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Dexmedetomidine Versus Ketamine Versus Midazolam in Endoscopic Procedures

Sponsor
National Cancer Institute, Egypt (Other)
Overall Status
Recruiting
CT.gov ID
NCT04597268
Collaborator
(none)
75
Enrollment
1
Location
3
Arms
21.7
Anticipated Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Safety and Efficacy of Dexmedetomidine vs Ketamine vs Midazolam Combined With Propofol in Gastrointestinal Procedures for Cancer Patients
Actual Study Start Date :
Nov 1, 2020
Anticipated Primary Completion Date :
Aug 10, 2022
Anticipated Study Completion Date :
Aug 25, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: dexmedetomidine

IV dexmedetomidine

Drug: Dexmedetomidine
intravenous dexmedetomidine 1 mic/kg
Other Names:
  • propofol- dexmedetomidine

    		•
    Experimental: ketamine

    IV ketamine

    Drug: Ketamine
    ketamine 1mg/kg
    Other Names:
  • propofol- ketamine

    		•
    Active Comparator: Midazolam

    IV midazolam

    Drug: Midazolam
    midazolam 0.05 mg/kg
    Other Names:
  • propofol- midazolam

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Ramsy sedation score (RSS) [3 to 6 months]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Walaa Y Elsabeeny Cairo Egypt 11796

    Sponsors and Collaborators

    • National Cancer Institute, Egypt

    Investigators

    • Principal Investigator: Walaa Y Elsabeeny, MD, Lecturer
    • Study Director: Nahla Y Shehab, MD, Lecturer

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Walaa Youssef Elsabeeny, Lecturer of anesthesia and pain management, National Cancer Institute, Egypt
    ClinicalTrials.gov Identifier:
    NCT04597268
    Other Study ID Numbers:
    • AP2007-50110
    First Posted:
    Oct 22, 2020
    Last Update Posted:
    Jun 21, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Midazolam
    Dexmedetomidine
    Ketamine
    Propofol

    Study Results

    No Results Posted as of Jun 21, 2022