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

Sponsor
Chaudhry Pervaiz Elahi Institute of Cardiology (Other)
Overall Status
Completed
CT.gov ID
NCT05290324
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
12
Actual Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Radomized Controlled TrialRadomized Controlled Trial
Masking:
Single (Participant)
Masking Description:
Open label
Primary Purpose:
Treatment
Official Title:
Propofol or Midazolam for Sedation and Early Extubation Following Coronary Artery Bypass Graft Surgery
Actual Study Start Date :
Feb 1, 2019
Actual Primary Completion Date :
Feb 1, 2020
Actual Study Completion Date :
Feb 1, 2020

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Duration of post-surgery sedation [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

    2. Time taken 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]

      Time taken from the end of cardiac surgery to post-surgery extubation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 20 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ch. Pervaiz Elahi Institute of Cardiology Multan Punjab Pakistan 59341

    Sponsors and Collaborators

    • Chaudhry Pervaiz Elahi Institute of Cardiology

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shumaila rai, Principal Investigator, Chaudhry Pervaiz Elahi Institute of Cardiology
    ClinicalTrials.gov Identifier:
    NCT05290324
    Other Study ID Numbers:
    • CPEIC22
    First Posted:
    Mar 22, 2022
    Last Update Posted:
    Mar 22, 2022
    Last Verified:
    Mar 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
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Shumaila rai, Principal Investigator, Chaudhry Pervaiz Elahi Institute of Cardiology
    coronary artery bypass graft
    midazolam
    propofol
    Additional relevant MeSH terms:
    Coronary Artery Disease
    Midazolam

    Study Results

    No Results Posted as of Mar 22, 2022