Remifentanil/Sufentanil for CABG+/-AVR Evaluated by Recovery, Cognitive Function, Haemodynamics and Biochemical Markers.

Study Overview
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Brief Summary
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To evaluate the effect on cognitive function, recovery, cardioprotection and haemodynamics of standard Remifentanil anaesthesia to standard Sufentanil anaesthesia in patients undergoing coronary artery bypass with or without aortic valve replacement.

Detailed Description
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Haemodynamic effects, evaluated by invasive haemodynamic data (arterial line and PAC) of opioid given as single drug and in combination with Propofol (first 30 patients only). Cognitive dysfunction evaluated by standard test preoperative and postoperative day 1, 4 and 30 Recovery quality and time parameters using objective ICU score criteria Cardioprotection effect evaluated by myocardial biochemical markers obtained preoperative and postoperative 4, 9 and 18 hours

Official Title
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Fast-track in Cardiac Surgery. Remifentanyl & Sufentanil Anaesthesia for CABG+/-AVR Evaluated by Recovery, Cognitive Dysfunction, Haemodynamics (PAC/TTE) and Cardiac Biochemical Markers (CKMB, TNT, Pro-BNP)

Conditions
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Ischaemic Heart Disease, Aortic Stenosis

Intervention / Treatment
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* Drug: Remifentanil
* Drug: Sufentanil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for coronary artery bypass grafting (CABG) +/- aortic valve replacement (AVR) Exclusion Criteria: Ejection Fraction < 30% Previous Myocardial Infarction within 4 weeks Severe pulmonary hypertension (mean pulmonary artery pressure (mPAP) > 33% of mean arterial pressure (MAP) Arterial hypertension (Sap > 180, Dap > 110) Diabetes, Non- and Insulin dependent Non usable echocardiography windows

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 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: Remifentanil<br>Remifentanil the basic opioid drug in anesthesia | Drug: Remifentanil<br>* Randomization to receive Remifentanil (ultrashort acting opioid) as basic opioid in anaesthesia<br>* Other names: Ultiva;|
| Active Comparator: Sufentanil<br>Sufentanil the basic opioid drug in anesthesia | Drug: Sufentanil<br>* Randomization to receive Sufentanil (medium/long acting opioid) as basic opioid in anaesthesia<br>* Other names: Sufenta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive function score | Cognitive function evaluated by Palo Alto Veterans Hospital Test on all patients | Postoperative day 4 | 
| Fast-track potential | Ventilation time and eligible time to discharge based on ICU score | Time ((mean hours) to eligible discharge from ICU (up to 48 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eligible time to discharge from ICU | Estimation on hours in ICU before the patients were eligible for discharge from ICU = ICD4 (Total score < 5, and no single score > 2) using an objective ICU score. The ICU score is done each hour after extubation | Time (hours) to ICD4 | 
| Postoperative cognitive dysfunction | Changes from pre-operative cognitive function to postoperative cognitive function on day 1, 4 and 30 using cognitive function test from Palo Alto Veterans Hospital Test on all patients | Postoperative day 1 and 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal function, ICU discharge, Cognitive dysfunction, Cardioprotection, Recovery