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

Primary Purpose

Ischaemic Heart Disease, Aortic Stenosis

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Remifentanil
Sufentanil
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ischaemic Heart Disease focused on measuring Cognitive dysfunction, Cardioprotection, Recovery, Renal function, ICU discharge

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Remifentanil

Sufentanil

Arm Description

Remifentanil the basic opioid drug in anesthesia

Sufentanil the basic opioid drug in anesthesia

Outcomes

Primary Outcome Measures

Cognitive function score
Cognitive function evaluated by Palo Alto Veterans Hospital Test on all patients
Fast-track potential
Ventilation time and eligible time to discharge based on ICU score

Secondary Outcome Measures

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
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

Full Information

First Posted
January 6, 2014
Last Updated
August 11, 2015
Sponsor
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02053818
Brief Title
Remifentanil/Sufentanil for CABG+/-AVR Evaluated by Recovery, Cognitive Function, Haemodynamics and Biochemical Markers.
Acronym
PRECON2
Official 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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischaemic Heart Disease, Aortic Stenosis
Keywords
Cognitive dysfunction, Cardioprotection, Recovery, Renal function, ICU discharge

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Remifentanil
Arm Type
Active Comparator
Arm Description
Remifentanil the basic opioid drug in anesthesia
Arm Title
Sufentanil
Arm Type
Active Comparator
Arm Description
Sufentanil the basic opioid drug in anesthesia
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Other Intervention Name(s)
Ultiva
Intervention Description
Randomization to receive Remifentanil (ultrashort acting opioid) as basic opioid in anaesthesia
Intervention Type
Drug
Intervention Name(s)
Sufentanil
Other Intervention Name(s)
Sufenta
Intervention Description
Randomization to receive Sufentanil (medium/long acting opioid) as basic opioid in anaesthesia
Primary Outcome Measure Information:
Title
Cognitive function score
Description
Cognitive function evaluated by Palo Alto Veterans Hospital Test on all patients
Time Frame
Postoperative day 4
Title
Fast-track potential
Description
Ventilation time and eligible time to discharge based on ICU score
Time Frame
Time ((mean hours) to eligible discharge from ICU (up to 48 hours)
Secondary Outcome Measure Information:
Title
Eligible time to discharge from ICU
Description
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 Frame
Time (hours) to ICD4
Title
Postoperative cognitive dysfunction
Description
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
Time Frame
Postoperative day 1 and 30
Other Pre-specified Outcome Measures:
Title
Haemodynamic effects of opioids
Description
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
Time Frame
From induction anaesthesia until cardiopulmonary bypass
Title
Cardioprotection
Description
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
Time Frame
0,4,9,15 and 40 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl-Johan Jakobsen, MD
Organizational Affiliation
Department of Anaesthesiology and Intensive Care, Aarhus University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark

12. IPD Sharing Statement

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

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