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Remifentanil/Sufentanil for CABG+/-AVR Evaluated by Recovery, Cognitive Function, Haemodynamics and Biochemical Markers. (PRECON2)

A

Aarhus University Hospital

Status and phase

Completed
Phase 4

Conditions

Aortic Stenosis
Ischaemic Heart Disease

Treatments

Drug: Sufentanil
Drug: Remifentanil

Study type

Interventional

Funder types

Other

Identifiers

NCT02053818
2010-022428-58

Details and patient eligibility

About

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.

Full 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

Enrollment

60 patients

Sex

All

Ages

60 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Remifentanil
Active Comparator group
Description:
Remifentanil the basic opioid drug in anesthesia
Treatment:
Drug: Remifentanil
Sufentanil
Active Comparator group
Description:
Sufentanil the basic opioid drug in anesthesia
Treatment:
Drug: Sufentanil

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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