]>
IRCT20170516033992N13 IRCT 2023-03-30 Oroumia University of Medical Sciences Comparison of the effects of propofol - ketamine and propofol- fentanyl drug regimens on sedation in endoscopy Comparison of the effects of propofol - ketamine and propofol- fentanyl drug regimens on sedation in children undergoing upper endoscopy 2023-05-22 anticipated 50 Complete https://irct.ir/trial/69311 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, 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 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. 3 Sedation during endoscopy. Intervention 1: 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. Intervention 2: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is Not applicable
public Dr.Tohid Karami
Shahid Motahhari hospital., Kashani Ave, Urmia, Iran.
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3223 7077 karami.t@umsu.ac.ir Oroumia University of Medical Sciences scientific Dr.Tohid Karami
Shahid Motahhari hospital., Kashani Ave., Urmia., Iran.
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3223 7077 karami.t@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) Children undergoing upper endoscopy Age between 1-10 years 1 year 10 years Both Emergency endoscopies Patients who do not fast for 6 hours. Patients with a disease history such as cerebral palsy or neuromuscular disorders T88.52 Failed moderate sedation during procedure Treatment - Other Treatment - Other 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. 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. Sedation score. Timepoint: During endoscopy. Method of measurement: Evaluation by the endoscopist. Recovery time. Timepoint: After induction of anesthesia. Method of measurement: Minute. Need for additional anesthesia drug. Timepoint: After induction of anesthesia. Method of measurement: No/yes. Oroumia University of Medical Sciences Approved 2023-02-01 Ethics Committee of Urmia University of Medical Sciences Urmia University of Medical Sciences, Resalat street, Jahad Blvd., Urmia, Iran. Urmia West Azarbaijan Iran (Islamic Republic of)