NCT02053818

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2014

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 4, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

August 13, 2015

Status Verified

August 1, 2015

Enrollment Period

3.8 years

First QC Date

January 6, 2014

Last Update Submit

August 11, 2015

Conditions

Ischaemic Heart DiseaseAortic Stenosis

Keywords

Cognitive dysfunctionCardioprotectionRecoveryRenal functionICU discharge

Outcome Measures

Primary Outcomes (2)

  • Cognitive function score

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

    Postoperative day 4

  • 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)

Secondary Outcomes (2)

  • Eligible time to discharge from ICU

    Time (hours) to ICD4

  • Postoperative cognitive dysfunction

    Postoperative day 1 and 30

Other Outcomes (2)

  • Haemodynamic effects of opioids

    From induction anaesthesia until cardiopulmonary bypass

  • Cardioprotection

    0,4,9,15 and 40 hours after surgery

Study Arms (2)

Remifentanil

ACTIVE COMPARATOR

Remifentanil the basic opioid drug in anesthesia

Drug: Remifentanil

Sufentanil

ACTIVE COMPARATOR

Sufentanil the basic opioid drug in anesthesia

Drug: Sufentanil

Interventions

RemifentanilDRUG

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

Also known as: Ultiva
Remifentanil
SufentanilDRUG

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

Also known as: Sufenta
Sufentanil

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for coronary artery bypass grafting (CABG) +/- aortic valve replacement (AVR)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Coronary Artery DiseaseAortic Valve StenosisCognitive Dysfunction

Interventions

RemifentanilSufentanil

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesAortic Valve DiseaseHeart Valve DiseasesVentricular Outflow ObstructionCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFentanyl

Study Officials

  • Carl-Johan Jakobsen, MD

    Department of Anaesthesiology and Intensive Care, Aarhus University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Consultant, Ass professor

Study Record Dates

First Submitted

January 6, 2014

First Posted

February 4, 2014

Study Start

August 1, 2011

Primary Completion

June 1, 2015

Study Completion

August 1, 2015

Last Updated

August 13, 2015

Record last verified: 2015-08

Locations

DK(1)