Sedation During Pediatric Diagnostic Gastrointestinal Endoscopy Gastrointestinal Endoscopy

Not Applicable

• Conditions: Sedation
• Interventions: Drug: Fentanyl; Drug: Ketamine

• Registration Number: NCT03235609
• Lead Sponsor: Assiut University

Brief Summary

comparison between propofol-fentanyl and propofol-ketamine for sedation in pediatric diagnostic gastrointestinal endoscopy.

Detailed Description

It is a prospective double blinded controlled study that will be carried out on 60 pediatric patients undergoing GIT endoscopy; they will be divided into two groups of 30 patients each:- Group I (PF): will receive 0.5 µg/ kg fentanyl + 2 mg/ kg propofol IV. Group II (KF): will receive Ketofol (1 ketamine: 4 propofol) 0.5 mg/kg ketamine + 2 mg/kg propofol IV.

Study Timeline

• Study First Submitted: 2017-07-27
• Study First Submitted QC: 2017-07-31
• Status Verified: 2017-08
• Study First Posted: 2017-08-01
• Last Update Submitted: 2017-08-01
• Last Update Posted: 2017-08-03
• Study Start: 2017-08-16
• Primary Completion: 2018-06-15
• Study Completion: 2018-08-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Pediatric patients undergoing diagnostic GIT endoscopy
• ASA I-II

Exclusion Criteria

• Emergency endoscopy
• Respiratory infection and hyperactive airways
• History of serious adverse effects related to anesthetics (e.g. allergic reactions), a family history of reactions to the study drugs
• Morbid obesity, and neuropsychiatric disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fentanyl	Fentanyl	Group I (FP): will receive 0.5 µg/ kg fentanyl + 2 mg/ kg propofol IV.
Ketamine	Ketamine	Group II (KP): will receive 0.5 mg/kg ketamine + 2 mg/kg propofol IV.

Primary Outcome Measures

Name	Time	Method
incidence of desaturation	up to 2 days after operation	when oxygen saturation below 90%