Aortic Stenosis, Ischaemic Heart Disease
Conditions
Keywords
Cognitive dysfunction, Cardioprotection, Recovery, Renal function, ICU discharge
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
Interventions
DRUGRemifentanil
Randomization to receive Remifentanil (ultrashort acting opioid) as basic opioid in anaesthesia
DRUGSufentanil
Randomization to receive Sufentanil (medium/long acting opioid) as basic opioid in anaesthesia
Sponsors
Aarhus University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Denmark
Outcome results
None listed