Remifentanil/Sufentanil for CABG+/-AVR Evaluated by Recovery, Cognitive Function, Haemodynamics and Biochemical Markers. (PRECON2)

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)

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.

Study Overview

• Status: Completed
• Conditions: Aortic Stenosis; Ischaemic Heart Disease
• Intervention / Treatment: Drug: Remifentanil; Drug: Sufentanil

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Aarhus N, Denmark, 8200
    • Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Remifentanil; Remifentanil the basic opioid drug in anesthesia	Drug: Remifentanil; Randomization to receive Remifentanil (ultrashort acting opioid) as basic opioid in anaesthesia; Other Names: Ultiva
Active Comparator: Sufentanil; Sufentanil the basic opioid drug in anesthesia	Drug: Sufentanil; Randomization to receive Sufentanil (medium/long acting opioid) as basic opioid in anaesthesia; Other Names: Sufenta

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Haemodynamic effects of opioids	Evaluation of haemodynamic indexes (cardiac index, stroke volume index, central venous oxygenation, blood pressure, Heart rate) together with echocardiographic evaluation of systolic and diastolic function. Evaluation both by single opioid and combination with propofol	From induction anaesthesia until cardiopulmonary bypass
Cardioprotection	Evaluation based on myocardial biochemical markers CK-MB, Troponin-T and Nt-Pro-BNP preoperative and 4, 9 and 15 and 40 hours after surgery	0,4,9,15 and 40 hours after surgery

Collaborators and Investigators

• Sponsor: Aarhus University Hospital
• Investigators: Study Director: Carl-Johan Jakobsen, MD, Department of Anaesthesiology and Intensive Care, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: January 6, 2014
• First Submitted That Met QC Criteria: February 1, 2014
• First Posted (Estimate): February 4, 2014

Study Record Updates

• Last Update Posted (Estimate): August 13, 2015
• Last Update Submitted That Met QC Criteria: August 11, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Recovery; Cardioprotection; Renal function; Cognitive dysfunction; ICU discharge
• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Neurocognitive Disorders; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Coronary Disease; Cognition Disorders; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Aortic Valve Stenosis; Cognitive Dysfunction; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Remifentanil; Sufentanil
• Other Study ID Numbers: 2010-022428-58