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

Ketamine

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.

Intervention / Treatment

  • Midazolam, Fentanyl (DRUG)
    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 (DRUG)
    Ketamine 0.25 mg/kg + midazolam 0.05 mg/kg if needed adding midazolam up to a total of 0.1 mg/kg

Condition or Disease

  • Colonoscopy
  • Conscious Sedation

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 75 Years
    Enrollment: 91 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    TRIPLE:
    • Participant
    • Care Provider
    • Investigator

    Clinical Trial Dates

    Start date: Jan 01, 2007
    Primary Completion: Aug 31, 2020
    Completion Date: Jun 01, 2007 ACTUAL
    Study First Posted: Sep 15, 2006 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Aug 09, 2007

    Sponsors / Collaborators

    Lead Sponsor: Soroka University Medical Center
    Responsible Party: N/A
    No responsible party listed

    Location

    Beer Sheva, Israel

    Participant Groups

    • fentanyl

    • ketamine

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 75
    Age Groups: Adult / Older Adult
    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

    Primary Outcomes
    • Recovery time 24 hours following colonoscopy
    Secondary Outcomes
    • Sedative effect 24 hours following colonoscopy
    • Patient compliance 24 hours following colonoscopy
    • Side effects 24 hours following colonoscopy

    More Details

    NCT Number: NCT00376831
    Other IDs: SOR440806CTIL
    Study URL: https://clinicaltrials.gov/study/NCT00376831
    Last updated: Sep 29, 2023