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

Phase 4CompletedNCT02053818

Aarhus University Hospital60 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Ischaemic Heart Disease Aortic Stenosis

Interventions

RemifentanilDRUG

Randomization to receive Remifentanil (ultrashort acting opioid) as basic opioid in anaesthesia

SufentanilDRUG

Randomization to receive Sufentanil (medium/long acting opioid) as basic opioid in anaesthesia

Eligibility

Sex: ALLMin age: 60 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Aarhus University Hospital

Aarhus N, Denmark

Outcomes

Primary Outcomes

Cognitive function score

Cognitive function evaluated by Palo Alto Veterans Hospital Test on all patients

Time frame: Postoperative day 4

Fast-track potential

Ventilation time and eligible time to discharge based on ICU score

Time frame: Time ((mean hours) to eligible discharge from ICU (up to 48 hours)

Secondary Outcomes

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 frame: 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

Time frame: Postoperative day 1 and 30

Data from ClinicalTrials.gov

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