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

Sponsor

Aarhus University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02053818

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ischaemic Heart Disease Aortic Stenosis	Drug: Remifentanil Drug: Sufentanil	Phase 4

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

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 Start Date :

Aug 1, 2011

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Aug 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Eligible time to discharge from ICU [Time (hours) to ICD4]
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
Postoperative cognitive dysfunction [Postoperative day 1 and 30]
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

Other Outcome Measures

Haemodynamic effects of opioids [From induction anaesthesia until cardiopulmonary bypass]
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
Cardioprotection [0,4,9,15 and 40 hours after surgery]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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