Propofol vs Sevoflurane in Cardiac Surgery

Saint-Joseph University

Status: Not yet enrolling

Conditions: Cardiac Complications; Cardiac Surgery; Respiratory Complications; Neurologic Complications

Treatments: Drug: sedation using propofol; Drug: sedation using sevoflurane

Study type: Interventional

Funder types: Other

Identifiers

NCT06729086

CEHDF2230

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• below 18 yeras old

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

sedation using propofol

Placebo Comparator group

Description:

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

Treatment:

Drug: sedation using propofol

sedation using sevoflurane

Active Comparator group

Description:

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

Treatment:

Drug: sedation using sevoflurane