Sedation for Upper Gastrointestinal Endoscopy in Pediatric Patients

Phase 4

Completed

• Conditions: Upper Gastrointestinal Endoscopy
• Interventions: Drug: propofol-ketamine; Drug: Dexmedetomidine-ketamine

• Registration Number: NCT02863861
• Lead Sponsor: Ain Shams University

Brief Summary

The purpose of this study is to compere between Propofol-Ketamine combination and Dexmedetomidine-Ketamine combination for sedation in upper gastrointestinal endoscopy in paediatric patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-08
• Study First Submitted QC: 2016-08-10
• Study First Posted: 2016-08-11
• Study Start: 2016-09
• Status Verified: 2016-12
• Primary Completion: 2016-12
• Last Update Submitted: 2016-12-21
• Last Update Posted: 2016-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• American Society of Anesthesiologists ASA I-II patients aging 2-7 years.

Exclusion Criteria

known allergy to any of the study drugs, significant cardiovascular disease vomiting.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group PK	propofol-ketamine	Propofol-Ketamine group: patients in this group will receive IV ketamine at a dose of 1mg.kg-1 in addition to IV propofol 1mg.kg-1 for induction with added doses of propofol 1mg.kg-1 when needed.
Group DK	Dexmedetomidine-ketamine	Dexmedetomidine-Ketamine group: patients in this group will receive IV ketamine at a dose of 1mg.kg-1 in addition to IV dexmedetomidine 0.5 mcg.kg-1 for induction with additional doses of dexmedetomidine 0.5mcg.kg-1 when required

Primary Outcome Measures

Name	Time	Method
length of stay in PACU	three months

Trial Locations

Locations (1)

Ain shams university- faculty of medicine- department of anesthesia, intensive care and pain management; 🇪🇬 Cairo, Egypt