Clinical Trials Directory

Trials / Completed

CompletedNCT00376831

The Efficacy of Midazolam & Ketamine Versus Midazolam & Fentanyl for Sedation in Ambulatory Colonoscopies

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
91 (actual)
Sponsor
Soroka University Medical Center · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Accepted

Summary

Providing adequate sedation and analgesia is an integral part of the practice of colonoscopy procedure. There are various protocols and methods used to prevent discomfort and alleviate pain. Conscious sedation is one of the options recommended by the American Society for Gastrointestinal Endoscopy, although the choice of the exact protocol is left to the physician's discretion. This study will attempt to recommend a preferred protocol based on a double blind randomized prospective method. The efficacy of midazolam and ketamine will be compared to the efficacy of midazolam and fentanyl for sedation in ambulatory colonoscopies. The results will be compiled from objective data and patient and physician interviews.

Conditions

Interventions

TypeNameDescription
DRUGMidazolam, Fentanylfentanyl 0.07 mcg/kg + midazolam 0.05 mg/kg if needed adding midazolam up to a total of 0.1 mg/kg
DRUGKETAMINE, MIDAZOLAMKetamine 0.25 mg/kg + midazolam 0.05 mg/kg if needed adding midazolam up to a total of 0.1 mg/kg

Timeline

Start date
2007-01-01
Completion
2007-06-01
First posted
2006-09-15
Last updated
2007-08-10

Locations

1 site across 1 country: Israel

Source: ClinicalTrials.gov record NCT00376831. Inclusion in this directory is not an endorsement.