Comparing the effect of Dexmedetomidin with Midazolam-Fentanyl in sedation and analgesia in reduction of anterior dislocation of shoulder joint in acute emergency department of Ahvaz Imam Khomeini and Golestan hospitals
Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
Protocol summary
Objective: comparison the effect of Dexmedetomidin with Midazolam-Fentanyl in sedation and analgesia in reduction of anterior dislocation of shoulder joint.
Design: double center single blind randomized clinical trial
Randomization: Patients will allocate to two equal groups of intervention and control according to table of random numbers.
Participants including major eligibility criteria: this study will conduct on 40 patients with anterior dislocation of shoulder joint in Ahvaz Imam Khomeini and Gholestan hospitals. Main inclusion criteria include age of 18-50 years; having anterior shoulder dislocation without any other trauma; having pain score of 4-10 based on visual analog score in admission time and main exclusion criteria include decrease of level of consciousness; trauma and injury of other limbs; pregnancy; addiction; disability in speaking; allergy to opioids; abnormality in vital signs such as systolic blood pressure below 90 mmHg and respiratory rate below 12 beat in minute.
Main outcome: sedation and analgesia
Intervention: patients in intervention group will receive Dexmedetomidin via intravenous with dosage of 1 micro-gram per kilogram in 10-15 minutes. Patients in control group will receive Midazolam with dosage of 0.1 milligram per kilogram via intravenous with Fentanyl in 2-3 micro-grams per kilogram in 10-15 minutes.
empty
Objective: comparison the effect of Dexmedetomidin with Midazolam-Fentanyl in sedation and analgesia in reduction of anterior dislocation of shoulder joint. Design: double center single blind randomized clinical trial Randomization: Patients will allocate to two equal groups of intervention and control according to table of random numbers. Participants including major eligibility criteria: this study will conduct on 40 patients with anterior dislocation of shoulder joint in Ahvaz Imam Khomeini and Gholestan hospitals. Main inclusion criteria include age of 18-50 years; having anterior shoulder dislocation without any other trauma; having pain score of 4-10 based on visual analog score in admission time and main exclusion criteria include decrease of level of consciousness; trauma and injury of other limbs; pregnancy; addiction; disability in speaking; allergy to opioids; abnormality in vital signs such as systolic blood pressure below 90 mmHg and respiratory rate below 12 beat in minute. Main outcome: sedation and analgesia Intervention: patients in intervention group will receive Dexmedetomidin via intravenous with dosage of 1 micro-gram per kilogram in 10-15 minutes. Patients in control group will receive Midazolam with dosage of 0.1 milligram per kilogram via intravenous with Fentanyl in 2-3 micro-grams per kilogram in 10-15 minutes.
هدف: مقايسه اثر دكسمدتوميدين با ميدازولام فنتانيل در آرام بخشي و بي دردي جااندازي دررفتگي قدامي شانه
طراحي مطالعه: كارآزمايي باليني تصادفي يك سويه كور دو مركزي
تصادفی سازی: بیماران با استفاده از جدول اعداد تصادفی به دو گروه مساوی مداخله و کنترل تقسیم خواهند شد.
شرکت کنندگان شامل شرایط ورود و خروج اصلی شرکت کنندگان: این مطالعه بر روی 40 بیمار با دررفتگی مفصل شانه مراجعه کننده به بیمارستان گلستان و امام شهر اهواز انجام خواهد شد. معیارهای ورود اصلی شامل داشتن سن 50-18 سال؛ داشتن دررفتگي قدامي شانه بدون آسيب تروماتيك همراه؛ داشتن نمره درد 10-4 براساس معیار دیداری درد در بدو پذیرش و معيارهاي خروج اصلی شامل كاهش سطح هوشياري؛ تروما و آسيب همزمان ساير اندام ها؛ حاملگي؛ اعتياد؛ عدم توانايي در صحبت كردن؛ حساسيت دارويي به مخدرها؛ اختلال در علايم حياتي مانند فشار خون زير 90 میلی متر جیوه و تنفس كمتر از 12 ضربه در دقیقه.
متغیر پیامد اصلی: شدت درد و آرامبخشی
مداخلات: بیماران گروه مداخله دکسمدتومیدین وریدی با دوز 1 میکرو گرم بر کیلوگرم در 15-10 دقیقه دریافت خواهند کرد. بیماران گروه کنترل میدازولام وریدی با دوز 0.1 میلی گرم بر کیلوگرم همراه با فنتانیل وریدی با دوز 3-2 میکرو گرم بر کیلوگرم در 15-10 دقیقه دریافت خواهند کرد.
empty
هدف: مقايسه اثر دكسمدتوميدين با ميدازولام فنتانيل در آرام بخشي و بي دردي جااندازي دررفتگي قدامي شانه طراحي مطالعه: كارآزمايي باليني تصادفي يك سويه كور دو مركزي تصادفی سازی: بیماران با استفاده از جدول اعداد تصادفی به دو گروه مساوی مداخله و کنترل تقسیم خواهند شد. شرکت کنندگان شامل شرایط ورود و خروج اصلی شرکت کنندگان: این مطالعه بر روی 40 بیمار با دررفتگی مفصل شانه مراجعه کننده به بیمارستان گلستان و امام شهر اهواز انجام خواهد شد. معیارهای ورود اصلی شامل داشتن سن 50-18 سال؛ داشتن دررفتگي قدامي شانه بدون آسيب تروماتيك همراه؛ داشتن نمره درد 10-4 براساس معیار دیداری درد در بدو پذیرش و معيارهاي خروج اصلی شامل كاهش سطح هوشياري؛ تروما و آسيب همزمان ساير اندام ها؛ حاملگي؛ اعتياد؛ عدم توانايي در صحبت كردن؛ حساسيت دارويي به مخدرها؛ اختلال در علايم حياتي مانند فشار خون زير 90 میلی متر جیوه و تنفس كمتر از 12 ضربه در دقیقه. متغیر پیامد اصلی: شدت درد و آرامبخشی مداخلات: بیماران گروه مداخله دکسمدتومیدین وریدی با دوز 1 میکرو گرم بر کیلوگرم در 15-10 دقیقه دریافت خواهند کرد. بیماران گروه کنترل میدازولام وریدی با دوز 0.1 میلی گرم بر کیلوگرم همراه با فنتانیل وریدی با دوز 3-2 میکرو گرم بر کیلوگرم در 15-10 دقیقه دریافت خواهند کرد.
empty
comparison the effect of Dexmedetomidin with Midazolam-Fentanyl in sedation and analgesia in reduction of anterior dislocation of shoulder joint
comparison the effect of Dexmedetomidin with Midazolam-Fentanyl in sedation and analgesia in reduction of anterior dislocation of shoulder joint
empty
قايسه اثر دكسمدتوميدين با ميدازولام فنتانيل در آرام بخشي و بي دردي جااندازي دررفتگي قدامي شانه
قايسه اثر دكسمدتوميدين با ميدازولام فنتانيل در آرام بخشي و بي دردي جااندازي دررفتگي قدامي شانه
empty
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
empty
کارآزمایی بالینی فاقد گروه کنترل، مبتنی بر جامعه، با گروه های موازی ، دو سویه کور ، تصادفی شده
کارآزمایی بالینی فاقد گروه کنترل، مبتنی بر جامعه، با گروه های موازی ، دو سویه کور ، تصادفی شده
empty
Patients will allocate to two equal groups of intervention and control according to table of random numbers. Participants including major eligibility criteria: this study will conduct on 40 patients with anterior dislocation of shoulder joint in Ahvaz Imam Khomeini and Gholestan hospitals.
Patients will allocate to two equal groups of intervention and control according to table of random numbers. Participants including major eligibility criteria: this study will conduct on 40 patients with anterior dislocation of shoulder joint in Ahvaz Imam Khomeini and Gholestan hospitals.
empty
بیماران با استفاده از جدول اعداد تصادفی به دو گروه مساوی مداخله و کنترل تقسیم خواهند شد. شرکت کنندگان شامل شرایط ورود و خروج اصلی شرکت کنندگان: این مطالعه بر روی 40 بیمار با دررفتگی مفصل شانه مراجعه کننده به بیمارستان گلستان و امام شهر اهواز انجام خواهد شد.
بیماران با استفاده از جدول اعداد تصادفی به دو گروه مساوی مداخله و کنترل تقسیم خواهند شد. شرکت کنندگان شامل شرایط ورود و خروج اصلی شرکت کنندگان: این مطالعه بر روی 40 بیمار با دررفتگی مفصل شانه مراجعه کننده به بیمارستان گلستان و امام شهر اهواز انجام خواهد شد.
empty
age of 18-50 years; having anterior shoulder dislocation without any other trauma; having pain score of 4-10 based on visual analog score in admission time; having consciousness level in a way that has no appropriate verbal response but normal cardiovascular function.
age of 18-50 years; having anterior shoulder dislocation without any other trauma; having pain score of 4-10 based on visual analog score in admission time; having consciousness level in a way that has no appropriate verbal response but normal cardiovascular function.
empty
سن 50-18 سال؛ داشتن دررفتگي قدامي شانه بدون آسيب تروماتيك همراه و بدون سابقه قبلي؛ داشتن درد از 10-4 براساس معیار دیداری درد در بدو پذیرش؛ داشتن سطح هوشياري در حدي كه پاسخ كلامي مناسب نداشته باشد ولي كاركرد قلبي عروقي طبيعي باشد.
سن 50-18 سال؛ داشتن دررفتگي قدامي شانه بدون آسيب تروماتيك همراه و بدون سابقه قبلي؛ داشتن درد از 10-4 براساس معیار دیداری درد در بدو پذیرش؛ داشتن سطح هوشياري در حدي كه پاسخ كلامي مناسب نداشته باشد ولي كاركرد قلبي عروقي طبيعي باشد.
empty
Patients in group I received intravenous dexmedetomidine 1 microgram/kg loading dose followed by 0.2 µg/kg/h. Patients in group II received intervenus midazolam 0.05 mg/kg in combination with 1 µg /kg midazolam-fentanyl for 10-15 minutes.
Patients in group I received intravenous dexmedetomidine 1 microgram/kg loading dose followed by 0.2 µg/kg/h. Patients in group II received intervenus midazolam 0.05 mg/kg in combination with 1 µg /kg midazolam-fentanyl for 10-15 minutes.
empty
بیماران گروه I دگزامتامینیدین تزریق داخل وریدی 1 میکروگرم بر کیلوگرم به ازای هر کیلوگرم وزن بدن و سپس 0.2 میکروگرم بر کیلوگرم ساعت دریافت کردند. بیماران گروه دوم مداخله میادازولام 0.05 میلی گرم / کیلوگرم را در ترکیب با 1 میکروگرم در کیلوگرم میدازولام فنتانیل به مدت 10-15 دقیقه دریافت کردند.
بیماران گروه I دگزامتامینیدین تزریق داخل وریدی 1 میکروگرم بر کیلوگرم به ازای هر کیلوگرم وزن بدن و سپس 0.2 میکروگرم بر کیلوگرم ساعت دریافت کردند. بیماران گروه دوم مداخله میادازولام 0.05 میلی گرم / کیلوگرم را در ترکیب با 1 میکروگرم در کیلوگرم میدازولام فنتانیل به مدت 10-15 دقیقه دریافت کردند.
empty
sedation and analgesia
sedation and analgesia
empty
شدت درد و آرامبخشی
شدت درد و آرامبخشی
General information
Single blinded
Double blinded
singldoubl
1
1
1
1
1
1
1
1
2016-05-21, 1395/03/01
2019-01-10, 1397/10/20
20162019-0501-2110 00:00:00
age of 18-50 years
having anterior shoulder dislocation without any other trauma
having pain score of 4-10 based on visual analog score in admission time
having consciousness level in a way that has no appropriate verbal response but normal cardiovascular function
age of 18-50 years having anterior shoulder dislocation without any other trauma having pain score of 4-10 based on visual analog score in admission time having consciousness level in a way that has no appropriate verbal response but normal cardiovascular function
سن 50-18 سال؛ داشتن دررفتگي قدامي شانه بدون آسيب تروماتيك همراه و بدون سابقه قبلي
داشتن درد از 10-4 براساس معیار دیداری درد در بدو پذیرش
داشتن سطح هوشياري در حدي كه پاسخ كلامي مناسب نداشته باشد ولي كاركرد قلبي عروقي طبيعي باشد
سن 50-18 سال؛ داشتن دررفتگي قدامي شانه بدون آسيب تروماتيك همراه و بدون سابقه قبلي داشتن درد از 10-4 براساس معیار دیداری درد در بدو پذیرش داشتن سطح هوشياري در حدي كه پاسخ كلامي مناسب نداشته باشد ولي كاركرد قلبي عروقي طبيعي باشد
decrease of level of consciousness
trauma and injury of other limbs
pregnancy
addiction
disability in speaking
lack of cooperation
allergy to opioids
abnormality in vital signs such as systolic blood pressure below 90 mmHg and respiratory rate below 12 beat in minute
decrease of level of consciousness trauma and injury of other limbs pregnancy addiction disability in speaking lack of cooperation allergy to opioids abnormality in vital signs such as systolic blood pressure below 90 mmHg and respiratory rate below 12 beat in minute
كاهش هوشياري
روما و آسيب همزمان ساير اندام ها
حاملگي
اعتياد
عدم توانايي در صحبت كردن
عدم تمايل به همكاري
حساسيت دارويي به مخدرها
اختلال در علايم حياتي مانند فشار خون زير 90 میلی متر جیوه و تنفس كمتر از 12 ضربه در دقیقه
كاهش هوشياري روما و آسيب همزمان ساير اندام ها حاملگي اعتياد عدم توانايي در صحبت كردن عدم تمايل به همكاري حساسيت دارويي به مخدرها اختلال در علايم حياتي مانند فشار خون زير 90 میلی متر جیوه و تنفس كمتر از 12 ضربه در دقیقه
empty
Patients will be divided into two equal groups of intervention and control using random numbers.
Patients will be divided into two equal groups of intervention and control using random numbers.
empty
بیماران با استفاده از جدول اعداد تصادفی به دو گروه مساوی مداخله و کنترل تقسیم خواهند شد.
بیماران با استفاده از جدول اعداد تصادفی به دو گروه مساوی مداخله و کنترل تقسیم خواهند شد.
empty
After randomization, the intervention was performed in a double-blind manner in which the interventional physician, the patients assessing the pain of the patients, as well as the patients, did not know the group in which they were located. The only second-person study that did not interfere with the collection of data was observing the study, was not blind.
After randomization, the intervention was performed in a double-blind manner in which the interventional physician, the patients assessing the pain of the patients, as well as the patients, did not know the group in which they were located. The only second-person study that did not interfere with the collection of data was observing the study, was not blind.
empty
پس از تقسیم تصادفی بیماران، مداخله به صورت دو سو کور به شکلی انجام گرفت که پزشک مداخله گر، مسولین ارزیابی درد بیماران و همچنین بیماران اطلاعی از گروهی که در آن قرار گرفته بودند نداشتند. تنها شخص دوم مطالعه که دخالتی در جمع آوری دیتاها نداشت و ناظر بر مطالعه بود، کور نشده بود.
پس از تقسیم تصادفی بیماران، مداخله به صورت دو سو کور به شکلی انجام گرفت که پزشک مداخله گر، مسولین ارزیابی درد بیماران و همچنین بیماران اطلاعی از گروهی که در آن قرار گرفته بودند نداشتند. تنها شخص دوم مطالعه که دخالتی در جمع آوری دیتاها نداشت و ناظر بر مطالعه بود، کور نشده بود.
Recruitment centers
#1
Name of recruitment center - English: Ahvaz Imam Khomeini hospital
Name of recruitment center - Persian: یمارستان امام خمینی اهواز
Full name of responsible person - English: Ali Delirrooy Fard
Full name of responsible person - Persian: علی دلیر روی فرد
Street address - English: Emam Khomeini hospital, Ahvaz, Khuzestan
Street address - Persian: خوزستان، اهواز، بیمارستان امام خمینی اهواز
City - English: Ahvaz
City - Persian: اهواز
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Ahvaz Imam Khomeini hospital
Name of recruitment center - Persian: یمارستان امام خمینی اهواز
Full name of responsible person - English: Ali Delirrooy Fard
Full name of responsible person - Persian: علی دلیر روی فرد
Street address - English: Emam Khomeini hospital, Ahvaz, Khuzestan
Street address - Persian: خوزستان، اهواز، بیمارستان امام خمینی اهواز
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 1579461357
Phone: +98 61 3264 2936
Fax:
Email: adelir1982@gmail.com
Web page address:
Name of recruitment center - English: Ahvaz Imam Khomeini hospital Name of recruitment center - Persian: یمارستان امام خمینی اهواز Full name of responsible person - English: Ali Delirrooy Fard Full name of responsible person - Persian: علی دلیر روی فرد Street address - English: Emam Khomeini hospital, Ahvaz, Khuzestan Street address - Persian: خوزستان، اهواز، بیمارستان امام خمینی اهواز City - English: Ahvaz City - Persian: اهواز Province: Khouzestan Country: Iran (Islamic Republic of) Postal code: 1579461357 Phone: +98 61 3264 2936 Fax: Email: adelir1982@gmail.com Web page address:
#2
Name of recruitment center - English: Ahvaz Golestan hospital
Name of recruitment center - Persian: بیمارستان گلستان اهواز
Full name of responsible person - English: Ali Delirrooy Fard
Full name of responsible person - Persian: علی دلیر روی فرد
Street address - English: Golestan hospital, Golestan road, Ahvaz, Khuzestan
Street address - Persian: خوزستان، اهواز، خیابان گلستان، بیمارستان گلستان اهواز
City - English: Ahvaz
City - Persian: اهواز
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Ahvaz Golestan hospital
Name of recruitment center - Persian: بیمارستان گلستان اهواز
Full name of responsible person - English: Ali Delirrooy Fard
Full name of responsible person - Persian: علی دلیر روی فرد
Street address - English: Golestan hospital, Golestan road, Ahvaz, Khuzestan
Street address - Persian: خوزستان، اهواز، خیابان گلستان، بیمارستان گلستان اهواز
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 1579461357
Phone: +98 61 3264 2936
Fax:
Email: adelir1982@gmail.com
Web page address:
Name of recruitment center - English: Ahvaz Golestan hospital Name of recruitment center - Persian: بیمارستان گلستان اهواز Full name of responsible person - English: Ali Delirrooy Fard Full name of responsible person - Persian: علی دلیر روی فرد Street address - English: Golestan hospital, Golestan road, Ahvaz, Khuzestan Street address - Persian: خوزستان، اهواز، خیابان گلستان، بیمارستان گلستان اهواز City - English: Ahvaz City - Persian: اهواز Province: Khouzestan Country: Iran (Islamic Republic of) Postal code: 1579461357 Phone: +98 61 3264 2936 Fax: Email: adelir1982@gmail.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Ahwaz Judishapur University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی جندی شاپور اهواز
Full name of responsible person - English: Ali Delirrooy Fard
Full name of responsible person - Persian: علی دلیر روی فرد
Street address - English: Emergency department of Imam Khomeyni hospital
Street address - Persian: بخش اورژانس بیمارستان امام خمینی
City - English: Ahvaz
City - Persian: اهواز
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Ahwaz Judishapur University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی جندی شاپور اهواز
Full name of responsible person - English: Ali Delirrooy Fard
Full name of responsible person - Persian: علی دلیر روی فرد
Street address - English: Emergency department of Imam Khomeyni hospital
Street address - Persian: بخش اورژانس بیمارستان امام خمینی
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 1579461357
Phone: +98 61 3264 2936
Fax:
Email: adelir1982@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Ahwaz Judishapur University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی جندی شاپور اهواز Full name of responsible person - English: Ali Delirrooy Fard Full name of responsible person - Persian: علی دلیر روی فرد Street address - English: Emergency department of Imam Khomeyni hospital Street address - Persian: بخش اورژانس بیمارستان امام خمینی City - English: Ahvaz City - Persian: اهواز Province: Khouzestan Country: Iran (Islamic Republic of) Postal code: 1579461357 Phone: +98 61 3264 2936 Fax: Email: adelir1982@gmail.com 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: Ahvaz Jundishapur University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی جندی شاپور اهواز
Full name of responsible person - English: Seyyed Javad Maleki
Full name of responsible person - Persian: سید جواد ملکی
Position - English: Resident of emergency medicine
Position - Persian: دستیار تخصصی طب اورزانس
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Imam Khomeini hospital, Azadegan road, Ahvaz, Khuzestan
Street address - Persian: خوزستان، اهواز، خیابان آزادگان، بیمارستان امام خمینی
City - English: Ahvaz
City - Persian: اهواز
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 6135715794
Phone: +98 613738383
Mobile: +98 915 571 0174
Fax: +98 613361544
Email: dr.sjmh.1987m@gmail.commaleki.sj@ajums.ac.ir
Web page address: search@ajums.ac.ir
contact.organization_id:
Name of organization / entity - English: Ahvaz Jundishapur University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی جندی شاپور اهواز
Full name of responsible person - English: Seyyed Javad Maleki
Full name of responsible person - Persian: سید جواد ملکی
Position - English: Resident of emergency medicine
Position - Persian: دستیار تخصصی طب اورزانس
Latest degree: specialist
Area of specialty/work: 57
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Imam Khomeini hospital, Azadegan road, Ahvaz, Khuzestan
Street address - Persian: خوزستان، اهواز، خیابان آزادگان، بیمارستان امام خمینی
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 6135715794
Phone: +98 613738383
Mobile: +98 915 571 0174
Fax:
Email: maleki.sj@ajums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Ahvaz Jundishapur University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی جندی شاپور اهواز Full name of responsible person - English: Seyyed Javad Maleki Full name of responsible person - Persian: سید جواد ملکی Position - English: Resident of emergency medicine Position - Persian: دستیار تخصصی طب اورزانس Latest degree: specialist Area of specialty/work: 057 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Imam Khomeini hospital, Azadegan road, Ahvaz, Khuzestan Street address - Persian: خوزستان، اهواز، خیابان آزادگان، بیمارستان امام خمینی City - English: Ahvaz City - Persian: اهواز Province: Khouzestan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 6135715794 Phone: +98 613738383 Mobile: +98 915 571 0174 Fax: +98 613361544 Email: dr.sjmh.1987m@gmail.commaleki.sjmaleki.sj@ajums.ac.ir Web page address: search@ajums.ac.ir
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Ahvaz Jundishapur University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی جندی شاپور اهواز
Full name of responsible person - English: Ali Delirrooy Fard
Full name of responsible person - Persian: علی دلیر روی فرد
Position - English: Assistant professor
Position - Persian: استادیار
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Imam Khomeini hospital, Azadegan road, Ahvaz, Khuzestan
Street address - Persian: خوزستان، اهواز، خیابان آزاداگان، بیمارستان امام خمینی
City - English: Ahvaz
City - Persian: اهواز
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 6135715794
Phone: +98 613738383
Mobile: +91 73159418
Fax: +98 613361544
Email: a delir1982@gmail.comdelirrooyfard-a@ajums.ac.ir
Web page address: search.@ajums.ac.ir
contact.organization_id:
Name of organization / entity - English: Ahvaz Jundishapur University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی جندی شاپور اهواز
Full name of responsible person - English: Ali Delirrooy Fard
Full name of responsible person - Persian: علی دلیر روی فرد
Position - English: Assistant professor
Position - Persian: استادیار
Latest degree: specialist
Area of specialty/work: 57
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Imam Khomeini hospital, Azadegan road, Ahvaz, Khuzestan
Street address - Persian: خوزستان، اهواز، خیابان آزاداگان، بیمارستان امام خمینی
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1579461357
Phone: +98 61 3264 2936
Mobile: +91 73159418
Fax:
Email: adelir1982@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Ahvaz Jundishapur University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی جندی شاپور اهواز Full name of responsible person - English: Ali Delirrooy Fard Full name of responsible person - Persian: علی دلیر روی فرد Position - English: Assistant professor Position - Persian: استادیار Latest degree: specialist Area of specialty/work: 057 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Imam Khomeini hospital, Azadegan road, Ahvaz, Khuzestan Street address - Persian: خوزستان، اهواز، خیابان آزاداگان، بیمارستان امام خمینی City - English: Ahvaz City - Persian: اهواز Province: Khouzestan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 61357157941579461357 Phone: +98 61373838361 3264 2936 Mobile: +91 73159418 Fax: +98 613361544 Email: a delir1982adelir1982@gmail.comdelirrooyfard-a@ajums.ac.irgmail.com Web page address: search.@ajums.ac.ir
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Ahvaz Jundishapur University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی جندی شاپور اهواز
Full name of responsible person - English: Seyyed Javad Maleki
Full name of responsible person - Persian: سید جواد ملکی
Position - English: Resident of emergency medince
Position - Persian: دستیار تخصصی طب اورژانس
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Imam Khomeini hospital, Ahvaz, Khuzestan
Street address - Persian: خوزستان، اهواز، بیمارستان امام خمینی اهواز
City - English: Ahvaz
City - Persian: اهواز
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 6135715794
Phone: +98 613738383
Mobile: +98 915 571 0174
Fax: +98 613361544
Email: dr.sjmh.1987m@gmail.commaleki.sj@ajums.ac.ir
Web page address: search@ajums.ac.ir
contact.organization_id:
Name of organization / entity - English: Ahvaz Jundishapur University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی جندی شاپور اهواز
Full name of responsible person - English: Seyyed Javad Maleki
Full name of responsible person - Persian: سید جواد ملکی
Position - English: Resident of emergency medince
Position - Persian: دستیار تخصصی طب اورژانس
Latest degree: specialist
Area of specialty/work: 57
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Imam Khomeini hospital, Ahvaz, Khuzestan
Street address - Persian: خوزستان، اهواز، بیمارستان امام خمینی اهواز
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 6135715794
Phone: +98 613738383
Mobile: +98 915 571 0174
Fax:
Email: maleki.sj@ajums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Ahvaz Jundishapur University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی جندی شاپور اهواز Full name of responsible person - English: Seyyed Javad Maleki Full name of responsible person - Persian: سید جواد ملکی Position - English: Resident of emergency medince Position - Persian: دستیار تخصصی طب اورژانس Latest degree: specialist Area of specialty/work: 057 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Imam Khomeini hospital, Ahvaz, Khuzestan Street address - Persian: خوزستان، اهواز، بیمارستان امام خمینی اهواز City - English: Ahvaz City - Persian: اهواز Province: Khouzestan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 6135715794 Phone: +98 613738383 Mobile: +98 915 571 0174 Fax: +98 613361544 Email: dr.sjmh.1987m@gmail.commaleki.sjmaleki.sj@ajums.ac.ir Web page address: search@ajums.ac.ir
Sharing plan
undecided
undecided
no
no
no
no
undecided
undecided
na
na
na
na
na
na
empty
No more information
No more information
empty
اطلاعات بیشتری وجود ندارد
اطلاعات بیشتری وجود ندارد
Protocol summary
Study aim
comparison the effect of Dexmedetomidin with Midazolam-Fentanyl in sedation and analgesia in reduction of anterior dislocation of shoulder joint
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
Patients will allocate to two equal groups of intervention and control according to table of random numbers. Participants including major eligibility criteria: this study will conduct on 40 patients with anterior dislocation of shoulder joint in Ahvaz Imam Khomeini and Gholestan hospitals.
Participants/Inclusion and exclusion criteria
age of 18-50 years; having anterior shoulder dislocation without any other trauma; having pain score of 4-10 based on visual analog score in admission time; having consciousness level in a way that has no appropriate verbal response but normal cardiovascular function.
Intervention groups
Patients in group I received intravenous dexmedetomidine 1 microgram/kg loading dose followed by 0.2 µg/kg/h. Patients in group II received intervenus midazolam 0.05 mg/kg in combination with 1 µg /kg midazolam-fentanyl for 10-15 minutes.
Main outcome variables
sedation and analgesia
General information
Reason for update
Acronym
have no acronym
IRCT registration information
IRCT registration number:IRCT2016021726611N1
Registration date:2016-07-11, 1395/04/21
Registration timing:registered_while_recruiting
Last update:2018-12-08, 1397/09/17
Update count:1
Registration date
2016-07-11, 1395/04/21
Registrant information
Name
Seyyed Javad Maleki
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 613738383
Email address
maleki.sj@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahwaz Judishapur University of Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2019-01-10, 1397/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Dexmedetomidin with Midazolam-Fentanyl in sedation and analgesia in reduction of anterior dislocation of shoulder joint in acute emergency department of Ahvaz Imam Khomeini and Golestan hospitals
Public title
Comparing the effect of Dexmedetomidin with Midazolam-Fentanyl in sedation and analgesia in reduction of anterior dislocation of shoulder joint
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age of 18-50 years
having anterior shoulder dislocation without any other trauma
having pain score of 4-10 based on visual analog score in admission time
having consciousness level in a way that has no appropriate verbal response but normal cardiovascular function
Exclusion criteria:
decrease of level of consciousness
trauma and injury of other limbs
pregnancy
addiction
disability in speaking
lack of cooperation
allergy to opioids
abnormality in vital signs such as systolic blood pressure below 90 mmHg and respiratory rate below 12 beat in minute
Age
From 18 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into two equal groups of intervention and control using random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
After randomization, the intervention was performed in a double-blind manner in which the interventional physician, the patients assessing the pain of the patients, as well as the patients, did not know the group in which they were located. The only second-person study that did not interfere with the collection of data was observing the study, was not blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan road, Ahvaz, Khuzestan
City
Ahvaz
Province
Khouzestan
Postal code
00986135715794
Approval date
2015-09-19, 1394/06/28
Ethics committee reference number
IR.AJUMS.REC.1394.361
Health conditions studied
1
Description of health condition studied
Dislocation of acromioclavicular joint
ICD-10 code
S43.1
ICD-10 code description
Dislocation of acromioclavicular joint
Primary outcomes
1
Description
Sedation and analgesia
Timepoint
10 minutes after intervention
Method of measurement
Questionnaire and visual analog sore
Secondary outcomes
1
Description
Side effects
Timepoint
10-15 minutes after intervention
Method of measurement
Researcher-made questionnaire
Intervention groups
1
Description
Patients in intervention group will receive Dexmedetomidin via intravenous with dosage of 1 micro-gram per kilogram in 10-15 minutes.
Category
Treatment - Drugs
2
Description
Patients in control group will receive Midazolam with dosage of 0.1 milligram per kilogram via intravenous with Fentanyl in 2-3 micro-grams per kilogram in 10-15 minutes