Cardiac ComplicationsNCT06729086
Propofol vs Sevoflurane in Cardiac Surgery
A study testing sedation using propofol and sedation using sevoflurane in people with Cardiac Complications and Cardiac Surgery, run by Saint-Joseph University.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Complications, Cardiac Surgery, Neurologic Complications
- What is being tested?
- sedation using propofol and sedation using sevoflurane
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 4 Jan 2025to 31 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patients above 18 yeras old that will undergo a cardiac surgery
Who cannot join
- below 18 yeras old
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Propofol vs Sevoflurane in Cardiac Surgery: a Randomized Clinical Trial During the Peroperative and Postoperative Phase
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.
- Conditions
- Cardiac Complications, Cardiac Surgery, Neurologic Complications, Respiratory Complications
- Being tested
- sedation using propofol, sedation using sevoflurane
- Keywords
- propofol vs sevoflurane in cardiac surgery, peroperative, postoperative, randomized clinical trial, complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sedation using propofolDrug
The different complications studied will be for example respiratory, neurologic and cardiac based on several clinical and biological parameters.
sedation using sevofluraneDrug
The differents complications studied will be for example respiratory, neurologic and cardiac based on severl clinical and biological parameters.
| Study group | Role | What they receive |
|---|---|---|
| sedation using propofol | Placebo comparator | 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 Receives: Drug: sedation using propofol |
| sedation using sevoflurane | Active comparator | 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 Receives: Drug: sedation using sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
determine the relationship between myocardial protection and type of anesthesia
troponin T dosage
Measured: 48 hours after the surgery
Secondary outcomes (5)
Association between the type of anesthesia and the speed of awakening
time taken to respond to simple commands, time elapsed to resume spontaneous ventilation
Measured: 48 hours after the surgery
Association between the length of stay in intensive care and the type of anesthesia
duration of mechanical ventilation,
Measured: 72 hours after the surgery
Determine a relationship between the type of anesthesia and the hemodynamic profile
measure cardiac output, vascular and pulmonary resistance, need for vasoamines
Measured: 48 hours after the surgery
Association between the type of anesthesia and pulmonary complications
pulmonary complications: atelectasis, pneumonia, use of mechanical ventilation
Measured: 72 hours after the surgery
Association between the type of anesthesia and neurological complications
early and late strokes, confusion, late and early strokes
Measured: 72 hours after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start4 Jan 2025 (estimated)
- Primary completion31 Mar 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint-Joseph University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06729086
- Sponsor's protocol ID
- CEHDF2230
- Status last verified
- Dec 2024
- First submitted
- 27 Sep 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propofol vs Sevoflurane in Cardiac Surgery: a Randomized Clinical Trial During the Peroperative and Postoperative Phase
- ClinicalTrials.gov ID
- NCT06729086
- Acronym / sponsor ID
- CEHDF2230
- Conditions
- Cardiac Complications, Cardiac Surgery, Neurologic Complications, Respiratory Complications
- Keywords
- propofol vs sevoflurane in cardiac surgery, peroperative, postoperative, randomized clinical trial, complications
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Saint-Joseph UniversityUniversity, hospital or other
- Study start
- 4 Jan 2025 (estimated)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sedation using propofol | Placebo comparator | Drug: sedation using propofolthis 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 |
| sedation using sevoflurane | Active comparator | Drug: sedation using sevofluranethis group will include all patients who will receive sevoflurance druing the cardiac surgery and afterwards in the intensive care unit during the postoperative phase |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients above 18 yeras old that will undergo a cardiac surgery
Key exclusion criteria (1 listed)
- below 18 yeras old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sedation using propofolThe different complications studied will be for example respiratory, neurologic and cardiac based on several clinical and biological parameters. | Drug | sedation using propofol |
| sedation using sevofluraneThe differents complications studied will be for example respiratory, neurologic and cardiac based on severl clinical and biological parameters. | Drug | sedation using sevoflurane |
Primary outcome
determine the relationship between myocardial protection and type of anesthesia
Time frame: 48 hours after the surgery
troponin T dosage
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing sedation using propofol and sedation using sevoflurane in people with Cardiac Complications and Cardiac Surgery, run by Saint-Joseph University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Harb, MD (+96171811646, sarah.harb@net.usj.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
determine the relationship between myocardial protection and type of anesthesia (time frame: 48 hours after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.