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Protocol summary
ِDeterminig the effectiveness of intravenous Dexamethasone on the incidence of nausea and vomiting after general anesthesia, in upper GI endoscopy in pediatric patients
ِDeterminig the effectiveness of intravenous Dexamethasone on the incidence of nausea and vomiting after deep sedation, in upper GI endoscopy in pediatric patients
ِDeterminig the effectiveness of intravenous Dexamethasone on the incidence of nausea and vomiting after general anesthesiadeep sedation, in upper GI endoscopy in pediatric patients
Randomized, two arm parallel group trial with blinded outcome assessment and postoperative care.
Randomized, parallel group trial with blinded outcome assessment and postoperative care.
Randomized, two arm parallel group trial with blinded outcome assessment and postoperative care.
Based on the inclusion and exclusion criteria, 98 children aged 2 to 14, candidate for an elective upper GI endoscopy are selected, and after an informed consent is taken from their parents, are randomly divided into two groups. In both groups standard monitoring devices will be installed. after preoxigenation with 100% O2, anesthesia is inducted with 2.5 mg/kg Nesdonal and deepened with Sevoflurane. Before starting endoscopy in the intervention group 0/1 mg/kg IV Dexamethasone and in the control group 2cc IV normal saline will be administered. Postoperatively, data on incidence of Nausea/vomiting and other outcomes will be collected in the recovery room, by an investigator who is blinded to the intervention allocation.
Based on the inclusion and exclusion criteria, 98 children aged 2 to 14, candidate for an elective upper GI endoscopy are selected, and after an informed consent is obtained from their parents, are randomly divided into 2 groups. In both groups standard monitoring devices will be installed. after preoxigenation with 100% O2, anesthesia is induced with 2.5 mg/kg thiopental and deepened with Sevoflurane. Preopertively, in the intervention group 0/1 mg/kg IV Dexamethasone and in the control, same volume of IV normal saline will be administered. Postoperatively, data on incidence of Nausea/vomiting and other outcomes will be collected in the recovery room, by an investigator who is blinded to the intervention allocation.
Based on the inclusion and exclusion criteria, 98 children aged 2 to 14, candidate for an elective upper GI endoscopy are selected, and after an informed consent is takenobtained from their parents, are randomly divided into two2 groups. In both groups standard monitoring devices will be installed. after preoxigenation with 100% O2, anesthesia is inductedinduced with 2.5 mg/kg Nesdonalthiopental and deepened with Sevoflurane. Before starting endoscopyPreopertively, in the intervention group 0/1 mg/kg IV Dexamethasone and in the control group 2cc, same volume of IV normal saline will be administered. Postoperatively, data on incidence of Nausea/vomiting and other outcomes will be collected in the recovery room, by an investigator who is blinded to the intervention allocation.
98 کودک 2 تا 14 ساله کاندید عمل الکتیو اندوسکوپی و فاقد معیارهای خروج مطالعه انتخاب شده و پس از اخذ رضایت نامه کتبی از والدین به شیوه تصادفی (بلوک های رندوم) به دو گروه تقسیم می شوند. در هر دو گروه پس از نصب تجهیزات مانیتورینگ استاندارد ، اخذ رگ محیطی ، القای بیهوشی در اتاق عمل پس از پره اکسیژناسیون با O2 صددرصد، با نسدونال 2.5 میلی گرم بر کیلوگرم انجام میشود . سپس با سووفلوران بیهوشی عمیق شده و پس از عمق کافی بیهوشی ، درگروه مداخله ، دگزامتازون وریدی به مقدار 0/1 میلی گرم به ازای هر کیلوگرم وزن بدن ، و در گروه شاهد، به عنوان پلاسبو ، 2 سی سی نرمال سالین وریدی تزریق شده ، سپس اندوسکوپی شروع می شود. پس از پایان عمل بیماران به ریکاوری انتقال می یابند. در ریکاوری میزان بروز تهوع و استفراغ و سایر متغیرهای مربوط به بیمار توسط فرد سومی که از گروه بیمار اطلاع ندارد، ثبت میگردد .
98 کودک 2 تا 14 ساله کاندید عمل الکتیو اندوسکوپی و فاقد معیارهای خروج مطالعه انتخاب شده و پس از اخذ رضایت نامه کتبی از والدین به شیوه تصادفی (بلوک های رندوم) به دو گروه تقسیم می شوند. در هر دو گروه پس از نصب تجهیزات مانیتورینگ استاندارد ، اخذ رگ محیطی ، القای بیهوشی در اتاق عمل پس از پره اکسیژناسیون با O2 صددرصد، با نسدونال 2.5 میلی گرم بر کیلوگرم انجام میشود . سپس با سووفلوران بیهوشی عمیق شده و پس از عمق کافی بیهوشی ، درگروه مداخله ، دگزامتازون وریدی به مقدار 0/1 میلی گرم به ازای هر کیلوگرم وزن بدن ، و در گروه شاهد، به عنوان پلاسبو ، به همان حجم نرمال سالین وریدی تزریق شده ، سپس اندوسکوپی شروع می شود. پس از پایان عمل بیماران به ریکاوری انتقال می یابند. در ریکاوری میزان بروز تهوع و استفراغ و سایر متغیرهای مربوط به بیمار توسط فرد سومی که از گروه بیمار اطلاع ندارد، ثبت میگردد .
98 کودک 2 تا 14 ساله کاندید عمل الکتیو اندوسکوپی و فاقد معیارهای خروج مطالعه انتخاب شده و پس از اخذ رضایت نامه کتبی از والدین به شیوه تصادفی (بلوک های رندوم) به دو گروه تقسیم می شوند. در هر دو گروه پس از نصب تجهیزات مانیتورینگ استاندارد ، اخذ رگ محیطی ، القای بیهوشی در اتاق عمل پس از پره اکسیژناسیون با O2 صددرصد، با نسدونال 2.5 میلی گرم بر کیلوگرم انجام میشود . سپس با سووفلوران بیهوشی عمیق شده و پس از عمق کافی بیهوشی ، درگروه مداخله ، دگزامتازون وریدی به مقدار 0/1 میلی گرم به ازای هر کیلوگرم وزن بدن ، و در گروه شاهد، به عنوان پلاسبو ، 2 سی سیبه همان حجم نرمال سالین وریدی تزریق شده ، سپس اندوسکوپی شروع می شود. پس از پایان عمل بیماران به ریکاوری انتقال می یابند. در ریکاوری میزان بروز تهوع و استفراغ و سایر متغیرهای مربوط به بیمار توسط فرد سومی که از گروه بیمار اطلاع ندارد، ثبت میگردد .
For intervention group 0/1 mg/kg IV Dexamethasone, and for control group 2cc IV normal saline will administered before operation.
For intervention group 0/1 mg/kg IV Dexamethasone, and for the control, same volume of IV normal saline will be administered before operation.
For intervention group 0/1 mg/kg IV Dexamethasone, and for the control group 2cc, same volume of IV normal saline will be administered before operation.
گروه مداخله 0/1 میلیگرم بر کیلوگرم وزن بدن دگزامتازون ،و گروه شاهد 2 سی سی نرمال سالین داخل وریدی قبل از شروع عمل دریافت می کند.
گروه مداخله 0/1 میلیگرم بر کیلوگرم وزن بدن دگزامتازون ،و گروه شاهد به همان حجم سی سی نرمال سالین داخل وریدی قبل از شروع عمل دریافت می کند.
گروه مداخله 0/1 میلیگرم بر کیلوگرم وزن بدن دگزامتازون ،و گروه شاهد 2به همان حجم سی سی نرمال سالین داخل وریدی قبل از شروع عمل دریافت می کند.
Frequency of nausea/vomiting after endoscopy
Incidence of nausea/vomiting after endoscopy
FrequencyIncidence of nausea/vomiting after endoscopy
General information
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Effectiveness of intravenous Dexamethasone on the incidence of nausea and vomiting after general anesthesia, in upper GI endoscopy in pediatric patients
Effectiveness of intravenous Dexamethasone on the incidence of nausea and vomiting after deep sedation, in upper GI endoscopy in pediatric patients
Effectiveness of intravenous Dexamethasone on the incidence of nausea and vomiting after general anesthesiadeep sedation, in upper GI endoscopy in pediatric patients
Primary outcomes
#1
Frequency of patients with nausea/vomiting
incidence of nausea/vomiting
Frequencyincidence of patients with nausea/vomiting
Recording the frequency of patients with nausea/vomiting, evaluated from their entry time to the post-anesthesia recovery room, until the time they are discharged
Recording the incidence of nausea/vomiting, evaluated during patients' stay in the post-anesthesia recovery room
Recording the frequencyincidence of patients with nausea/vomiting, evaluated from their entry time toduring patients' stay in the post-anesthesia recovery room, until the time they are discharged
Secondary outcomes
#1
Recording the highest score of patients on PAED sacle, from their time of entry to the post-anesthesia recovery room until they are discharged
Recording the highest score of patients on PAED sacle, during their stay in the post-anesthesia recovery room
Recording the highest score of patients on PAED sacle, fromduring their time of entry tostay in the post-anesthesia recovery room until they are discharged
#2
Frequency of bronchospasm/laryngospasm
incidence of bronchospasm/laryngospasm
Frequencyincidence of bronchospasm/laryngospasm
Recording the frequency of patients with bronchospasm/laryngospasm, evaluated from their entry time to the post-anesthesia recovery room, until the time they are discharged
Recording the incidence bronchospasm/laryngospasm, evaluated during patients' stay in the post-anesthesia recovery room
Recording the frequency of patients withincidence bronchospasm/laryngospasm, evaluated from their entry time toduring patients' stay in the post-anesthesia recovery room, until the time they are discharged
#3
Recording the time of patients stay in the post-anesthesia recovery room after endoscopy, until being eligible for discharge
Recording the time of patients stay in the post-anesthesia recovery room after endoscopy
Recording the time of patients stay in the post-anesthesia recovery room after endoscopy, until being eligible for discharge
Subtracting the recorded time of entry to the recovery room, from the time the patient is eligible for discharging
Subtracting the recorded time of entry to the recovery room, from the time the patient is eligible for transfer to the secondary recovery facilities
Subtracting the recorded time of entry to the recovery room, from the time the patient is eligible for dischargingtransfer to the secondary recovery facilities
#4
Patients competency assessment for discharge
Patients recovery state
Patients competency assessment for dischargerecovery state
Patients score on the Modified Aldrete scale is calculated and recorded at the time of entry to post-anesthesia recovery room, 20 minutes after entry, and at the time of discharge
Patients score on the Modified Aldrete scale is calculated and recorded at the time of entry to post-anesthesia recovery room, 5 minutes after entry, and at the time of discharge
Patients score on the Modified Aldrete scale is calculated and recorded at the time of entry to post-anesthesia recovery room, 205 minutes after entry, and at the time of discharge
امتیاز بیمار در سیستم امتیازی Modified Aldrete در هنگام ورود به ریکاوری، ۲۰ دقیقه بعد از ورود و هنگام ترخیص، ثبت می شود
امتیاز بیمار در سیستم امتیازی Modified Aldrete در هنگام ورود به ریکاوری، 5 دقیقه بعد از ورود و هنگام ترخیص، ثبت می شود
امتیاز بیمار در سیستم امتیازی Modified Aldrete در هنگام ورود به ریکاوری، ۲۰5 دقیقه بعد از ورود و هنگام ترخیص، ثبت می شود
Intervention groups
#1
Intervention group: After anesthesia is inducted and deepened, 0/1 mg/(kg of body weight) of Dexamethasone is administered to patients intravenously
Intervention group: After anesthesia is induced and deepened, 0/1 mg/(kg of body weight) of Dexamethasone is administered to patients intravenously
Intervention group: After anesthesia is inductedinduced and deepened, 0/1 mg/(kg of body weight) of Dexamethasone is administered to patients intravenously
#2
Control group: After anesthesia is inducted and deepened, 2cc of normal saline is administered to patients intravenously
Control group: After anesthesia is induced and deepened, same volume of normal saline is administered to patients intravenously
Control group: After anesthesia is inductedinduced and deepened, 2ccsame volume of normal saline is administered to patients intravenously
گروه کنترل: بعد از القا و عمیق شدن بیهوشی به صورت وریدی به میزان 2 سی سی نرمال سالین دریافت می کنند
گروه کنترل: بعد از القا و عمیق شدن بیهوشی به صورت وریدی به همان حجم نرمال سالین دریافت می کنند
گروه کنترل: بعد از القا و عمیق شدن بیهوشی به صورت وریدی به میزان 2 سی سیهمان حجم نرمال سالین دریافت می کنند
Recruitment centers
#1
Name of recruitment center - English: Tehran Childrens Medcial Center hospital
Name of recruitment center - Persian: بیمارستان مرکز طبی کودکان تهران
Full name of responsible person - English: Hamed Moheimani
Full name of responsible person - Persian: حامد مهیمنی
Street address - English: Tehran Childrens Medical Center hospital, number 62, Gharib st., Keshavarz blvd., Tehran, Iran
Street address - Persian: تهران، انتهای بلوار کشاورز، خیابان دکتر محمد قریب، جنب بیمارستان امام خمینی(ره)، پلاک ۶۲، مرکز طبی کودکان
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1479733151
Phone: +98 21 6147 2917
Fax:
Email: h-moheimani@student.tums.ac.ir
Web page address: http://chmc.tums.ac.ir/
Name of recruitment center - English: Tehran Childrens Medcial Center hospital
Name of recruitment center - Persian: بیمارستان مرکز طبی کودکان تهران
Full name of responsible person - English: Hamed Moheimani
Full name of responsible person - Persian: حامد مهیمنی
Street address - English: Tehran Childrens Medical Center hospital, number 62, Gharib st., Keshavarz blvd., Tehran, Iran
Street address - Persian: تهران، انتهای بلوار کشاورز، خیابان دکتر محمد قریب، جنب بیمارستان امام خمینی(ره)، پلاک ۶۲، مرکز طبی کودکان
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1479733151
Phone: +98 21 6147 2917
Fax:
Email: h-moheimani@alumnus.tums.ac.ir
Web page address: http://chmc.tums.ac.ir/
Name of recruitment center - English: Tehran Childrens Medcial Center hospital Name of recruitment center - Persian: بیمارستان مرکز طبی کودکان تهران Full name of responsible person - English: Hamed Moheimani Full name of responsible person - Persian: حامد مهیمنی Street address - English: Tehran Childrens Medical Center hospital, number 62, Gharib st., Keshavarz blvd., Tehran, Iran Street address - Persian: تهران، انتهای بلوار کشاورز، خیابان دکتر محمد قریب، جنب بیمارستان امام خمینی(ره)، پلاک ۶۲، مرکز طبی کودکان City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1479733151 Phone: +98 21 6147 2917 Fax: Email: h-moheimani@student.tums.ac.iralumnus.tums.ac.ir Web page address: http://chmc.tums.ac.ir/
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Hamed Moheimani
Full name of responsible person - Persian: حامد مهیمنی
Position - English: Medical student
Position - Persian: دانشجو پزشکی عمومی
Latest degree: a_level
Area of specialty/work: 40
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Central office of Tehran University of Medical sciences, on the corner of Qods st., Keshavarz Boulevard, Tehran, Iran. PC: 1417653761
Street address - Persian: تهران، بلوار کشاورز، نبش خیابان قدس، ساختمان مرکزی دانشگاه علوم پزشکی تهران، کد پستی ۱۴۱۷۶۵۳۷۶۱
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: ۱۴۱۷۶۵۳۷۶۱
Phone: +98 21 81631
Mobile: +98 911 962 4005
Fax: +98 21 8163 3047
Email: h-moheimani@student.tums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Hamed Moheimani
Full name of responsible person - Persian: حامد مهیمنی
Position - English: Medical doctor, researcher
Position - Persian: پزشک عمومی, محقق
Latest degree: med_doctor
Area of specialty/work: 40
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Central office of Tehran University of Medical sciences, on the corner of Qods st., Keshavarz Boulevard, Tehran, Iran. PC: 1417653761
Street address - Persian: تهران، بلوار کشاورز، نبش خیابان قدس، ساختمان مرکزی دانشگاه علوم پزشکی تهران، کد پستی ۱۴۱۷۶۵۳۷۶۱
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1417653761
Phone: +98 21 81631
Mobile: +98 911 962 4005
Fax: +98 21 8163 3047
Email: h-moheimani@alumnus.tums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Hamed Moheimani Full name of responsible person - Persian: حامد مهیمنی Position - English: Medical studentdoctor, researcher Position - Persian: دانشجو پزشکیپزشک عمومی, محقق Latest degree: amed_leveldoctor Area of specialty/work: 40 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Central office of Tehran University of Medical sciences, on the corner of Qods st., Keshavarz Boulevard, Tehran, Iran. PC: 1417653761 Street address - Persian: تهران، بلوار کشاورز، نبش خیابان قدس، ساختمان مرکزی دانشگاه علوم پزشکی تهران، کد پستی ۱۴۱۷۶۵۳۷۶۱ City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: ۱۴۱۷۶۵۳۷۶۱1417653761 Phone: +98 21 81631 Mobile: +98 911 962 4005 Fax: +98 21 8163 3047 Email: h-moheimani@student.tums.ac.iralumnus.tums.ac.ir Web page address:
Person responsible for scientific inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Hamed Moheimani
Full name of responsible person - Persian: حامد مهیمنی
Position - English: Medical student
Position - Persian: دانشجو پزشکی عمومی
Latest degree: a_level
Area of specialty/work: 40
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Central office of Tehran University of Medical sciences, on the corner of Qods st., Keshavarz Boulevard, Tehran, Iran. PC: 1417653761
Street address - Persian: تهران، بلوار کشاورز، نبش خیابان قدس، ساختمان مرکزی دانشگاه علوم پزشکی تهران، کد پستی ۱۴۱۷۶۵۳۷۶۱
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: ۱۴۱۷۶۵۳۷۶۱
Phone: +98 21 81631
Mobile: +98 911 962 4005
Fax: +98 21 8163 3047
Email: h-moheimani@student.tums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Hamed Moheimani
Full name of responsible person - Persian: حامد مهیمنی
Position - English: Medical doctor, researcher
Position - Persian: پزشک عمومی, محقق
Latest degree: med_doctor
Area of specialty/work: 40
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Central office of Tehran University of Medical sciences, on the corner of Qods st., Keshavarz Boulevard, Tehran, Iran. PC: 1417653761
Street address - Persian: تهران، بلوار کشاورز، نبش خیابان قدس، ساختمان مرکزی دانشگاه علوم پزشکی تهران، کد پستی ۱۴۱۷۶۵۳۷۶۱
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1417653761
Phone: +98 21 81631
Mobile: +98 911 962 4005
Fax: +98 21 8163 3047
Email: h-moheimani@alumnus.tums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Hamed Moheimani Full name of responsible person - Persian: حامد مهیمنی Position - English: Medical studentdoctor, researcher Position - Persian: دانشجو پزشکیپزشک عمومی, محقق Latest degree: amed_leveldoctor Area of specialty/work: 40 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Central office of Tehran University of Medical sciences, on the corner of Qods st., Keshavarz Boulevard, Tehran, Iran. PC: 1417653761 Street address - Persian: تهران، بلوار کشاورز، نبش خیابان قدس، ساختمان مرکزی دانشگاه علوم پزشکی تهران، کد پستی ۱۴۱۷۶۵۳۷۶۱ City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: ۱۴۱۷۶۵۳۷۶۱1417653761 Phone: +98 21 81631 Mobile: +98 911 962 4005 Fax: +98 21 8163 3047 Email: h-moheimani@student.tums.ac.iralumnus.tums.ac.ir Web page address:
Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Hamed Moheimani
Full name of responsible person - Persian: حامد مهیمنی
Position - English: Medical student
Position - Persian: دانشجو پزشکی عمومی
Latest degree: a_level
Area of specialty/work: 40
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Central office of Tehran University of Medical sciences, on the corner of Qods st., Keshavarz Boulevard, Tehran, Iran. PC: 1417653761
Street address - Persian: تهران، بلوار کشاورز، نبش خیابان قدس، ساختمان مرکزی دانشگاه علوم پزشکی تهران، کد پستی ۱۴۱۷۶۵۳۷۶۱
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: ۱۴۱۷۶۵۳۷۶۱
Phone: +98 21 81631
Mobile: +98 911 962 4005
Fax: +98 21 8163 3047
Email: h-moheimani@student.tums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Hamed Moheimani
Full name of responsible person - Persian: حامد مهیمنی
Position - English: Medical doctor, researcher
Position - Persian: پزشک عمومی, محقق
Latest degree: med_doctor
Area of specialty/work: 40
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Central office of Tehran University of Medical sciences, on the corner of Qods st., Keshavarz Boulevard, Tehran, Iran. PC: 1417653761
Street address - Persian: تهران، بلوار کشاورز، نبش خیابان قدس، ساختمان مرکزی دانشگاه علوم پزشکی تهران، کد پستی ۱۴۱۷۶۵۳۷۶۱
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1417653761
Phone: +98 21 81631
Mobile: +98 911 962 4005
Fax: +98 21 8163 3047
Email: h-moheimani@alumnus.tums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Hamed Moheimani Full name of responsible person - Persian: حامد مهیمنی Position - English: Medical studentdoctor, researcher Position - Persian: دانشجو پزشکیپزشک عمومی, محقق Latest degree: amed_leveldoctor Area of specialty/work: 40 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Central office of Tehran University of Medical sciences, on the corner of Qods st., Keshavarz Boulevard, Tehran, Iran. PC: 1417653761 Street address - Persian: تهران، بلوار کشاورز، نبش خیابان قدس، ساختمان مرکزی دانشگاه علوم پزشکی تهران، کد پستی ۱۴۱۷۶۵۳۷۶۱ City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: ۱۴۱۷۶۵۳۷۶۱1417653761 Phone: +98 21 81631 Mobile: +98 911 962 4005 Fax: +98 21 8163 3047 Email: h-moheimani@student.tums.ac.iralumnus.tums.ac.ir Web page address:
Protocol summary
Study aim
ِDeterminig the effectiveness of intravenous Dexamethasone on the incidence of nausea and vomiting after deep sedation, in upper GI endoscopy in pediatric patients
Design
Randomized, parallel group trial with blinded outcome assessment and postoperative care.
Settings and conduct
Based on the inclusion and exclusion criteria, 98 children aged 2 to 14, candidate for an elective upper GI endoscopy are selected, and after an informed consent is obtained from their parents, are randomly divided into 2 groups. In both groups standard monitoring devices will be installed. after preoxigenation with 100% O2, anesthesia is induced with 2.5 mg/kg thiopental and deepened with Sevoflurane. Preopertively, in the intervention group 0/1 mg/kg IV Dexamethasone and in the control, same volume of IV normal saline will be administered. Postoperatively, data on incidence of Nausea/vomiting and other outcomes will be collected in the recovery room, by an investigator who is blinded to the intervention allocation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All 2 to 14 year-old children, who are a candidate for an elective upper GI endoscopy, and whose parents have given an informed consent; Exclusion criteria: Patients with a history of hypersensitivity to the drugs studied, metabolic disease or diabetes, anatomical upper airway disorders, Patients diagnosed with behavioral disorders or currently taking psychiatric medication, patients who have previously undergone chemotherapy or have taken a sedative/hypnotic drug prior to endoscopy, Patients who are a candidate for an emergency endoscopy or whose operation is complicated and takes too long to be completed
Intervention groups
For intervention group 0/1 mg/kg IV Dexamethasone, and for the control, same volume of IV normal saline will be administered before operation.
Main outcome variables
Incidence of nausea/vomiting after endoscopy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180929041173N1
Registration date:2018-10-26, 1397/08/04
Registration timing:prospective
Last update:2018-12-09, 1397/09/18
Update count:2
Registration date
2018-10-26, 1397/08/04
Registrant information
Name
Hamed Moheimani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 81631
Email address
h-moheimani@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-03, 1397/08/12
Expected recruitment end date
2018-11-13, 1397/08/22
Actual recruitment start date
2018-11-03, 1397/08/12
Actual recruitment end date
2018-11-21, 1397/08/30
Trial completion date
2018-11-21, 1397/08/30
Scientific title
Effectiveness of intravenous Dexamethasone on the incidence of nausea and vomiting after deep sedation, in upper GI endoscopy in pediatric patients
Public title
Antiemetic effect of Dexamethasone in pediatric endosocopy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All 2 to 14 year-old children, candidate for an elective upper GI endoscopy, according to the pediatric gastroenterologist diagnosis
Exclusion criteria:
Patients with a history of hypersensitivity to the drugs studied
Patients with a history of metabolic disease or diabetes
Patients with anatomical upper airway disorders
Patients diagnosed with behavioral disorders or currently taking psychiatric medication
Patients with a history of undergoing chemotherapy
Patients who have taken a sedative/hypnotic drug prior to endoscopy
Patients who are a candidate for an emergency endoscopy
Patients whose operation is complicated (e.g. by bleeding) and takes too long to be completed
Patients without a parental informed consent
Age
From 2 years old to 14 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
98
Actual sample size reached:
98
Randomization (investigator's opinion)
Randomized
Randomization description
A statistical computer program is used to make random block stratified individual assignments with user selected block sizes. The psuedonumber generator is a linear congruential algorithm of Park and Milller with Bays-Durham shuffling. The random sheets will be given directly to nurse administrating the drugs and neither the participants nor the researcher collecting the data will be informed of the method of drug allocation to patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
The randomly allocated list of patients will be given exclusively to the nurse administrating the drugs. Participants, gastroenterologist performing endoscopy, attending anesthesiologist, recovery nurse and the researcher collecting data will not be informed of the method of drug allocation to patients.
(The parents of participants will be thoroughly informed that this clinical trial uses a randomized method before giving consent)
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Central office of Tehran University of Medical sciences, on the corner of Qods st., Keshavarz Boulevard, Tehran, Iran. PC: 1417653761
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-10-17, 1397/07/25
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1397.505
Health conditions studied
1
Description of health condition studied
Post endoscopy nausea and vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
incidence of nausea/vomiting
Timepoint
Recording the incidence of nausea/vomiting, evaluated during patients' stay in the post-anesthesia recovery room
Method of measurement
Investigator evaluation and examination
Secondary outcomes
1
Description
Post anesthesia emergence delirium
Timepoint
Recording the highest score of patients on PAED sacle, during their stay in the post-anesthesia recovery room
Recording the incidence bronchospasm/laryngospasm, evaluated during patients' stay in the post-anesthesia recovery room
Method of measurement
Investigator evaluation and examination
3
Description
Time needed for patient recovery after endoscopy
Timepoint
Recording the time of patients stay in the post-anesthesia recovery room after endoscopy
Method of measurement
Subtracting the recorded time of entry to the recovery room, from the time the patient is eligible for transfer to the secondary recovery facilities
4
Description
Patients recovery state
Timepoint
Patients score on the Modified Aldrete scale is calculated and recorded at the time of entry to post-anesthesia recovery room, 5 minutes after entry, and at the time of discharge
Method of measurement
Modified Aldrete scale
Intervention groups
1
Description
Intervention group: After anesthesia is induced and deepened, 0/1 mg/(kg of body weight) of Dexamethasone is administered to patients intravenously
Category
Treatment - Drugs
2
Description
Control group: After anesthesia is induced and deepened, same volume of normal saline is administered to patients intravenously
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Childrens Medcial Center hospital
Full name of responsible person
Hamed Moheimani
Street address
Tehran Childrens Medical Center hospital, number 62, Gharib st., Keshavarz blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1479733151
Phone
+98 21 6147 2917
Email
h-moheimani@alumnus.tums.ac.ir
Web page address
http://chmc.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Central office of Tehran University of Medical sciences, on the corner of Qods st., Keshavarz Boulevard, Tehran, Iran. PC: 1417653761
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3686
Fax
+98 21 8163 3623
Email
rmo@tums.ac.ir
Web page address
http://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamed Moheimani
Position
Medical doctor, researcher
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Central office of Tehran University of Medical sciences, on the corner of Qods st., Keshavarz Boulevard, Tehran, Iran. PC: 1417653761
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 81631
Fax
+98 21 8163 3047
Email
h-moheimani@alumnus.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamed Moheimani
Position
Medical doctor, researcher
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Central office of Tehran University of Medical sciences, on the corner of Qods st., Keshavarz Boulevard, Tehran, Iran. PC: 1417653761
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 81631
Fax
+98 21 8163 3047
Email
h-moheimani@alumnus.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamed Moheimani
Position
Medical doctor, researcher
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Central office of Tehran University of Medical sciences, on the corner of Qods st., Keshavarz Boulevard, Tehran, Iran. PC: 1417653761
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 81631
Fax
+98 21 8163 3047
Email
h-moheimani@alumnus.tums.ac.ir
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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available