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NCT00376831 Clinical Trial

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

Colonoscopy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00376831
Other study ID # SOR440806CTIL
Secondary ID
Status Completed
Phase Phase 4
First received September 14, 2006
Last updated August 9, 2007
Start date January 2007
Est. completion date June 2007

Study information
Verified date August 2007
Source Soroka University Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 91
Est. completion date June 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Midazolam, Fentanyl
fentanyl 0.07 mcg/kg + midazolam 0.05 mg/kg if needed adding midazolam up to a total of 0.1 mg/kg
• KETAMINE, MIDAZOLAM
Ketamine 0.25 mg/kg + midazolam 0.05 mg/kg if needed adding midazolam up to a total of 0.1 mg/kg

Locations
Country Name City State
Israel Soroka Medical Center Beer Sheva

Sponsors (1)
Lead Sponsor Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Recovery time 24 hours following colonoscopy
Secondary Sedative effect 24 hours following colonoscopy
Secondary Patient compliance 24 hours following colonoscopy
Secondary Side effects 24 hours following colonoscopy
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