Propofol or Midazolam for Sedation and Early Extubation Following Coronary Artery Bypass Graft Surgery

March 11, 2022 updated by: Shumaila rai, Chaudhry Pervaiz Elahi Institute of Cardiology
Propofol and midazolam are used frequently as sedating agents among patients who undergo coronary artery bypass graft surgery but no study in Pakistan has been done to compare their effectiveness aiming early extubation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Propofol is an intra lipid and alkali phenol chemically it is unrelated to sedative agents or anaesthetic. Midazolam is a banzodiazepen. Most of its properties are similar to diazepam. It is a common practice to use sedatives to provide comfort and decrease "ventilator-asynchrony" in critically ill patients that may require prolonged invasive mechanical ventilation. The other reason to employ sedatives is to reduce the anxiety associated with the inaviseve procedures routinely conducted in the ICU.

Study Type

Interventional

Enrollment (Actual)

60

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

  • Pakistan
    • Punjab
      • Multan, Punjab, Pakistan, 59341
        • Ch. Pervaiz Elahi Institute of Cardiology

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

20 years to 20 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients of American Society of Anesthesiologists (ASA) III who were selected for coronary artery bypass graft surgery.

Exclusion Criteria:

  • History of any psychiatric disease.
  • Using antidepressants
  • Alcohol abusers
  • Obese
  • Pregnant women

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MIdazolam Group
Following surgery Immediately after shifting in ICU, midazolam infusion were administered as 0.25 mg/kg/min.
Drug: Midazolam
Midazolam infusion will be given after the surgery as 0.25 mg/kg/min.
Other Names:
  • Versed
No Intervention: Propofol Group
Following surgery after Immediately shifting in ICU propofol infusion was started at 10µg/kg/min.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of post-surgery sedation
Time Frame: Time in minutes calculated from end of surgery to the time of awakening up to 24 hours in both study groups
Duration of post-surgery sedation following cardiac surgery
Time in minutes calculated from end of surgery to the time of awakening up to 24 hours in both study groups
Time taken to post-surgery extubation
Time Frame: Time taken in minutes from the end of the cardiac surgery to post-surgery extubation up to 1 week duration in both study groups
Time taken from the end of cardiac surgery to post-surgery extubation
Time taken in minutes from the end of the cardiac surgery to post-surgery extubation up to 1 week duration in both study groups

Collaborators and Investigators

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

Sponsor

Chaudhry Pervaiz Elahi Institute of Cardiology

Investigators

  • Principal Investigator: Shumaila Rai, MBBS, Ch. Pervaiz Elahi Institute of Cardiology, Multan, Pakisan

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)

February 1, 2019

Primary Completion (Actual)

February 1, 2020

Study Completion (Actual)

February 1, 2020

Study Registration Dates

First Submitted

January 30, 2022

First Submitted That Met QC Criteria

March 11, 2022

First Posted (Actual)

March 22, 2022

Study Record Updates

Last Update Posted (Actual)

March 22, 2022

Last Update Submitted That Met QC Criteria

March 11, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPEIC22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on Coronary Artery Disease

Clinical Trials on Midazolam

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe