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

NCT05290324 | Completed

• 1 other identifier: CPEIC22
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

coronary artery bypass graft; midazolam; propofol

Outcome Measures

Primary Outcomes (2)

• Duration of post-surgery sedation

  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 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

Study Arms (2)

MIdazolam Group

EXPERIMENTAL

Following surgery Immediately after shifting in ICU, midazolam infusion were administered as 0.25 mg/kg/min.

Drug: Midazolam

Propofol Group

NO INTERVENTION

Following surgery after Immediately shifting in ICU propofol infusion was started at 10µg/kg/min.

Interventions

Midazolam DRUG

Midazolam infusion will be given after the surgery as 0.25 mg/kg/min.

Also known as: Versed

MIdazolam Group

Eligibility Criteria

• Age: 20 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chaudhry Pervaiz Elahi Institute of Cardiology: lead

Study Sites (1)

Ch. Pervaiz Elahi Institute of Cardiology

Multan, Punjab Province, 59341, Pakistan

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Shumaila Rai, MBBS

  Ch. Pervaiz Elahi Institute of Cardiology, Multan, Pakisan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Open label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Radomized Controlled Trial

Study Record Dates

• First Submitted: January 30, 2022
• First Posted: March 22, 2022
• Study Start: February 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: March 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)