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Completed

NCT Number: NCT02053818

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

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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Key information

Conditions

Ischaemic Heart Disease Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Cognition Disorders Cognitive Dysfunction Coronary Artery Disease Coronary Disease Heart Diseases Heart Valve Diseases Mental Disorders Myocardial Ischemia Neurocognitive Disorders Vascular Diseases Ventricular Outflow Obstruction

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aarhus University Hospital

Aarhus N, 8200, Denmark

About this study

  • 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).
  • Cognitive dysfunction evaluated by standard test preoperative and postoperative day 1, 4 and 30
  • Recovery quality and time parameters using objective ICU score criteria
  • Cardioprotection effect evaluated by myocardial biochemical markers obtained preoperative and postoperative 4, 9 and 18 hours

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remifentanil

Drug

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

Other names: Ultiva

Sufentanil

Drug

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

Other names: Sufenta

Primary outcomes

  1. Cognitive function score

    Time frame: Postoperative day 4

    Cognitive function evaluated by Palo Alto Veterans Hospital Test on all patients

  2. Fast-track potential

    Time frame: Time ((mean hours) to eligible discharge from ICU (up to 48 hours)

    Ventilation time and eligible time to discharge based on ICU score

Secondary outcomes

  1. Eligible time to discharge from ICU

    Time frame: 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

  2. Postoperative cognitive dysfunction

    Time frame: 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

Other outcomes

  1. Haemodynamic effects of opioids

    Time frame: 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

  2. Cardioprotection

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Registry information

Official study 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)

Acronym: PRECON2

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Feb 4, 2014
Registry last updated
Aug 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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