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Protocol summary
Clinical trial with control group, with parallel groups, single blind, randomized, phase three on 90 patients (30 people in each of the three groups). For randomization from the website www. sealedenvelope.com/simple-randomiser/v1/lists was used.
Clinical trial with control group, with parallel groups, single blind, randomized, phase three on 60 patients (20 people in each of the three groups). For randomization from the website www. sealedenvelope.com/simple-randomiser/v1/lists was used.
Clinical trial with control group, with parallel groups, single blind, randomized, phase three on 9060 patients (3020 people in each of the three groups). For randomization from the website www. sealedenvelope.com/simple-randomiser/v1/lists was used.
کار آزمایی بالینی دارای گروه كنترل, با گروه هاي موازي، یک سویه کور, تصادفی شده, فاز سه بر روي 90 بيمار (30 نفر در هر كدام از سه گروه). براي تصادفي سازي از وب سايت www. sealedenvelope.com/simple-randomiser/v1/lists استفاده شد.
کار آزمایی بالینی دارای گروه كنترل, با گروه هاي موازي، یک سویه کور, تصادفی شده, فاز سه بر روي 60 بيمار (20 نفر در هر كدام از سه گروه). براي تصادفي سازي از وب سايت www. sealedenvelope.com/simple-randomiser/v1/lists استفاده شد.
کار آزمایی بالینی دارای گروه كنترل, با گروه هاي موازي، یک سویه کور, تصادفی شده, فاز سه بر روي 9060 بيمار (3020 نفر در هر كدام از سه گروه). براي تصادفي سازي از وب سايت www. sealedenvelope.com/simple-randomiser/v1/lists استفاده شد.
General information
90
60
9060
empty
Over the past year, the presence of coronavirus pandemics and specific conditions in the country and consecutive closures have led to a significant reduction in referrals (elective patients) to the hospital and endoscopy unit.
Due to this, the process of collecting samples has become very slow
Considering that the estimated number of samples is 90 people and so far we have managed to collect 60 samples after 9 months, we need to adjust the number of samples. Note that my residency ended 7 months ago.
Over the past year, the presence of coronavirus pandemics and specific conditions in the country and consecutive closures have led to a significant reduction in referrals (elective patients) to the hospital and endoscopy unit. Due to this, the process of collecting samples has become very slow Considering that the estimated number of samples is 90 people and so far we have managed to collect 60 samples after 9 months, we need to adjust the number of samples. Note that my residency ended 7 months ago.
empty
نظر به اینکه طی یک سال گذشته وجود پاندمی کرونا ویروس و شرایط خاص کشور و تعطیلی های پی در پی منجر به کاهش قابل توجه مراجعین (بیماران الکتیو) به بیمارستان و واحد آندوسکوپی گردیده است لذا روند جمع آوری نمونه های طرح تحقیقاتی اینجانب با موضوع "مقایسه اثر دگزامتازون و اندانسترون در پیشگیری از تهوع استفراغ و دلیریوم در کودکان تحت اندوسکوپی فوقانی" با شناسه کار آزمایی 50291 بسیار کند شده است.
با توجه به اینکه تعداد نمونه های برآوردشده 90 نفر در نظر گرفته شده و تا کنون بعد از گذشت 9 ماه موفق به جمع آوری 60 نمونه شده ایم نیازمند تعدیل تعداد نمو نه ها هستیم با توجه به اینکه اینجانب در شهریور 99 دوره رزیدنسی را به اتمام رسانده ام لطفا راهنمایی بفرمایید.
با تشکر
نظر به اینکه طی یک سال گذشته وجود پاندمی کرونا ویروس و شرایط خاص کشور و تعطیلی های پی در پی منجر به کاهش قابل توجه مراجعین (بیماران الکتیو) به بیمارستان و واحد آندوسکوپی گردیده است لذا روند جمع آوری نمونه های طرح تحقیقاتی اینجانب با موضوع "مقایسه اثر دگزامتازون و اندانسترون در پیشگیری از تهوع استفراغ و دلیریوم در کودکان تحت اندوسکوپی فوقانی" با شناسه کار آزمایی 50291 بسیار کند شده است. با توجه به اینکه تعداد نمونه های برآوردشده 90 نفر در نظر گرفته شده و تا کنون بعد از گذشت 9 ماه موفق به جمع آوری 60 نمونه شده ایم نیازمند تعدیل تعداد نمو نه ها هستیم با توجه به اینکه اینجانب در شهریور 99 دوره رزیدنسی را به اتمام رسانده ام لطفا راهنمایی بفرمایید. با تشکر
First, the group receiving dexamethasone was coded with the letter A, the group receiving ondansetron with the letter B and the control group with the letter C, and then using the website
www. sealedenvelope.com/simple-randomiser/v1/lists
Randomization list was prepared by selecting a sample size of 90 (three groups of 30) and Permuted block randomization method (block size=6) (15 blocks of 6). Then, through the obtained randomization list, the subjects will be assigned to one of the three groups A or B or C. For example, suppose that in the first six blocks, the permutation method is AABCBC, so the first and second samples are group A (dexamethasone), the third and fifth samples are group B (ondansetron), and the fourth and sixth samples are Group C (control) will be assigned and the same will continue until the last sample (90th person).
First, the group receiving dexamethasone was coded with the letter A, the group receiving ondansetron with the letter B and the control group with the letter C, and then using the website
www. sealedenvelope.com/simple-randomiser/v1/lists
Randomization list was prepared by selecting a sample size of 60 (three groups of 30) and Permuted block randomization method (block size=6) (10 blocks of 6). Then, through the obtained randomization list, the subjects will be assigned to one of the three groups A or B or C. For example, suppose that in the first six blocks, the permutation method is AABCBC, so the first and second samples are group A (dexamethasone), the third and fifth samples are group B (ondansetron), and the fourth and sixth samples are Group C (control) will be assigned and the same will continue until the last sample (60th person).
First, the group receiving dexamethasone was coded with the letter A, the group receiving ondansetron with the letter B and the control group with the letter C, and then using the website www. sealedenvelope.com/simple-randomiser/v1/lists Randomization list was prepared by selecting a sample size of 9060 (three groups of 30) and Permuted block randomization method (block size=6) (1510 blocks of 6). Then, through the obtained randomization list, the subjects will be assigned to one of the three groups A or B or C. For example, suppose that in the first six blocks, the permutation method is AABCBC, so the first and second samples are group A (dexamethasone), the third and fifth samples are group B (ondansetron), and the fourth and sixth samples are Group C (control) will be assigned and the same will continue until the last sample (90th60th person).
ابتدا گروه دريافت كننده دگزامتازون را با حرف A، گروه دريافت كننده اندانسترون را با حرف B و گروه کنترل را با حرف C کدگذاری کرده و سپس با استفاده از وب سایت
www. sealedenvelope.com/simple-randomiser/v1/lists
لیست تصادفی سازی را با انتخاب حجم نمونه 90 (سه گروه 30 تایی) و با روش بلوک بندی شش تایی متعادل شده (15 بلوک 6 تایی) تهیه شد. سپس از طریق لیست تصادفی سازی بدست آمده، افراد وارد شده به مطالعه به یکی از سه گروه A یا B یا C تخصیص داده خواهند شد. به عنوان مثال فرض شود که در بلوک شش تایی اول، نحوه جایگشت به صورت AABCBC باشد بنابراین اولین و دومین نمونه به گروه A (دريافت كننده دگزامتازون)، سومین و پنجمین نمونه به گروه B (دريافت كننده اندانسترون) و چهارمین و ششمین نمونه به گروه C (کنترل) تخصیص داده خواهند شد و به همین منوال تا آخرین نمونه (نفر 90 ام) ادامه خواهد یافت.
ابتدا گروه دريافت كننده دگزامتازون را با حرف A، گروه دريافت كننده اندانسترون را با حرف B و گروه کنترل را با حرف C کدگذاری کرده و سپس با استفاده از وب سایت
www. sealedenvelope.com/simple-randomiser/v1/lists
لیست تصادفی سازی را با انتخاب حجم نمونه 60 (سه گروه 20 تایی) و با روش بلوک بندی شش تایی متعادل شده (10 بلوک 6 تایی) تهیه شد. سپس از طریق لیست تصادفی سازی بدست آمده، افراد وارد شده به مطالعه به یکی از سه گروه A یا B یا C تخصیص داده خواهند شد. به عنوان مثال فرض شود که در بلوک شش تایی اول، نحوه جایگشت به صورت AABCBC باشد بنابراین اولین و دومین نمونه به گروه A (دريافت كننده دگزامتازون)، سومین و پنجمین نمونه به گروه B (دريافت كننده اندانسترون) و چهارمین و ششمین نمونه به گروه C (کنترل) تخصیص داده خواهند شد و به همین منوال تا آخرین نمونه (نفر 60 ام) ادامه خواهد یافت.
ابتدا گروه دريافت كننده دگزامتازون را با حرف A، گروه دريافت كننده اندانسترون را با حرف B و گروه کنترل را با حرف C کدگذاری کرده و سپس با استفاده از وب سایت www. sealedenvelope.com/simple-randomiser/v1/lists لیست تصادفی سازی را با انتخاب حجم نمونه 9060 (سه گروه 3020 تایی) و با روش بلوک بندی شش تایی متعادل شده (1510 بلوک 6 تایی) تهیه شد. سپس از طریق لیست تصادفی سازی بدست آمده، افراد وارد شده به مطالعه به یکی از سه گروه A یا B یا C تخصیص داده خواهند شد. به عنوان مثال فرض شود که در بلوک شش تایی اول، نحوه جایگشت به صورت AABCBC باشد بنابراین اولین و دومین نمونه به گروه A (دريافت كننده دگزامتازون)، سومین و پنجمین نمونه به گروه B (دريافت كننده اندانسترون) و چهارمین و ششمین نمونه به گروه C (کنترل) تخصیص داده خواهند شد و به همین منوال تا آخرین نمونه (نفر 9060 ام) ادامه خواهد یافت.
Recruitment centers
#1
Name of recruitment center - English: Kashan Shahid Beheshti Hospital
Name of recruitment center - Persian: بیمارستان شهید بهشتی کاشان
Full name of responsible person - English: Dr.Ramin Madani - Dr. Mahsa Nassaj
Full name of responsible person - Persian: دکتر رامین مدنی - دکتر مهسا نساج
Street address - English: Qutb Ravandi Boulevard
Street address - Persian: بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 87159/81151
Phone: +98 31 5554 0026
Fax: +98 31 5554 8900
Email: beheshtihospital@kaums.ac.ir
Web page address:
Name of recruitment center - English: Kashan Shahid Beheshti Hospital
Name of recruitment center - Persian: بیمارستان شهید بهشتی کاشان
Full name of responsible person - English: Dr.Ramin Madani ,Dr. Mahsa Nassaj
Full name of responsible person - Persian: دکتر رامین مدنی - دکتر مهسا نساج
Street address - English: Qutb Ravandi Boulevard
Street address - Persian: بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 87159/81151
Phone: +98 31 5554 0026
Fax: +98 31 5554 8900
Email: beheshtihospital@kaums.ac.ir
Web page address:
Name of recruitment center - English: Kashan Shahid Beheshti Hospital Name of recruitment center - Persian: بیمارستان شهید بهشتی کاشان Full name of responsible person - English: Dr.Ramin Madani - ,Dr. Mahsa Nassaj Full name of responsible person - Persian: دکتر رامین مدنی - دکتر مهسا نساج Street address - English: Qutb Ravandi Boulevard Street address - Persian: بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 87159/81151 Phone: +98 31 5554 0026 Fax: +98 31 5554 8900 Email: beheshtihospital@kaums.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: آقاي دكتر حميدرضا بنفشه
Full name of responsible person - Persian: Dr. Hamidreza Banafsheh
Street address - English: Qutb Ravandi Boulevard
Street address - Persian: بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8115187159
Phone: +98 31 5557 8010
Fax:
Email: education@kaums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Hamidreza Banafsheh
Full name of responsible person - Persian: آقاي دكتر حميدرضا بنفشه
Street address - English: Qutb Ravandi Boulevard
Street address - Persian: بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8115187159
Phone: +98 31 5557 8010
Fax:
Email: education@kaums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: آقاي دكتر حميدرضا بنفشهDr. Hamidreza Banafsheh Full name of responsible person - Persian: Dr. Hamidreza Banafshehآقاي دكتر حميدرضا بنفشه Street address - English: Qutb Ravandi Boulevard Street address - Persian: بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8115187159 Phone: +98 31 5557 8010 Fax: Email: education@kaums.ac.ir Web page address:
Protocol summary
Study aim
Comparison of the effect of administering injectable dexamethasone with injectable ondansetron before upper endoscopy in reducing of PONV and Delirium in Children referred to Kashan Shahid Beheshti Hospital and Isfahan Imam Hossein Children's Hospital 2020
Design
Clinical trial with control group, with parallel groups, single blind, randomized, phase three on 60 patients (20 people in each of the three groups). For randomization from the website www. sealedenvelope.com/simple-randomiser/v1/lists was used.
Settings and conduct
This study is a single- blind clinical trial (participants did not know how to do the work) on upper endoscopic candidate children referred to Beheshti Hospital in Kashan and Imam Hossein in Isfahan, After receiving informed written consent from their parents. Patients are randomly allocated into dexamethasone, ondansetron and control groups. All patients undergo a pre-determined and uniform procedure and will undergo standard venipuncture and monitoring. To maintain anesthesia, an endoscopic mask with an endoscope passage and no leakage will be used at the same time as the endoscopy. Anesthesia is performed with midazolam and then propofol under the supervision of an anesthesiologist. Prior to UGIE, one group received 0.1 mg / kg intravenous dexamethasone, the other group received 0.15 mg / kg intravenous ondansetron, and the control group did not receive any medication.
Participants/Inclusion and exclusion criteria
Children 5 to 14 years of age, diagnosed by a gastroenterologist, are candidates for elective UGIE under deep anesthesia.
Intervention groups
In the two intervention groups, when the patient was sufficiently anesthetized, one group received dexamethasone 0.1 mg / kg and the other group, ondansetron 0.15 mg / kg, was not given the control group.
Main outcome variables
PONV, Delirium
General information
Reason for update
Over the past year, the presence of coronavirus pandemics and specific conditions in the country and consecutive closures have led to a significant reduction in referrals (elective patients) to the hospital and endoscopy unit.
Due to this, the process of collecting samples has become very slow
Considering that the estimated number of samples is 90 people and so far we have managed to collect 60 samples after 9 months, we need to adjust the number of samples. Note that my residency ended 7 months ago.
Acronym
IRCT registration information
IRCT registration number:IRCT20200809048343N1
Registration date:2020-11-13, 1399/08/23
Registration timing:registered_while_recruiting
Last update:2021-04-28, 1400/02/08
Update count:1
Registration date
2020-11-13, 1399/08/23
Registrant information
Name
Mahsa Nassaj
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5534 0342
Email address
mahsa.nassaj87@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-02-18, 1399/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Dexamethasone and Ondansetron on nausea,vomiting and delirium in children undergoing upper GI endoscopy
Public title
Comparison of the effect of Dexamethasone and Ondansetron on nausea , vomiting and delirium in children undergoing upper GI endoscopy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Children 5 to 14 years old who are candidates for UGIE with deep anesthesia
ASA stage : 1 , 2
Modified APFEL score 0 , 1
Exclusion criteria:
History of allergies to the drugs used in the study
History of previous chemotherapy
History of malignancy
History of metabolic disease
History of diabet
Upper respiratory tract anatomical disease
Treatment with Psychiatric drugs/Behavioural disorder
Children who have received sedatives before the procedure.
Children who are candidates for ERCP or emergency endoscopy
Children who receive higher doses of the drug due to the difficulty of the operation to prolong the duration of anesthesia
Age
From 5 years old to 14 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
First, the group receiving dexamethasone was coded with the letter A, the group receiving ondansetron with the letter B and the control group with the letter C, and then using the website
www. sealedenvelope.com/simple-randomiser/v1/lists
Randomization list was prepared by selecting a sample size of 60 (three groups of 30) and Permuted block randomization method (block size=6) (10 blocks of 6). Then, through the obtained randomization list, the subjects will be assigned to one of the three groups A or B or C. For example, suppose that in the first six blocks, the permutation method is AABCBC, so the first and second samples are group A (dexamethasone), the third and fifth samples are group B (ondansetron), and the fourth and sixth samples are Group C (control) will be assigned and the same will continue until the last sample (60th person).
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, participants did not know how to work and prescribe drugs.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Science
Street address
3 km of Ravand road, Physician Boulevard., Medical School
City
Kashan
Province
Isfehan
Postal code
8715988141
Approval date
2020-07-13, 1399/04/23
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1399.053
Health conditions studied
1
Description of health condition studied
dyspepsia
ICD-10 code
R10.1
ICD-10 code description
Dyspepsia NOS /Epigastric pain
Primary outcomes
1
Description
Percentage of people with nausea and vomiting
Timepoint
Existence of nausea-vomiting after the intervention
Method of measurement
view
2
Description
Intensity of delirium in individuals
Timepoint
Measurement of delirium severity after intervention (during recovery)
Method of measurement
PAED Scaling Score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the dexamethasone group, 0.1 mg / kg dexamethasone is injected when the anesthesia level is sufficient.
Category
Prevention
2
Description
Intervention group: In the ondansetron group, 0.15 mg / kg of ondansetron is injected when the anesthesia level is sufficient.
Category
Prevention
3
Description
Control group: In the control group, no drug is injected.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Esfahan Imam Hossein Hospital
Full name of responsible person
Dr.Sedigheh Shahhosseini
Street address
Imam Khomeini St., before Esteghlal Square, Imam Hossein Educational and Medical Center
City
Esfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Fax
+98 31 3386 8286
Email
emamhossein_hospital@mui.ac.ir
2
Recruitment center
Name of recruitment center
Kashan Shahid Beheshti Hospital
Full name of responsible person
Dr.Ramin Madani ,Dr. Mahsa Nassaj
Street address
Qutb Ravandi Boulevard
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 0026
Fax
+98 31 5554 8900
Email
beheshtihospital@kaums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Hamidreza Banafsheh
Street address
Qutb Ravandi Boulevard
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5557 8010
Email
education@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
50
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
Kashan University of Medical Sciences
Full name of responsible person
Dr.Mahsa Nassaj
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Amir Kabir Street
City
Kashan
Province
Isfehan
Postal code
8718646351
Phone
+98 31 5534 0342
Email
mahsa.nassaj87@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr.Ramin Madani
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Qutb Ravandi Boulevard
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5531 7889
Email
drraminmadani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr.Mahsa Nassaj
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Amirkabir Street
City
Kashan
Province
Isfehan
Postal code
8718646351
Phone
+98 31 5534 0342
Email
mahsa.nassaj87@gmail.com
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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Its release schedule is not yet known
When the data will become available and for how long
Its release schedule is not yet known
To whom data/document is available
Its release schedule is not yet known
Under which criteria data/document could be used
Its release schedule is not yet known
From where data/document is obtainable
Its release schedule is not yet known
What processes are involved for a request to access data/document