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NCT Number: NCT06729086

Propofol vs Sevoflurane in Cardiac Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • below 18 yeras old

Treatment and study plan

sedation using propofol

Drug

The different complications studied will be for example respiratory, neurologic and cardiac based on several clinical and biological parameters.

sedation using sevoflurane

Drug

The differents complications studied will be for example respiratory, neurologic and cardiac based on severl clinical and biological parameters.

Primary outcomes

  1. determine the relationship between myocardial protection and type of anesthesia

    Time frame: 48 hours after the surgery

    troponin T dosage

Secondary outcomes

  1. Association between the type of anesthesia and the speed of awakening

    Time frame: 48 hours after the surgery

    time taken to respond to simple commands, time elapsed to resume spontaneous ventilation

  2. Association between the length of stay in intensive care and the type of anesthesia

    Time frame: 72 hours after the surgery

    duration of mechanical ventilation,

  3. Determine a relationship between the type of anesthesia and the hemodynamic profile

    Time frame: 48 hours after the surgery

    measure cardiac output, vascular and pulmonary resistance, need for vasoamines

  4. Association between the type of anesthesia and pulmonary complications

    Time frame: 72 hours after the surgery

    pulmonary complications: atelectasis, pneumonia, use of mechanical ventilation

  5. Association between the type of anesthesia and neurological complications

    Time frame: 72 hours after the surgery

    early and late strokes, confusion, late and early strokes

Study contacts

Contact information is provided by the study sponsor or research team.

Khalil Jabbour, MD

CONTACT

[email protected]

+96170009060

Sarah Harb, MD

CONTACT

[email protected]

+96171811646

Sponsors and collaborators

Lead sponsor

Saint-Joseph University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 11, 2024
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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