Propofol Versus Midazolam for Lower Gastrointestinal Endoscopy

August 23, 2018 updated by: Sherief Abd-Elsalam

Effect of Use of Propofol Versus Use of Midazolam as Sedative Agent in Patients With Liver Cirrhosis Presented for Lower Gastrointestinal Endoscopy, Randomised Controlled Trial

propofol versus use of midazolam as sedative agent in patients with liver cirrhosis presented for lower gastrointestinal endoscopy

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Effect of use of propofol versus use of midazolam as sedative agent in patients with liver cirrhosis presented for lower gastrointestinal endoscopy, Randomised controlled trial.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 3

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
      • Tanta, Egypt
        • Recruiting
        • Sherief Abd-Elsalam

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

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Liver cirrhosis
  • presented to colonoscopy

Exclusion Criteria:

  • Encephalopathy
  • Hypersensitivity
  • Coagulopathy

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
Active Comparator: Midazolam
Midazolam 3 mg i.v added to fentanyl 0.5 ug/kg till reaching satisfactory level of sedation
Drug: Midazolam
Midazolam 3 mg i.v added to fentanyl 0.5 ug/kg till reaching satisfactory level of sedation
Active Comparator: Propofol
Propofol 1 mg/kg i.v added to fentanyl 0.5 ug/kg i.v till reaching satisfactory level of sedation
Drug: Propofol
Propofol 1 mg/kg i.v added to fentanyl 0.5 ug/kg i.v till reaching satisfactory level of sedation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients adequately sedated
Time Frame: 6 months
The number of patients adequately sedated
6 months

Collaborators and Investigators

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

Sponsor

Sherief Abd-Elsalam

Investigators

  • Principal Investigator: Sherief Abd-Elsalam, MD, Gastroenterology
  • Study Director: Sameh Abdelkhalek Ahmed, MD, Tanta University Anasthesia Department

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)

April 1, 2016

Primary Completion (Anticipated)

November 11, 2022

Study Completion (Anticipated)

December 11, 2022

Study Registration Dates

First Submitted

December 23, 2017

First Submitted That Met QC Criteria

December 29, 2017

First Posted (Actual)

January 2, 2018

Study Record Updates

Last Update Posted (Actual)

August 27, 2018

Last Update Submitted That Met QC Criteria

August 23, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Propofol colonoscopy

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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