Compare Hemodynamic Parameters of Propofol and Sevoflurane During CPB Time in Undergoing CABG to Avoid Lactate Level

August 9, 2021 updated by: Muhammad Imran Khan, Chaudhry Pervaiz Elahi Institute of Cardiology

To Compare Hemodynamic Parameters of Propofol and Sevoflurane During Cardiopulmonary Bypass Time in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery to Avoid Lactate Level.

Hemodynamic parameters and lactate level will be on CBP during CABG surgery patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Objective: To compare hemodynamic parameters of propofol and sevoflurane during cardiopulmonary bypass time in patients undergoing coronary artery bypass graft (CABG) surgery to avoid lactate level.

Methods: One hundred and twenty six patients scheduled for CABG from May 2017 to May 2018 will be included in this study. Non probability consecutive sampling will be used. Patients will be divided in two groups, propofol will be given to group 1, and sevoflurane will be given to group 2. Age, clamp time, bypass time, mean arterial blood pressure on bypass machine and lactate level will be compared between two groups. SPSS version 24 will used and p value ≤ 0.05 will be considered as significant.

Study Type

Interventional

Enrollment (Anticipated)

126

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 Contact

Study Locations

  • Pakistan
    • Punjab
      • Multan, Punjab, Pakistan, 66100
        • Recruiting
        • Cardiac Surgery ICU
        • Contact:
          • Kneez Ume Farwa, FCPS
        • Principal Investigator:
          • Kaneez Ume Farwa, FCPS

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 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

CABG

Exclusion Criteria:

Emergency surgery

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group 1 Profol Infusion to CABG patients to check lactate level
Propofol infusion according to bodyweight will be given to check lactate level on CPB
Drug: Propofol
Propofol infusion according to body weight will be compared with sevoflurane acording to MAC % to see the lactate level and hemodynamic parameters of CABG patients
Active Comparator: sevoflurane will be given to group 2 to check lacate level
Sevoflurane MAC % will be given to CABG patients to check lactate level
Drug: Propofol
Propofol infusion according to body weight will be compared with sevoflurane acording to MAC % to see the lactate level and hemodynamic parameters of CABG patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lactate level will be measured during CPB for CABG patients to see the hemodynamics parameters
Time Frame: 06 months
The mean pre-cross clamp lactate level and post- rewarming lactate level will be calculated to see the effect of this on the CABG patients hemodynamics during CBP
06 months

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: Kaneez Ume Farwa, FCPS, Chaudhry Pervaiz Elahi Institute of Cardiology

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)

June 10, 2017

Primary Completion (Anticipated)

September 20, 2021

Study Completion (Anticipated)

December 30, 2021

Study Registration Dates

First Submitted

July 16, 2021

First Submitted That Met QC Criteria

August 9, 2021

First Posted (Actual)

August 13, 2021

Study Record Updates

Last Update Posted (Actual)

August 13, 2021

Last Update Submitted That Met QC Criteria

August 9, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPEIC-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Ok

IPD Sharing Time Frame

Soon

IPD Sharing Access Criteria

Ok

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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.

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