The Efficacy of Midazolam & Ketamine Versus Midazolam & Fentanyl for Sedation in Ambulatory Colonoscopies
Information source: Soroka University Medical Center
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Colonoscopy; Conscious Sedation
Intervention: Midazolam, Fentanyl (Drug); KETAMINE, MIDAZOLAM (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Soroka University Medical Center Official(s) and/or principal investigator(s):
pavel krugliak, md. professor, Principal Investigator, Affiliation: Head of the endoscopic unit at Soroka Medical Center Beer Sheva Israel
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.
Clinical Details
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Recovery time
Secondary outcome: Sedative effectPatient compliance Side effects
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Candidates for elective colonoscopy at the Soroka Medical Center who have signed an
informed consent.
Exclusion Criteria:
1. Hypersensitivity to benzodiazepines
2. Hypersensitivity to benzyl alcohol
3. Hypersensitivity to ketamine
4. Hypersensitivity to opiates
5. Pregnancy
6. Uncontrolled hypertension
7. Myocardial infarct in the last 6 months
8. CVA
9. Chronic pulmonary disease
10. Renal failure
11. Chronic liver disease (CHILD B or C)
12. Elevated ICP, cerebral hemorrhage or cranial SOL.
13. Hypovolemic shock
14. Glaucoma
15. Mental illness
16. Drug or alcohol addiction
Locations and Contacts
Soroka Medical Center, beer sheva 84101, Israel
Additional Information
Starting date: January 2007
Ending date: June 2007
Last updated: August 9, 2007
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