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

Sponsor

Chaudhry Pervaiz Elahi Institute of Cardiology (Other)

Overall Status

Recruiting

CT.gov ID

NCT05004545

Collaborator

(none)

126

Enrollment

Location

Arms

54.7

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hemodynamic Instability	Drug: Propofol	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

126 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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.

Actual Study Start Date :

Jun 10, 2017

Anticipated Primary Completion Date :

Sep 20, 2021

Anticipated Study Completion Date :

Dec 30, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Lactate level will be measured during CPB for CABG patients to see the hemodynamics parameters [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

CABG

Exclusion Criteria:

Emergency surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cardiac Surgery ICU	Multan	Punjab	Pakistan	66100

Sponsors and Collaborators

Chaudhry Pervaiz Elahi Institute of Cardiology

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Muhammad Imran Khan, Principal investigator, Chaudhry Pervaiz Elahi Institute of Cardiology

ClinicalTrials.gov Identifier:

NCT05004545

Other Study ID Numbers:

CPEIC-06

First Posted:

Aug 13, 2021

Last Update Posted:

Aug 13, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Muhammad Imran Khan, Principal investigator, Chaudhry Pervaiz Elahi Institute of Cardiology

Propofol

Sevoflurane

hemodynamic stability

Lactate level

Additional relevant MeSH terms:

Propofol

Study Results

No Results Posted as of Aug 13, 2021