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Not yet recruitingNCT06729086Updated Dec 11, 2024

Propofol vs Sevoflurane in Cardiac Surgery

An interventional study of sedation using propofol and sedation using sevoflurane in Cardiac Complications, Cardiac Surgery and Neurologic Complications, sponsored by Saint-Joseph University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-11.

Sponsored by Saint-Joseph University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 6 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cardiac Complications
  • Cardiac Surgery
  • Neurologic Complications
  • Respiratory Complications

Keywords

  • propofol vs sevoflurane in cardiac surgery
  • peroperative
  • postoperative
  • randomized clinical trial
  • complications
03

In context

Lead sponsor

Saint-Joseph University is the lead sponsor of 71 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • below 18 yeras old
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
100 participants (estimated)

Study arms

  • Placebo comparator
    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

    Drug: sedation using propofol

  • Active comparator
    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

    Drug: sedation using sevoflurane

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.

06

What researchers measure

Primary outcomes

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

    troponin T dosage

    Time frame: 48 hours after the surgery

Secondary outcomes

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

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

    Time frame: 48 hours after the surgery

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

    duration of mechanical ventilation,

    Time frame: 72 hours after the surgery

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

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

    Time frame: 48 hours after the surgery

  4. Association between the type of anesthesia and pulmonary complications

    pulmonary complications: atelectasis, pneumonia, use of mechanical ventilation

    Time frame: 72 hours after the surgery

  5. Association between the type of anesthesia and neurological complications

    early and late strokes, confusion, late and early strokes

    Time frame: 72 hours after the surgery

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06729086
Lead sponsor
Saint-Joseph University
Responsible party
Sponsor
First posted
Dec 11, 2024
Start date
Jan 4, 2025 (estimated)
Primary completion
Mar 31, 2025 (estimated)
Completion
May 31, 2025 (estimated)
Last update
Dec 11, 2024

Study contacts

Sarah Harb, MD
Contact
sarah.harb@net.usj.edu.lb
+96171811646
Khalil Jabbour, MD
Contact
khaliljabbour@hotmail.com
+96170009060

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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