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

Condition(s) targeted: Ischaemic Heart Disease; Aortic Stenosis

Intervention: Remifentanil (Drug); Sufentanil (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Aarhus University Hospital

Official(s) and/or principal investigator(s):
Carl-Johan Jakobsen, MD, Study Director, Affiliation: Department of Anaesthesiology and Intensive Care, Aarhus University Hospital

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.

Official title: 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)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Primary outcome:

Cognitive function score

Fast-track potential

Secondary outcome:

Eligible time to discharge from ICU

Postoperative cognitive dysfunction

Detailed description: 1. 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). 2. Cognitive dysfunction evaluated by standard test preoperative and postoperative day 1, 4 and 30 3. Recovery quality and time parameters using objective ICU score criteria 4. Cardioprotection effect evaluated by myocardial biochemical markers obtained preoperative and postoperative 4, 9 and 18 hours

Minimum age: 60 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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

Aarhus University Hospital, Aarhus N 8200, Denmark

Starting date: August 2011
Last updated: August 11, 2015