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

Aortic Stenosis Clinical Trial

— PRECON2  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02053818
• Other study ID #: 2010-022428-58
• Status: Completed
• Phase: Phase 4
• First received: January 6, 2014
• Last updated: August 11, 2015
• Start date: August 2011
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Coronary Artery Disease
• Ischaemic Heart Disease
• Myocardial Ischemia

Intervention

Drug:
• Remifentanil
Randomization to receive Remifentanil (ultrashort acting opioid) as basic opioid in anaesthesia
• Sufentanil
Randomization to receive Sufentanil (medium/long acting opioid) as basic opioid in anaesthesia

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus N

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Yes
Other	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	No
Primary	Cognitive function score	Cognitive function evaluated by Palo Alto Veterans Hospital Test on all patients	Postoperative day 4	No
Primary	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)	No
Secondary	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	No
Secondary	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	No