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Clinical Trials/NCT02863861
NCT02863861
Completed
Phase 4

Comparative Study Between Propofol-Ketamine Combination and Dexmedetomidine-Ketamine Combination for Sedation in Upper Gastrointestinal Endoscopy in Paediatric Patients.

Ain Shams University1 site in 1 country120 target enrollmentSeptember 2016

Overview

Phase
Phase 4
Intervention
propofol-ketamine
Conditions
Upper Gastrointestinal Endoscopy
Sponsor
Ain Shams University
Enrollment
120
Locations
1
Primary Endpoint
length of stay in PACU
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2016
End Date
December 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Akram Mohamed Mohamed Amer

Lecturer in Department of Anesthesiology, Intensive Care, and Pain Management, Faculty of Medicine, Ain-Shams University

Ain Shams University

Eligibility Criteria

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.

Arms & Interventions

Group PK

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.

Intervention: propofol-ketamine

Group DK

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

Intervention: Dexmedetomidine-ketamine

Outcomes

Primary Outcomes

length of stay in PACU

Time Frame: three months

Study Sites (1)

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