Dexmedetomidine Versus Ketamine Versus Midazolam in Endoscopic Procedures

January 8, 2023 updated by: Walaa Youssef Elsabeeny, National Cancer Institute, Egypt

Safety and Efficacy of Dexmedetomidine vs Ketamine vs Midazolam Combined With Propofol in Gastrointestinal Procedures for Cancer Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11796
        • Walaa Y Elsabeeny

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ramsy sedation score (RSS)
Time Frame: 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
3 to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute, Egypt

Investigators

  • Study Director: Nahla Y Shehab, MD, lecturer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2020

Primary Completion (Actual)

December 15, 2022

Study Completion (Actual)

December 30, 2022

Study Registration Dates

First Submitted

October 15, 2020

First Submitted That Met QC Criteria

October 15, 2020

First Posted (Actual)

October 22, 2020

Study Record Updates

Last Update Posted (Estimate)

January 10, 2023

Last Update Submitted That Met QC Criteria

January 8, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AP2007-50110

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Data available upon reasonable request through contacting the corresponding author

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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