Comparison of the effect of using ketamine and midazolam compared to propofol and midazolam on vital signs during gastroduodenoscopy in children referred to Bandar Abbas medical centers
The findings of this study, considering the sensitivity of gastroduodenoscopy in children, can be helpful in finding a suitable combination of anesthetics and anesthetics.
Design
A randomized clinical trial, double-blind, phase 4 on 44 patients, using a table of random numbers for randomization.
Settings and conduct
According to the double-blind randomization method (in each of the groups, the desired drug is injected into the patient by an anesthesiologist, but the information required for the research is recorded by an independent researcher who does not know the type of drug and the study group.
This study is conducted in Bandar Abbas Children's Hospital and Bandar Abbas Children's Clinic
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having informed consent Children aged 2 to 16 years with ASA class 1 or 2
Exit criteria: Allergy to any of the drugs used in the study Emergency endoscopy Contraindications for prescribing ketamine
Intervention groups
In one group of patients, 0.03 mg/kg intravenous midazolam and 1 mg/kg propofol 1% will be given intravenously and they will undergo endoscopy. In the other group of patients, first, 0.03 mg/kg of intravenous midazolam and 1 mg/kg of intravenous ketamine are given and they undergo endoscopy. During the surgery, patients are under continuous heart monitoring and oxygen saturation percentage
Comparison of the effect of using ketamine and midazolam compared to propofol and midazolam on vital signs during gastroduodenoscopy in children referred to Bandar Abbas medical centers
Public title
Comparison of the effect of using ketamine and midazolam compared to propofol and midazolam on vital signs during gastroduodenoscopy in children referred to Bandar Abbas medical centers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having informed consent
Children aged 2 to 16 years
ASA class 1 or 2
candidates for upper gastrointestinal endoscopy
Exclusion criteria:
Allergy to any of the drugs used in the study
Emergency endoscopy
Contraindications for prescribing ketamine (history of neurological and psychiatric diseases, history of brain space-occupying lesions, heart rhythm disorders)
Age
From 2 years old to 16 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Generation of random numbers from the table of random numbers: Considering that 44 patients are needed in this study, a number is randomly selected in the table of random numbers and the two digits on the right side of it are taken into account. If these two digits were an even number, The patient is assigned to the intervention group (A) and if he is an individual, to the control group (B). For example, the number 73 was chosen in the table of random numbers, since the number 73 is an odd number, so the first sample will be assigned to the control group. In the table, random numbers move in rows from left to right, and with the above pattern, the method of assigning people to two groups is determined.
Blinding (investigator's opinion)
Double blinded
Blinding description
In each of the groups, the desired drug is injected into the patient by an anesthesiologist, but the information required for the research is recorded by an independent researcher who does not know the type of drug and the study group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hormozgan University of Medical Sciences
Street address
Shahid Mohammadi Hospital
City
Bandarabbas
Province
Hormozgan
Postal code
7916613885
Approval date
2022-12-28, 1401/10/07
Ethics committee reference number
IR.HUMS.REC.1401.328
Health conditions studied
1
Description of health condition studied
Gastrointestinal problems
ICD-10 code
K20-K31
ICD-10 code description
Diseases of oesophagus, stomach and duodenum
Primary outcomes
1
Description
The rate of sedation during pediatric gastroduodenoscopy
Timepoint
Before, during, and at the discharge from recovery
Method of measurement
Aldrete score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 0.03 mg/kg of intravenous midazolam and 1 mg/kg of propofol 1% will be given intravenously and they will undergo endoscopy.
Category
Treatment - Drugs
2
Description
Intervention group: receives intravenous midazolam 0.03 mg/kg and intravenous ketamine 1 mg/kg and undergo endoscopy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mohammadi Hospital
Full name of responsible person
Samira Zanbag
Street address
Bandar Abbas- Shahid Mohammadi Hospital
City
Bandar abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3334 5000
Email
info@hums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Samira Zanbag
Street address
Bandar Abbas-Shahid Mohammadi Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3334 5000
Email
info@hums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
شخصی
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Behnaz Darban
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Bandar Abbas-Shahid Mohammadi Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 912 084 5006
Email
Darban.sam@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Samira Zanbag
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Bandar Abbas-Shahid Mohammadi Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 913 357 6114
Email
samira.zanbagh66@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
nasim abdi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Bandar Abbas-Shahid Mohammadi Hospital
City
bandar abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 917 364 0376
Email
Abdidoc22@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
No - There is not 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
Comparison effect of Ketamine and Midazolam versus Propofol and Midazolam for gastroduodenoscopy in children referred to Bandar Abbas medical centers
When the data will become available and for how long
One year after the publication of the article
To whom data/document is available
Authors and officials of Hormozgan University of Medical Sciences
Under which criteria data/document could be used
For use in statistical work and larger studies
From where data/document is obtainable
To the first author
What processes are involved for a request to access data/document
Email the first author and request the use of the data