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

Soroka University Medical Center

Status and phase: Completed; Phase 4

Conditions: Conscious Sedation; Colonoscopy

Treatments: Drug: Midazolam, Fentanyl; Drug: KETAMINE, MIDAZOLAM

Study type: Interventional

Funder types: Other

Identifiers

NCT00376831

SOR440806CTIL

Details and patient eligibility

About

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.

Enrollment: 91 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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91 participants in 2 patient groups

0

Active Comparator group

Description:

fentanyl

Treatment:

Drug: Midazolam, Fentanyl

1

Active Comparator group

Description:

ketamine

Treatment:

Drug: KETAMINE, MIDAZOLAM