Comparison of Propofol Based Versus Volatile Based Anesthesia and Postoperative Sedation

Study Overview
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Brief Summary
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All patients undergoing cardiac surgery require intraoperative anesthesia and short-term postoperative sedation with anesthetic agents after the procedure when patient is in the intensive care unit (ICU). The clinical data obtained so far are concentrating on intraoperative use volatile agents (preconditioning) resulting in better postoperative cardiac function and less release of biochemical markers of myocardial damage. There are no studies investigating whether postoperative use of volatile agents (post conditioning) in cardiac surgical population is improving outcomes. The aim of the present study is to compare total intravenous anesthesia and postoperative sedation versus total volatile anesthesia and postoperative sedation in cardiac surgical population.

Official Title
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Comparison of Propofol Based Anesthesia and Postoperative Sedation (PA) Versus Volatile Anesthetics Based Anesthesia and Postoperative Sedation (VA) in Cardiac Surgical Patients

Conditions
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Cardiac Surgery

Intervention / Treatment
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* Drug: Isoflurane/sevoflurane
* Other: Propofol


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients scheduled for coronary artery bypass graft surgery with good ventricular function (grade 1-2 ventricle) Signed informed consent Exclusion criteria: Patients undergoing valvular surgery Severe kidney or liver disease (creatinine > 2.5mg.dL-1 and bilirubin > 2 mg.dL-1) Patients with known hypersensitivity to any of the trial drugs (propofol, volatile anesthetics), e.g. propofol allergy or malignant hyperthermia (induced by volatile anesthetics) Patient with poorly controlled diabetes or on oral anti-diabetic medication (inhibit preconditioning caused by volatile anesthetics)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PA-Intravenous Sedation<br>Propofol based total intravenous anesthesia and postoperative sedation | Other: Propofol<br>* Propofol for sedation in the CVICU<br>* Other names: Diprivan;|
| Active Comparator: Volatile sedation<br>Total inhalational anesthesia and postoperative sedation with the AnaConda device | Drug: Isoflurane/sevoflurane<br>* Volatile for sedation in the CVICU while intubated<br>* Other names: 2,2,2-trifluoro-1-[trifluoromethyl]ethyl fluoromethyl ether;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The composite primary end point of the trial will be the development of enzymatic signs of myocardial injury or MI, postoperative low output syndrome, or both. Enzymatic MI will be determined after obtaining serial measurements of troponin. |  | Measurements of troponin levels will be after induction of anesthesia (baseline) and at 0, 2, 4, 8, and 24 h after arrival into the ICU. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of sedation |  | Post ICU arrival POD 0 to discharge (2hours to on average 5-7 days until discharge) | 
| Incidence of delirium |  | Post ICU arrival POD 0 to discharge (2hours to on average 5-7 days until discharge) | 
| Time to readiness for extubation, time to extubation |  | Post ICU arrival POD 0 to discharge (2hours to on average 5-7 days until discharge) | 
| Length of stay within ICU, readiness for discharge from the unit |  | Post ICU arrival POD 0 to discharge (2hours to on average 5-7 days until discharge) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Surgery, Sedation, Intensive care, Volatile anesthesia, Intravenous anesthesia, Pre and post conditioning after cardiac surgery