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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Ischaemic Heart Disease Aortic Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Remifentanil

Remifentanil the basic opioid drug in anesthesia

Group Type ACTIVE_COMPARATOR

Remifentanil

Intervention Type DRUG

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

Sufentanil

Sufentanil the basic opioid drug in anesthesia

Group Type ACTIVE_COMPARATOR

Sufentanil

Intervention Type DRUG

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

Interventions

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Remifentanil

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

Intervention Type DRUG

Sufentanil

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

Intervention Type DRUG

Other Intervention Names

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Ultiva Sufenta

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No