Dexmedetomidine Versus Ketamine Versus Midazolam in Endoscopic Procedures

Ketamine

Brief Summary

This study aims to assess the safety and efficacy of dexmedetomidine versus ketamine versus midazolam combined with propofol in cancer patients undergoing gastrointestinal endoscopic procedures.

Intervention / Treatment

  • Dexmedetomidine (DRUG)
    intravenous dexmedetomidine 1 mic/kg
  • Ketamine (DRUG)
    ketamine 1mg/kg
  • Midazolam (DRUG)
    midazolam 0.05 mg/kg

Condition or Disease

  • Sedation and Analgesia

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 70 Years
    Enrollment: 75 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    DOUBLE:
    • Participant
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Nov 01, 2020 ACTUAL
    Primary Completion: Dec 15, 2022 ACTUAL
    Completion Date: Dec 30, 2022 ACTUAL
    Study First Posted: Oct 22, 2020 ACTUAL
    Last Updated: Jan 08, 2023

    Sponsors / Collaborators

    Lead Sponsor: National Cancer Institute, Egypt
    Responsible Party: N/A

    Location

    Cairo, Egypt

    Comparison between using intravenous (IV) propofol combined with either IV dexmedetomidine or IV ketamine or IV midazolam; to study the effect of their combination on level of sedation and hemodynamic stability on adult patients scheduled for gastrointestinal endoscopic procedures.

    Participant Groups

    • IV dexmedetomidine

    • IV ketamine

    • IV midazolam

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 70
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * patients scheduled for gastrointestinal endoscopic procedures
    * ≥ Age 18 years
    * ASA I-II

    Exclusion Criteria:

    * Allergy to any of the used drugs
    * impaired renal or liver functions
    * hypertensive patients
    * patients with cardiovascular
    * cerebrovascular disease

    Primary Outcomes

    • time to achievement of Ramsy sedation score (RSS) 3-4, Ramsy sedation scale score from 1 to 6, 1 meaning anxious and 6 meaning no response to stimulus

    More Details

    NCT Number: NCT04597268
    Other IDs: AP2007-50110
    Study URL: https://clinicaltrials.gov/study/NCT04597268
    Last updated: Sep 29, 2023