Last update:2019-07-13, 1398/04/22
Update count:1
Registration date
2016-10-11, 1395/07/20
Registrant information
Name
Simin Atashkhoei
Name of organization / entity
Tabriz University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 41 3333 3806
Email address
atashkhoii@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2017-04-06, 1396/01/17
Expected recruitment end date
2017-09-20, 1396/06/29
Actual recruitment start date
2017-04-06, 1396/01/17
Actual recruitment end date
2017-09-20, 1396/06/29
Trial completion date
2017-09-20, 1396/06/29
Scientific title
Effect of magnesium sulfate infusion on muscle relaxation after spinal anesthesia for cesarean delivery
Public title
Magnesium sulfate effect on quality of epidural analgesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
class I or II in American society of anesthesiology;
aged between 18-40 years old;
term pregnancy;
singleton pregnancy;
candidate for elective cesarean section;
candidate for epidural analgesia.
Exclusion criteria:
emergent cesarean section;
systemic diseases (renal, cardiac, pulmonary, hepatic, neuromuscular and etc.)
mental disorders
body mass index more than 35 kilograms per meter square;
calcium channel blockers usage
recent use of magnesium;
contraindications for epidural analgesia.
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
66
Actual sample size reached:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will promoted by the method of randomly permuted blocks using Rand software (Rand list online).
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will be double blind in which physician and patients are blind to treatment protocols.
Placebo
Used
Assignment
Parallel
Other design features
Sealed envelope method used for patients randomized assignment to study group
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz Medical University
Street address
Vice chancellor for research, Tabriz university of medical sceinces, Daneshgah square
City
Tabriz
Province
East Azarbaijan
Postal code
516614766
Approval date
2016-10-27, 1395/08/06
Ethics committee reference number
IR.TBZMED.REC.1395.647
Health conditions studied
1
Description of health condition studied
Epidural analgesia quality
ICD-10 code
O74.6
ICD-10 code description
Other complications of spinal and epidural anaesthesia during labour and delivery
Primary outcomes
1
Description
Muscle relaxation grade
Timepoint
during operation
Method of measurement
will be evaluated by surgeon
2
Description
patient's comfort grade
Timepoint
during operation
Method of measurement
will be answered by patients
3
Description
patient's analgesia grade
Timepoint
during operation
Method of measurement
verbal numeric scale
Secondary outcomes
1
Description
serum magnesium level
Timepoint
before operation, 24 hours after operation
Method of measurement
laboratory measurement
2
Description
sensory block duration
Timepoint
after surgery
Method of measurement
physical examination
3
Description
motor block duration
Timepoint
after surgery
Method of measurement
physical examination
Intervention groups
1
Description
Study group: 15 milligrams per kilograms’ (approximately 1 gram) magnesium sulfate infusion in 100 milliliters normal saline serum during 15 minutes and subsequently, 15 milligrams per kilograms per hour (approximately 1 gram per hour) infusion till end of the operation.
Category
Treatment - Drugs
2
Description
Control group: Normal saline infusion in same volume of magnesium sulfate infused in study group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al Zahra Women's Hospital
Full name of responsible person
Dr. Simin Atashkhoyi
Street address
Artesh street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3553 9161
Email
info@alzahrahosp.tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz Medical University
Full name of responsible person
Alireza Ostadrahimi
Street address
Vice chancellor for research, Tabriz University of medical sceinces, Daneshgah square
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 5921
Email
info@medfac.tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz Medical University
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
Tabriz Medical University
Full name of responsible person
Dr. Simin Atashkhoyi
Position
Associate Professor, Specialist in Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Medical Education
Street address
Al Zahra hospital, Baghshomal square
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3553 9161
Fax
Email
atashkhoii@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz medical university
Full name of responsible person
Dr. Simin Atashkhoyi
Position
Associate Professor, Specialist in anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Al Zahra hospital, Baghshomal square
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3553 9161
Fax
Email
atashkhoii@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz Medical University
Full name of responsible person
Dr. Simin Atashkhoyi
Position
Associate Professor, Specialist in Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Al Zahra hospital, Baghshomal square
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3553 9161
Fax
Email
atashkhoii@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available