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Not yet recruiting NCT06729086

Propofol vs Sevoflurane in Cardiac Surgery

No phase Interventional Cardiac Complications Cardiac Surgery Neurologic Complications Respiratory Complications

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: sedation using propofol, sedation using sevoflurane.
Who it may be relevant to
Registry conditions: Cardiac Complications, Cardiac Surgery, Neurologic Complications, Respiratory Complications. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • Drug sedation using propofol
    The different complications studied will be for example respiratory, neurologic and cardiac based on several clinical and biological parameters.
  • Drug sedation using sevoflurane
    The differents complications studied will be for example respiratory, neurologic and cardiac based on severl clinical and biological parameters.

Primary outcome measures

  • determine the relationship between myocardial protection and type of anesthesia [Time frame: 48 hours after the surgery]
Secondary outcome measures (5)
  • Association between the type of anesthesia and the speed of awakening [Time frame: 48 hours after the surgery]
  • Association between the length of stay in intensive care and the type of anesthesia [Time frame: 72 hours after the surgery]
  • Determine a relationship between the type of anesthesia and the hemodynamic profile [Time frame: 48 hours after the surgery]
  • Association between the type of anesthesia and pulmonary complications [Time frame: 72 hours after the surgery]
  • Association between the type of anesthesia and neurological complications [Time frame: 72 hours after the surgery]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • below 18 yeras old

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06729086 · CEHDF2230

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗