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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00376831

Enrollment

Registered

2006-09-15

Start date

2007-01-31

Completion date

2007-06-30

Last updated

2007-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonoscopy, Conscious Sedation

Keywords

colonoscopy, conscious sedation, midazolam, ketamine, fentanyl

Brief 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.

Interventions

DRUGMidazolam, Fentanyl

fentanyl 0.07 mcg/kg + midazolam 0.05 mg/kg if needed adding midazolam up to a total of 0.1 mg/kg

DRUGKETAMINE, MIDAZOLAM

Ketamine 0.25 mg/kg + midazolam 0.05 mg/kg if needed adding midazolam up to a total of 0.1 mg/kg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Recovery time	24 hours following colonoscopy

Secondary

Measure	Time frame
Sedative effect	24 hours following colonoscopy
Patient compliance	24 hours following colonoscopy
Side effects	24 hours following colonoscopy

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026