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Propofol vs Sevoflurane in Cardiac Surgery

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06729086
Enrollment
100
Registered
2024-12-11
Start date
2025-01-04
Completion date
2025-05-31
Last updated
2024-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Complications, Cardiac Surgery, Neurologic Complications, Respiratory Complications

Keywords

propofol vs sevoflurane in cardiac surgery, peroperative, postoperative, randomized clinical trial, complications

Brief summary

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

DRUGsedation using propofol

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

DRUGsedation using sevoflurane

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

Sponsors

Saint-Joseph University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* below 18 yeras old

Design outcomes

Primary

MeasureTime frameDescription
determine the relationship between myocardial protection and type of anesthesia48 hours after the surgerytroponin T dosage

Secondary

MeasureTime frameDescription
Association between the type of anesthesia and the speed of awakening48 hours after the surgerytime taken to respond to simple commands, time elapsed to resume spontaneous ventilation
Association between the length of stay in intensive care and the type of anesthesia72 hours after the surgeryduration of mechanical ventilation,
Determine a relationship between the type of anesthesia and the hemodynamic profile48 hours after the surgerymeasure cardiac output, vascular and pulmonary resistance, need for vasoamines
Association between the type of anesthesia and pulmonary complications72 hours after the surgerypulmonary complications: atelectasis, pneumonia, use of mechanical ventilation
Association between the type of anesthesia and neurological complications72 hours after the surgeryearly and late strokes, confusion, late and early strokes

Contacts

Primary ContactSarah Harb, MD
sarah.harb@net.usj.edu.lb+96171811646
Backup ContactKhalil Jabbour, MD
khaliljabbour@hotmail.com+96170009060

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026