Cardioprotective effect of propofol in cardioplegia compared to systemic propofol in heart valves surgery; a randomized controlled trial

Phase 4

• Conditions: Surgery

• Registration Number: PACTR201907764652028
• Lead Sponsor: Tanta University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-22
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

The study will include all patients subjected to valve replacement or repair due to rheumatic affection.
Those patients will be categorized into three groups:
*Group 1(patients with propofol in the cardioplegia and placebo injection in the aortic line).
*Group 2(patients with propofol injection in the aortic line before and after the aortic cross clamp and placebo injection in the cardioplegia).
*Group 3(patients with placebo injection either in the cardioplegia and aortic line).

Exclusion Criteria

Patients less than 18 years old and more than 70 years old.
Patients with coronary artery disease.
Patients subjected to complex aortic surgery(arch or root surgery).
Patients with allergy to propofol.
Emergency cardiac surgery.
Redo cardiac surgery.
Minimal invasive cardiac surgery.
Non-rheumatic valve pathology.
Patients with end stage renal failure.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiac troponin T level

Secondary Outcome Measures

Name	Time	Method
Echocardiography,liver function test,renal function test,cross clamp time,total bypass time, reperfusion time, recovery time,need for defibrilator, ICU stay and morbidty.