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

Phase 4

Completed

• Conditions: Ischaemic Heart Disease; Aortic Stenosis
• Interventions: Drug: Sufentanil; Drug: Remifentanil

• Registration Number: NCT02053818
• Lead Sponsor: Aarhus University Hospital

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 Timeline

• Study Start: 2011-08
• Study First Submitted: 2014-01-06
• Study First Submitted QC: 2014-02-01
• Study First Posted: 2014-02-04
• Primary Completion: 2015-06
• Status Verified: 2015-08
• Study Completion: 2015-08
• Last Update Submitted: 2015-08-11
• Last Update Posted: 2015-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sufentanil	Sufentanil	Sufentanil the basic opioid drug in anesthesia
Remifentanil	Remifentanil	Remifentanil the basic opioid drug in anesthesia

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus N, Denmark