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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02053818
Other study ID # 2010-022428-58
Secondary ID
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


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
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