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NCT02863861 Clinical Trial

Sedation for Upper Gastrointestinal Endoscopy in Pediatric Patients

Upper Gastrointestinal Endoscopy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02863861
Other study ID # FMASU R 12/2016
Secondary ID
Status Completed
Phase Phase 4
First received August 8, 2016
Last updated December 21, 2016
Start date September 2016

Study information
Verified date December 2016
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 2 Years to 7 Years
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver)

Related Conditions & MeSH terms

Intervention

Drug:
• Dexmedetomidine-ketamine

• propofol-ketamine

Locations
Country Name City State
Egypt Ain shams university- faculty of medicine- department of anesthesia, intensive care and pain management Cairo

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary length of stay in PACU three months No
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