Comparison of the effects of propofol - ketamine and propofol- fentanyl drug regimens on sedation in children undergoing upper endoscopy
Design
A double-blind, randomized clinical trial study with parallel groups and phases 3 on 50 patients. Randomization will be done with the block randomization method using Random allocation software.
Settings and conduct
In this study, children aged 1 to 10 who are candidates for upper endoscopy at Urmia Motahari Hospital will be included. This study will be a double-blind study and the patient and the researcher who will evaluate the outcomes will be blinded to the allocation of patients into groups.
Participants/Inclusion and exclusion criteria
In this study, 50 children aged 1-10 years who are candidates for upper endoscopy will be included. Emergency endoscopies, patients who do not fast for 6 hours and patients with a disease history such as cerebral palsy or neuromuscular disorders will be excluded from the study.
Intervention groups
In the first group, induction of anesthesia will be performed with 0.05 mg/kg of midazolam, 1 mg/kg of propofol, 1 mg/kg of ketamine and 0.02 mg/kg of atropine and in the second group, the induction of anesthesia will be performed with 0.05 mg/kg of midazolam, 1 mg/kg of propofol, 2 mcg/kg of fentanyl and 0.02 mg/kg of atropine, and then the patients in both groups will be placed in the left lateral decubitus position and upper gastrointestinal endoscopy will be performed by pediatric gastroenterologist.
Main outcome variables
Sedation score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170516033992N13
Registration date:2023-03-30, 1402/01/10
Registration timing:prospective
Last update:2023-03-30, 1402/01/10
Update count:0
Registration date
2023-03-30, 1402/01/10
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3222 2010
Email address
karami.t@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-09-22, 1402/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of propofol - ketamine and propofol- fentanyl drug regimens on sedation in children undergoing upper endoscopy
Public title
Comparison of the effects of propofol - ketamine and propofol- fentanyl drug regimens on sedation in endoscopy
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Children undergoing upper endoscopy
Age between 1-10 years
Exclusion criteria:
Emergency endoscopies
Patients who do not fast for 6 hours.
Patients with a disease history such as cerebral palsy or neuromuscular disorders
Age
From 1 year old to 10 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into two groups using block randomization based on generated numbers by Random allocation software. Thus, in this software, first the number of groups and the total number of the sample size will be entered, and then in the block section, the Block randomization method will be implemented. Patients will be allocated to two groups based on generated numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be conducted as a double-blind clinical trial. The patient and The person who will assess the outcomes will be blind to the allocation of patients into two groups. Induction of anesthesia with drug regimens will be done by an anesthesiologist (other than the outcome assessor) and the names of the groups will be coded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Urmia University of Medical Sciences
Street address
Urmia University of Medical Sciences, Resalat street, Jahad Blvd., Urmia, Iran.
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2023-02-01, 1401/11/12
Ethics committee reference number
IR.UMSU.REC.1401.389
Health conditions studied
1
Description of health condition studied
Sedation during endoscopy
ICD-10 code
T88.52
ICD-10 code description
Failed moderate sedation during procedure
Primary outcomes
1
Description
Sedation score
Timepoint
During endoscopy
Method of measurement
Evaluation by the endoscopist
Secondary outcomes
1
Description
Recovery time
Timepoint
After induction of anesthesia
Method of measurement
Minute
2
Description
Need for additional anesthesia drug
Timepoint
After induction of anesthesia
Method of measurement
No/yes
Intervention groups
1
Description
Intervention group: In the first group, induction of anesthesia will be performed with 0.05 mg/kg of midazolam, 1 mg/kg of propofol, 1 mg/kg of ketamine and 0.02 mg/kg of atropine and then the patients will be placed in the left lateral decubitus position and upper gastrointestinal endoscopy will be performed by pediatric gastroenterologist.
Category
Treatment - Other
2
Description
Intervention group: In the second group, the induction of anesthesia will be performed with 0.05 mg/kg of midazolam, 1 mg/kg of propofol, 2 mcg/kg of fentanyl and 0.02 mg/kg of atropine, and then the patients will be placed in the left lateral decubitus position and upper gastrointestinal endoscopy will be performed by pediatric gastroenterologist.