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Protocol summary
Comparison of the effect of hyoscine and EMLA cream on Catheter related bladder discomfort in patients undergoing non-urological surgery
Comparison of the effect of hyoscine and EMLA cream on Catheter related bladder discomfort in non-urological surgery
Comparison of the effect of hyoscine and EMLA cream on Catheter related bladder discomfort in patients undergoing non-urological surgery
کارآزمایی بالینی دارای دو گروه مداخله، با گروه های موازی ، سه سویه کور ، تصادفی شده، فاز 3 بر روی ۷۰ بیمار.
کارآزمایی بالینی دارای دو گروه مداخله، با گروه های موازی ، سه سویه کور ، تصادفی شده، فاز 3 بر روی 105 بیمار.
کارآزمایی بالینی دارای دو گروه مداخله، با گروه های موازی ، سه سویه کور ، تصادفی شده، فاز 3 بر روی ۷۰105 بیمار.
پس از اخذ رضایت نامه کتبی از واحدهای پژوهش با استفاده از بلوک های جایگشتی چهارتایی به دو گروه تخصیص داده خواهند شد شرکت کنندگان،ارزیابان پیامد و تحلیلگر آماری از اینکه بیمار در کدام گروه مطالعه قرار دارد مطلع نیستند.در بیمارستان بهلول گنابادی،مطابق چک لیست بررسی فراوانی و شدت CRBD در لحظه ورود بیمار به ریکاوری و 1، 3 و 6 ساعت پس از پایان بیهوشی ثبت می شود.
پس از اخذ رضایت نامه کتبی از واحدهای پژوهش با استفاده از بلوک های جایگشتی سه تایی به سه گروه تخصیص داده خواهند شد شرکت کنندگان،ارزیابان پیامد و تحلیلگر آماری از اینکه بیمار در کدام گروه مطالعه قرار دارد مطلع نیستند.در بیمارستان بهلول گنابادی،مطابق چک لیست بررسی فراوانی و شدت CRBD در یک، دو، سه و چهار ساعت پس از پایان بیهوشی در سه گروه ثبت می شود.
پس از اخذ رضایت نامه کتبی از واحدهای پژوهش با استفاده از بلوک های جایگشتی چهارتاییسه تایی به دوسه گروه تخصیص داده خواهند شد شرکت کنندگان،ارزیابان پیامد و تحلیلگر آماری از اینکه بیمار در کدام گروه مطالعه قرار دارد مطلع نیستند.در بیمارستان بهلول گنابادی،مطابق چک لیست بررسی فراوانی و شدت CRBD در لحظه ورود بیمار به ریکاورییک، دو، سه و 1، 3 و 6چهار ساعت پس از پایان بیهوشی در سه گروه ثبت می شود.
Having ASA class 1 or 2 , 18 to 60 years old, Elective surgery, general anesthesia and requires urinary catheterization, No history of bladder obstruction, overactive bladder, severe kidney and liver diseases, chronic pain, cerebrovascular disorders, cardiovascular diseases, psychosis, neurological bladder. Non-urological surgeries. No history of allergy to lidocaine or prilocaine and hyoscine, No cardiac dysrhythmia. No obvious cognitive impairment
Do not take sedatives for a long time. No kidney or liver failure. No history of drug use. No untreated glaucoma, active bleeding, Paralytic ileus, chronic lung disease and secondary tachycardia due to heart failure. Medications used before and during anesthesia should be the same.
Unwillingness to cooperate. Patients should also undergo urological surgery during the operation.
Any effective intervention or medication in addition to medications used in the routine anesthesia process
Having ASA class 1 or 2 , 18 to 60 years old, Elective surgery, general anesthesia and requires urinary catheterization, No history of bladder obstruction, overactive bladder, kidney and liver diseases, chronic pain, cerebrovascular disorders, cardiovascular diseases, psychosis, neurological bladder. Non-urological surgeries. No history of allergy to lidocaine or prilocaine and hyoscine, No cardiac dysrhythmia. No obvious cognitive impairment
Do not take sedatives for a long time. No kidney or liver failure. No history of drug use. No untreated glaucoma, active bleeding, Paralytic ileus, chronic lung disease and secondary tachycardia due to heart failure. Medications used before and during anesthesia should be the same.
Unwillingness to cooperate. Patients should also undergo urological surgery during the operation.
Any effective intervention or medication in addition to medications used in the routine anesthesia process
Having ASA class 1 or 2 , 18 to 60 years old, Elective surgery, general anesthesia and requires urinary catheterization, No history of bladder obstruction, overactive bladder, severe kidney and liver diseases, chronic pain, cerebrovascular disorders, cardiovascular diseases, psychosis, neurological bladder. Non-urological surgeries. No history of allergy to lidocaine or prilocaine and hyoscine, No cardiac dysrhythmia. No obvious cognitive impairment Do not take sedatives for a long time. No kidney or liver failure. No history of drug use. No untreated glaucoma, active bleeding, Paralytic ileus, chronic lung disease and secondary tachycardia due to heart failure. Medications used before and during anesthesia should be the same. Unwillingness to cooperate. Patients should also undergo urological surgery during the operation. Any effective intervention or medication in addition to medications used in the routine anesthesia process
group 1: Hyoscine N-butyl bromide, at a dose of 20 mg intravenously within one minute before extubating ,group 2: 5 g of EMLA cream made in Iran, applicating before placing a urinary catheter for a patient
group 1: Hyoscine N-butyl bromide, at a dose of 20 mg intravenously within one minute before extubating. group 2, 5 g of EMLA cream and group 3 (control): 5 g of Lidocaine jell, both of these is made in Iran, applicating before placing a urinary catheter for a patient
group 1: Hyoscine N-butyl bromide, at a dose of 20 mg intravenously within one minute before extubating ,. group 2:, 5 g of EMLA cream and group 3 (control): 5 g of Lidocaine jell, both of these is made in Iran, applicating before placing a urinary catheter for a patient
گروه 1: هیوسین ان - بوتیل بروماید ساخت کشور ایران، شرکت اکسیر، با دوز 20 میلی گرم از طریق راه وریدی طی یک دقیقه قبل از اکستوبیشن بیمار
گروه 2: 5 گرم کرم ماینولا ساخت کشور ایران، شرکت ایران دارو قبل از قرار دادن سوند ادراری برای بیمار
گروه 1: هیوسین ان - بوتیل بروماید ساخت کشور ایران، شرکت اکسیر، با دوز 20 میلی گرم از طریق راه وریدی طی یک دقیقه قبل از اکستوبیشن بیمار
گروه 2: 5 گرم کرم ماینولا ساخت کشور ایران، شرکت ایران دارو قبل از قرار دادن سوند ادراری برای بیمار
گروه 3(کنترل): 2-5 گرم ژل لیدوکائین 2% ساخت کشور ایران، شرکت ایران دارو قبل از قرار دادن سوند ادراری برای بیمار
گروه 1: هیوسین ان - بوتیل بروماید ساخت کشور ایران، شرکت اکسیر، با دوز 20 میلی گرم از طریق راه وریدی طی یک دقیقه قبل از اکستوبیشن بیمار گروه 2: 5 گرم کرم ماینولا ساخت کشور ایران، شرکت ایران دارو قبل از قرار دادن سوند ادراری برای بیمار گروه 3(کنترل): 2-5 گرم ژل لیدوکائین 2% ساخت کشور ایران، شرکت ایران دارو قبل از قرار دادن سوند ادراری برای بیمار
General information
Used
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Adding control group to study, changing the measurement time and modifying randomization mode and sample size
Adding control group to study, changing the measurement time and modifying randomization mode and sample size
empty
اضافه نمودن گروه کنترل به مطالعه، تغییر زمان اندازه گیری ها، اصلاح نحوه تصادفی سازی و اصلاح حجم نمونه
اضافه نمودن گروه کنترل به مطالعه، تغییر زمان اندازه گیری ها، اصلاح نحوه تصادفی سازی و اصلاح حجم نمونه
After obtaining written consent from the participants, The patients were selected through purposive sampling method and were randomly assigned to control and intervention groups based on the permutation blocks method. To do this, the letter A and B will be considered for the intervention and control groups, respectively. Possible modes in permutation blocks method are six modes include (AABB, BBAA, ABAB, BABA, ABBA, and BAAB). Each mode will be written on a card and the cards will be assigned the number one to six. Then a mode is selected by throwing the dice. Based on selected mode, patients will be divided into two groups. This process will continue until the sample size is completed.
After obtaining written consent from the participants, the patients were selected through purposive sampling method and were randomly assigned to control and intervention groups based on the permutation blocks method. To do this, the letter C, B and A will be considered for the 2% lidocaine gel (control group), EMLA and Hyoscine + lidocaine groups, respectively. Possible modes in permutation blocks method are six modes include (BCA, ACB, ABC, BAC, CBA, and CAB). Each mode will be written on a card and the cards will be assigned the number one to six. Then 35 mode is selected by using a table of random numbers, 35 numbers between 1 and 6 will be selected. The resulting blocks will be listed in order. Then, based on the list, the selected patients are divided into three groups. In order to homogenize the gender, a separate list is prepared for each of those.
After obtaining written consent from the participants, Thethe patients were selected through purposive sampling method and were randomly assigned to control and intervention groups based on the permutation blocks method. To do this, the letter AC, B and BA will be considered for the intervention2% lidocaine gel (control group), EMLA and controlHyoscine + lidocaine groups, respectively. Possible modes in permutation blocks method are six modes include (AABBBCA, BBAAACB, ABABABC, BABABAC, ABBACBA, and BAABCAB). Each mode will be written on a card and the cards will be assigned the number one to six. Then a35 mode is selected by throwing the dice. Based on selected modeusing a table of random numbers, patients35 numbers between 1 and 6 will be selected. The resulting blocks will be listed in order. Then, based on the list, the selected patients are divided into twothree groups. This process will continue untilIn order to homogenize the sample sizegender, a separate list is completedprepared for each of those.
پس از اخذ رضایت نامه کتبی از واحدهای پژوهش با استفاده از بلوک های جایگشتی چهارتایی به دو گروه تخصیص داده خواهند شد به این شکل که برای گروه مداخله استفاده ازهیوسین حرف A و برای گروه استفاده از کرم املا حرف B در نظر گرفته خواهد شد. حالت های ممکن در بلوک چهارتایی شش حالت شامل AABB, BBAA, ABAB, BABA, ABBA, BAAB است که هر حالت روی یک کارت نوشته خواهد شد و به کارت ها شماره یک تا شش تخصیص داده خواهد شد سپس با استفاده از تاس از شش حالت ممکن یکی انتخاب و براساس آن بیماران انتخابی به دو گروه تقسیم خواهند شد. این پروسه تا تکمیل حجم نمونه ادامه خواهد یافت.
پس از اخذ رضایت نامه کتبی از واحدهای پژوهش با استفاده از بلوک های جایگشتی سه تایی به سه گروه تخصیص داده خواهند شد به این شکل که برای گروه ژل لیدوکائین (کنترل) حرف C، برای گروه استفاده از کرم املا حرف B و برای گروه مداخله هیوسین و لیدوکائین حرف A در نظر گرفته خواهد شد. حالت های ممکن در بلوک سه تایی شش حالت شامل BCA, ACB, ABC, BAC, CBA, CAB است که هر حالت روی یک کارت نوشته خواهد شد و به کارت ها شماره یک تا شش تخصیص داده خواهد شد سپس با استفاده جدول اعداد تصادفی 35 عدد بین 6-1 انتخاب خواهند شد و بلوکهای متناظر با آنها به ترتیب لیست خواهند شد سپس براساس لیست بیماران انتخابی به سه گروه تقسیم خواهند شد. جهت همگن سازی جنس برای هر جنس لیست جداگانه ای تهیه خواهد شد..
پس از اخذ رضایت نامه کتبی از واحدهای پژوهش با استفاده از بلوک های جایگشتی چهارتاییسه تایی به دوسه گروه تخصیص داده خواهند شد به این شکل که برای گروه مداخله استفاده ازهیوسینژل لیدوکائین (کنترل) حرف A وC، برای گروه استفاده از کرم املا حرف B و برای گروه مداخله هیوسین و لیدوکائین حرف A در نظر گرفته خواهد شد. حالت های ممکن در بلوک چهارتاییسه تایی شش حالت شامل AABBBCA, BBAAACB, ABABABC, BABABAC, ABBACBA, BAABCAB است که هر حالت روی یک کارت نوشته خواهد شد و به کارت ها شماره یک تا شش تخصیص داده خواهد شد سپس با استفاده از تاس از شش حالت ممکن یکیجدول اعداد تصادفی 35 عدد بین 6-1 انتخاب خواهند شد و بلوکهای متناظر با آنها به ترتیب لیست خواهند شد سپس براساس آنلیست بیماران انتخابی به دوسه گروه تقسیم خواهند شد. این پروسه تا تکمیل حجم نمونه ادامهجهت همگن سازی جنس برای هر جنس لیست جداگانه ای تهیه خواهد یافتشد..
Prior to anesthesia and allocation to groups, for participants who meet the inclusion criteria will be described control and intervention groups. The participants will be explained that they will allocate into intervention or control groups. At the end of the study, they are informed about their group.
The evaluator of primary (CRBD) and secondary outcomes (severity of CRBD) will be a person (Apart from the main researchers) who does not know the patient is in the intervention or control groups.
One and two will assign to intervention and control groups, respectively. Therefore, the statistical analyst will not aware of the study groups and only will know the groups as a code.
Prior to anesthesia and allocation to groups, for participants who meet the inclusion criteria will be described control and two intervention groups. The participants will be explained that they will allocate into two interventions or control groups. At the end of the study, they are informed about their group.
The evaluator of primary (CRBD) and secondary outcomes (severity of CRBD) will be a person (Apart from the main researchers) who does not know the patient is in the intervention or control groups.
One, two and three will assign to two interventions and control groups, respectively. Therefore, the statistical analyst will not aware of the study groups and only will know the groups as a code.
Prior to anesthesia and allocation to groups, for participants who meet the inclusion criteria will be described control and two intervention groups. The participants will be explained that they will allocate into interventiontwo interventions or control groups. At the end of the study, they are informed about their group. The evaluator of primary (CRBD) and secondary outcomes (severity of CRBD) will be a person (Apart from the main researchers) who does not know the patient is in the intervention or control groups. One, two and twothree will assign to interventiontwo interventions and control groups, respectively. Therefore, the statistical analyst will not aware of the study groups and only will know the groups as a code.
به شرکت کنندگان در مطالعه که واجد معیارهای ورود باشند قبل از بیهوشی و تخصیص دادن به گروه ها توسط پژوهشگر اصلی در مورد گروه کنترل و مداخله توضیح داده خواهد شد و گفته خواهد شد که در یکی از این دو گروه قرار خواهند گرفت و در پایان مطالعه از گروه خود مطلع خواهندشد.
ارزیابان پیامد اصلی (شیوع CRBD) و ثانوی مطالعه (شدت CRBD)، کمک پژوهشگری خواهند بود که اطلاع ندارد بیمار مورد ارزیابی در کدام گروه مطالعه قرار دارد.
به گروه مداخله عدد یک و به گروه کنترل عدد دو اختصاص داده خواهد شد و تحلیلگر آماری از گروه های مطالعه مطلع نبوده و فقط بصورت کد، گروه ها را خواهد شناخت.
به شرکت کنندگان در مطالعه که واجد معیارهای ورود باشند قبل از بیهوشی و تخصیص دادن به گروه ها توسط پژوهشگر اصلی در مورد گروه کنترل و دو گروه مداخله توضیح داده خواهد شد و گفته خواهد شد که در یکی از این سه گروه قرار خواهند گرفت و در پایان مطالعه از گروه خود مطلع خواهندشد.
ارزیابان پیامد اصلی (شیوع CRBD) و ثانوی مطالعه (شدت CRBD)، کمک پژوهشگری خواهند بود که اطلاع ندارد بیمار مورد ارزیابی در کدام گروه مطالعه قرار دارد.
به گروه های مداخله به ترتیب عدد یک و دو و به گروه کنترل عدد سه اختصاص داده خواهد شد و تحلیلگر آماری از گروه های مطالعه مطلع نبوده و فقط بصورت کد، گروه ها را خواهد شناخت.
به شرکت کنندگان در مطالعه که واجد معیارهای ورود باشند قبل از بیهوشی و تخصیص دادن به گروه ها توسط پژوهشگر اصلی در مورد گروه کنترل و دو گروه مداخله توضیح داده خواهد شد و گفته خواهد شد که در یکی از این دوسه گروه قرار خواهند گرفت و در پایان مطالعه از گروه خود مطلع خواهندشد. ارزیابان پیامد اصلی (شیوع CRBD) و ثانوی مطالعه (شدت CRBD)، کمک پژوهشگری خواهند بود که اطلاع ندارد بیمار مورد ارزیابی در کدام گروه مطالعه قرار دارد. به گروه های مداخله به ترتیب عدد یک و دو و به گروه کنترل عدد دوسه اختصاص داده خواهد شد و تحلیلگر آماری از گروه های مطالعه مطلع نبوده و فقط بصورت کد، گروه ها را خواهد شناخت.
Primary outcomes
#1
At the moment of the patient's entry into recovery and 1, 3 and 6 hours after the patient's entry into recovery
In one, two, three and four hours after the end of anesthesia
At the moment of the patient's entry into recoveryIn one, two, three and 1, 3 and 6four hours after the patient's entry into recoveryend of anesthesia
در لحظه ورود بیمار به ریکاوری و 1، 3 و 6 ساعت پس از پایان بیهوشی
در یک، دو، سه و چهار ساعت پس از پایان بیهوشی
در لحظه ورود بیمار به ریکاورییک، دو، سه و 1، 3 و 6چهار ساعت پس از پایان بیهوشی
Secondary outcomes
#1
At the moment of the patient's entry into recovery and 1, 3 and 6 hours after the patient's entry into recovery
In one, two, three and four hours after the end of anesthesia.
At the moment of the patient's entry into recoveryIn one, two, three and 1, 3 and 6four hours after the patient's entry into recoveryend of anesthesia.
در لحظه ورود بیمار به ریکاوری و 1، 3 و 6 ساعت پس از پایان بیهوشی
در یک، دو، سه و چهار ساعت پس از پایان بیهوشی
در لحظه ورود بیمار به ریکاورییک، دو، سه و 1، 3 و 6چهار ساعت پس از پایان بیهوشی
Intervention groups
#1
Intervention group: Hyoscine N-butyl bromide made in Iran, Elixir Company, at a dose of 20 mg intravenously within one minute before extubating of a patient under non-urological surgery
Intervention group 1: Hyoscine N-butyl bromide made in Iran, Elixir Company, at a dose of 20 mg intravenously within one minute before extubating of a patient under non-urological surgery.
Intervention group 1: Hyoscine N-butyl bromide made in Iran, Elixir Company, at a dose of 20 mg intravenously within one minute before extubating of a patient under non-urological surgery.
گروه مداخله: هیوسین ان - بوتیل بروماید ساخت کشور ایران، شرکت اکسیر، با دوز 20 میلی گرم از طریق راه وریدی طی یک دقیقه قبل از اکستوبیشن بیمار تحت جراحی غیر اورولوژیک
گروه مداخله 1: هیوسین ان - بوتیل بروماید ساخت کشور ایران، شرکت اکسیر، با دوز 20 میلی گرم از طریق راه وریدی طی یک دقیقه قبل از اکستوبیشن.
گروه مداخله 1: هیوسین ان - بوتیل بروماید ساخت کشور ایران، شرکت اکسیر، با دوز 20 میلی گرم از طریق راه وریدی طی یک دقیقه قبل از اکستوبیشن بیمار تحت جراحی غیر اورولوژیک.
#2
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Prevention
prevention
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Control group: 5 g lidocaine jell made in Iran, Iran Daroo Company before placing a urinary catheter for a patient undergoing non-urological surgery
Control group: 5 g lidocaine jell made in Iran, Iran Daroo Company before placing a urinary catheter for a patient undergoing non-urological surgery
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گروه کنترل: 5 گرم ژل لیدوکائین ساخت کشور ایران، شرکت ایران دارو قبل از قرار دادن سوند ادراری برای بیمار تحت جراحی غیر اورولوژیک
گروه کنترل: 5 گرم ژل لیدوکائین ساخت کشور ایران، شرکت ایران دارو قبل از قرار دادن سوند ادراری برای بیمار تحت جراحی غیر اورولوژیک
Recruitment centers
#1
Name of recruitment center - English: Bohlool Hospital
Name of recruitment center - Persian: بیمارستان بهلول گنابادی
Full name of responsible person - English: Ali Javidi
Full name of responsible person - Persian: علی جاویدی
Street address - English: No. 36, Alley 5, Resalat St
Street address - Persian: خیابان رسالت، کوچه5، پلاک 36
City - English: Gonabad
City - Persian: گناباد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9691637744
Phone: +98 51 5725 3729
Fax:
Email: fa.freedman1992@gmail.com
Web page address: http://bohlool.gmu.ac.ir/
Name of recruitment center - English: Bohlool Hospital
Name of recruitment center - Persian: بیمارستان بهلول گنابادی
Full name of responsible person - English: Saeed Mehrabi
Full name of responsible person - Persian: سعید محرابی
Street address - English: No. 36, Alley 5, Resalat St
Street address - Persian: خیابان رسالت، کوچه5، پلاک 36
City - English: Gonabad
City - Persian: گناباد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9691637744
Phone: +98 51 5725 3729
Fax:
Email: fa.freedman1992@gmail.com
Web page address: http://bohlool.gmu.ac.ir/
Name of recruitment center - English: Bohlool Hospital Name of recruitment center - Persian: بیمارستان بهلول گنابادی Full name of responsible person - English: Ali JavidiSaeed Mehrabi Full name of responsible person - Persian: علی جاویدیسعید محرابی Street address - English: No. 36, Alley 5, Resalat St Street address - Persian: خیابان رسالت، کوچه5، پلاک 36 City - English: Gonabad City - Persian: گناباد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 9691637744 Phone: +98 51 5725 3729 Fax: Email: fa.freedman1992@gmail.com Web page address: http://bohlool.gmu.ac.ir/
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: دکتر شهلا خسروان
Full name of responsible person - Persian: Dr. Shahla Khosravan
Street address - English: No. 36, Alley 5, Resalat St.
Street address - Persian: خیابان رسالت، کوچه5، پلاک 36
City - English: Gonabad
City - Persian: گناباد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9691637744
Phone: +98 51 5725 3729
Fax:
Email: fa.freedman1992@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Shahla Khosravan
Full name of responsible person - Persian: دکتر شهلا خسروان
Street address - English: No. 36, Alley 5, Resalat St.
Street address - Persian: خیابان رسالت، کوچه5، پلاک 36
City - English: Gonabad
City - Persian: گناباد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9691637744
Phone: +98 51 5725 3729
Fax:
Email: fa.freedman1992@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: دکتر شهلا خسروانDr. Shahla Khosravan Full name of responsible person - Persian: Dr. Shahla Khosravanدکتر شهلا خسروان Street address - English: No. 36, Alley 5, Resalat St. Street address - Persian: خیابان رسالت، کوچه5، پلاک 36 City - English: Gonabad City - Persian: گناباد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 9691637744 Phone: +98 51 5725 3729 Fax: Email: fa.freedman1992@gmail.com Web page address:
Protocol summary
Study aim
Comparison of the effect of hyoscine and EMLA cream on Catheter related bladder discomfort in non-urological surgery
Design
Two arm parallel group randomized trial with blinded participants, outcome assessment and statistical analyst.
Settings and conduct
The study will assess the effectiveness of Hyoscine on CRBD compared to the EMLA group. The participants will assign equally to the groups. This study will carry out at Bohlool Hospital affiliated to Gonabad University of Medical Sciences. The participants, outcome assessment and statistical analyst will blind to the groups.
Participants/Inclusion and exclusion criteria
Having ASA class 1 or 2 , 18 to 60 years old, Elective surgery, general anesthesia and requires urinary catheterization, No history of bladder obstruction, overactive bladder, kidney and liver diseases, chronic pain, cerebrovascular disorders, cardiovascular diseases, psychosis, neurological bladder. Non-urological surgeries. No history of allergy to lidocaine or prilocaine and hyoscine, No cardiac dysrhythmia. No obvious cognitive impairment
Do not take sedatives for a long time. No kidney or liver failure. No history of drug use. No untreated glaucoma, active bleeding, Paralytic ileus, chronic lung disease and secondary tachycardia due to heart failure. Medications used before and during anesthesia should be the same.
Unwillingness to cooperate. Patients should also undergo urological surgery during the operation.
Any effective intervention or medication in addition to medications used in the routine anesthesia process
Intervention groups
group 1: Hyoscine N-butyl bromide, at a dose of 20 mg intravenously within one minute before extubating. group 2, 5 g of EMLA cream and group 3 (control): 5 g of Lidocaine jell, both of these is made in Iran, applicating before placing a urinary catheter for a patient
Main outcome variables
Incidence of CRBD
General information
Reason for update
Adding control group to study, changing the measurement time and modifying randomization mode and sample size
Acronym
CRBD
IRCT registration information
IRCT registration number:IRCT20210228050530N1
Registration date:2021-04-07, 1400/01/18
Registration timing:prospective
Last update:2021-06-03, 1400/03/13
Update count:1
Registration date
2021-04-07, 1400/01/18
Registrant information
Name
Faezeh Khajeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5725 3729
Email address
fa.freedman1992@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-08-22, 1400/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of hyoscine and EMLA cream on Catheter related bladder discomfort (CRBD) in patients undergoing non-urologic surgery
Public title
The effect of hyoscine and EMLA cream on Catheter related bladder discomfort (CRBD)
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having ASA class 1 or 2 according to the anesthesiologist record
Age between 18 and 60 years
Elective surgery with general anesthesia and requires urinary catheterization
No history of bladder obstruction, overactive bladder, severe kidney and liver diseases, chronic pain, cerebrovascular disorders, cardiovascular diseases, psychosis, neurological bladder
Non-urological surgeries.
No history of allergy to lidocaine or prilocaine and hyoscine
No cardiac dysrhythmia
No obvious cognitive impairment
Do not take sedatives for a long time
No kidney or liver failure
No history of drug use
No untreated glaucoma, active bleeding, Paralytic ileus, chronic lung disease and secondary tachycardia due to heart failure
Medications used before and during anesthesia should be the same
Exclusion criteria:
Unwillingness to cooperate
Patients should also undergo urological surgery during the operation.
Any effective intervention or medication in addition to medications used in the routine anesthesia process
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
After obtaining written consent from the participants, the patients were selected through purposive sampling method and were randomly assigned to control and intervention groups based on the permutation blocks method. To do this, the letter C, B and A will be considered for the 2% lidocaine gel (control group), EMLA and Hyoscine + lidocaine groups, respectively. Possible modes in permutation blocks method are six modes include (BCA, ACB, ABC, BAC, CBA, and CAB). Each mode will be written on a card and the cards will be assigned the number one to six. Then 35 mode is selected by using a table of random numbers, 35 numbers between 1 and 6 will be selected. The resulting blocks will be listed in order. Then, based on the list, the selected patients are divided into three groups. In order to homogenize the gender, a separate list is prepared for each of those.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Prior to anesthesia and allocation to groups, for participants who meet the inclusion criteria will be described control and two intervention groups. The participants will be explained that they will allocate into two interventions or control groups. At the end of the study, they are informed about their group.
The evaluator of primary (CRBD) and secondary outcomes (severity of CRBD) will be a person (Apart from the main researchers) who does not know the patient is in the intervention or control groups.
One, two and three will assign to two interventions and control groups, respectively. Therefore, the statistical analyst will not aware of the study groups and only will know the groups as a code.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Gonabad University of Medical Sciences
Street address
No. 36, Alley 5, Resalat St
City
Gonabad
Province
Razavi Khorasan
Postal code
9691637744
Approval date
2021-02-27, 1399/12/09
Ethics committee reference number
IR.GMU.REC.1399.125
Health conditions studied
1
Description of health condition studied
Catheter related bladder discomfort
ICD-10 code
N32.8
ICD-10 code description
Other specified disorders of bladder
Primary outcomes
1
Description
Incidence of Catheter related bladder discomfort
Timepoint
In one, two, three and four hours after the end of anesthesia
Method of measurement
Checklist for the incidence of Catheter related bladder discomfort
Secondary outcomes
1
Description
Severity of CRBD
Timepoint
In one, two, three and four hours after the end of anesthesia.
Method of measurement
Checklist of severity of CRBD of Catheter related bladder discomfort
Intervention groups
1
Description
Intervention group 1: Hyoscine N-butyl bromide made in Iran, Elixir Company, at a dose of 20 mg intravenously within one minute before extubating of a patient under non-urological surgery.
Category
Prevention
2
Description
Intervention group 2: 5 g of EMLA cream made in Iran, Iran Daroo Company before placing a urinary catheter for a patient undergoing non-urological surgery
Category
Prevention
3
Description
Control group: 5 g lidocaine jell made in Iran, Iran Daroo Company before placing a urinary catheter for a patient undergoing non-urological surgery
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Bohlool Hospital
Full name of responsible person
Saeed Mehrabi
Street address
No. 36, Alley 5, Resalat St
City
Gonabad
Province
Razavi Khorasan
Postal code
9691637744
Phone
+98 51 5725 3729
Email
fa.freedman1992@gmail.com
Web page address
http://bohlool.gmu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Shahla Khosravan
Street address
No. 36, Alley 5, Resalat St.
City
Gonabad
Province
Razavi Khorasan
Postal code
9691637744
Phone
+98 51 5725 3729
Email
fa.freedman1992@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Faezeh Khajeh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 36, Alley 5, Resalat St.
City
Gonabad
Province
Razavi Khorasan
Postal code
9691637744
Phone
+98 51 5725 3729
Email
fa.freedman1992@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Faezeh Khajeh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 36, Alley 5, Resalat St.
City
Gonabad
Province
Razavi Khorasan
Postal code
9691637744
Phone
+98 51 5725 3729
Email
fa.freedman1992@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Faezeh Khajeh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 36, Alley 5, Resalat St.
City
Gonabad
Province
Razavi Khorasan
Postal code
9691637744
Phone
+98 51 5725 3729
Email
fa.freedman1992@gmail.com
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
Thesis report
All research information will be published after being unidentified.
When the data will become available and for how long
Since 1401
To whom data/document is available
Everyone can request research results.
Under which criteria data/document could be used
Upon formal request through other members of the research team
From where data/document is obtainable
Library of Gonabad University of Medical Sciences
What processes are involved for a request to access data/document
An official request to Gonabad University of Medical Sciences