Propofol vs Sevoflurane in Cardiac Surgery

Propofol vs Sevoflurane in Cardiac Surgery: a Randomized Clinical Trial During the Peroperative and Postoperative Phase

The hypothesis of our study: presence of a relationship between the type of anesthesia and complications after cardiac surgery. The aim is to assess the benefit of using intravenous or inhaled anesthesia on the patients' stay and its complications.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiac Surgery; Cardiac Complications; Respiratory Complications; Neurologic Complications
• Intervention / Treatment: Drug: sedation using propofol; Drug: sedation using sevoflurane

Detailed Description

Cardiac surgery presents unique challenges for anesthesiologists as they are responsible for amnesia, analgesia, muscle relaxation, and maintenance of organ functions in the context of CPB-induced pathophysiological changes. Postoperative complications are vast and varied, leading to a prolonged stay in cardiac intensive care. However, the question of the superiority of one anesthesia protocol over another in cardiac surgery is debated.

The AHA (American Heart Association) recommended the use of inhalation anesthesia to reduce the risk of perioperative myocardial ischemia and infarction in 2011. However, in 2019, this recommendation lost a step in its level of proof and therefore the debate is still open.

Indeed, a "MYRIAD" study carried out on five continents determined that the administration of a halogenated volatile agent provided clinical benefit to patients undergoing coronary revascularization surgery. The study was randomized, single-blind, multicenter, carried out on patients scheduled for coronary bypass surgery with or without extracorporeal circulation (ECB).

Volatile halogenated agents (AVH) have cardioprotective properties via a pre- and post-conditioning phenomenon. Several meta-analyses have shown a benefit from the use of AVH during coronary surgery and in particular a reduction in mortality.

Note that the choice of type of anesthesia is made according to the habits of the department and the anesthetist and is in no way linked to the patient's condition or the intervention.

Given that within the HDF, there is an operating room and an intensive care unit dedicated to cardiac surgery forming an expertise and reference cell in Lebanon, it would be logical to introduce this sedation technique in order to establish new national recommendations and to report the Lebanese experience internationally. The ultimate goal is to provide the patient with optimal perioperative care.

The hypothesis of our study is that there is a relationship between the type of anesthesia and complications after cardiac surgery.

A prospective single-center randomized study targeting patients admitted to cardiovascular and thoracic intensive care for cardiac surgeries (PAC and valve replacement) at the Hôtel-Dieu de France, with the aim of evaluating the benefit of using intravenous anesthesia or inhaler on the patient stay and its complications. Two groups of patients will be formed respecting common characteristics in each group. Each sample of 50 patients will receive one type of anesthesia. All cases meeting the inclusion criteria mentioned below and spanning from 2023 to 2024 will be included in this study. Data collection will be done from the files of the patients concerned during their stay in the hospital intensive care unit.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah Harb, MD; Phone Number: +96171811646; Email: sarah.harb@net.usj.edu.lb
• Study Contact Backup: Name: Khalil Jabbour, MD; Phone Number: +96170009060; Email: khaliljabbour@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• all patients above 18 yeras old that will undergo a cardiac surgery

Exclusion Criteria:

• below 18 yeras old

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: sedation using propofol; this group will include all patients who will receive propofol during the cardiac surgery and afterwards in the intensive care unit during the post operative phase	Drug: sedation using propofol; The different complications studied will be for example respiratory, neurologic and cardiac based on several clinical and biological parameters.
Active Comparator: sedation using sevoflurane; this group will include all patients who will receive sevoflurance druing the cardiac surgery and afterwards in the intensive care unit during the postoperative phase	Drug: sedation using sevoflurane; The differents complications studied will be for example respiratory, neurologic and cardiac based on severl clinical and biological parameters.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
determine the relationship between myocardial protection and type of anesthesia	troponin T dosage	48 hours after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association between the type of anesthesia and the speed of awakening	time taken to respond to simple commands, time elapsed to resume spontaneous ventilation	48 hours after the surgery
Association between the length of stay in intensive care and the type of anesthesia	duration of mechanical ventilation,	72 hours after the surgery
Determine a relationship between the type of anesthesia and the hemodynamic profile	measure cardiac output, vascular and pulmonary resistance, need for vasoamines	48 hours after the surgery
Association between the type of anesthesia and pulmonary complications	pulmonary complications: atelectasis, pneumonia, use of mechanical ventilation	72 hours after the surgery
Association between the type of anesthesia and neurological complications	early and late strokes, confusion, late and early strokes	72 hours after the surgery

Collaborators and Investigators

• Sponsor: Saint-Joseph University

Study record dates

Study Major Dates

• Study Start (Estimated): January 4, 2025
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: September 27, 2024
• First Submitted That Met QC Criteria: December 9, 2024
• First Posted (Estimated): December 11, 2024

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 9, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: complications; postoperative; randomized clinical trial; peroperative; propofol vs sevoflurane in cardiac surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anesthetics; Central Nervous System Depressants; Platelet Aggregation Inhibitors; Hypnotics and Sedatives; Anesthetics, Intravenous; Anesthetics, General; Anesthetics, Inhalation; Sevoflurane; Propofol
• Other Study ID Numbers: CEHDF2230

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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