Brief Title
Remifentanil/Sufentanil for CABG+/-AVR Evaluated by Recovery, Cognitive Function, Haemodynamics and Biochemical Markers.
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)
Brief Summary
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
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
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Cognitive function score
Secondary Outcome
Eligible time to discharge from ICU
Condition
Ischaemic Heart Disease
Intervention
Remifentanil
Study Arms / Comparison Groups
Remifentanil
Description: Remifentanil the basic opioid drug in anesthesia
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
60
Start Date
August 2011
Completion Date
August 2015
Primary Completion Date
June 2015
Eligibility 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
Gender
All
Ages
60 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Carl-Johan Jakobsen, MD, ,
Location Countries
Denmark
Location Countries
Denmark
Administrative Informations
NCT ID
NCT02053818
Organization ID
2010-022428-58
Responsible Party
Principal Investigator
Study Sponsor
Aarhus University Hospital
Study Sponsor
Carl-Johan Jakobsen, MD, Study Director, Department of Anaesthesiology and Intensive Care, Aarhus University Hospital
Verification Date
August 2015