Propofol vs Sevoflurane in Cardiac Surgery

NCT ID: NCT06729086

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-04

Study Completion Date

2025-05-31

Brief Summary

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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

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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.

Conditions

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Cardiac Complications Cardiac Surgery Neurologic Complications Respiratory Complications

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type PLACEBO_COMPARATOR

sedation using propofol

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

sedation using sevoflurane

Intervention Type DRUG

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

Interventions

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sedation using propofol

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

Intervention Type DRUG

sedation using sevoflurane

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* below 18 yeras old
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saint-Joseph University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Sarah Harb, MD

Role: CONTACT

Phone: +96171811646

Email: [email protected]

Khalil Jabbour, MD

Role: CONTACT

Phone: +96170009060

Email: [email protected]

Other Identifiers

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CEHDF2230

Identifier Type: -

Identifier Source: org_study_id