Ischaemic Heart DiseasePhase 4PRECON2NCT02053818
Remifentanil/Sufentanil for CABG+/-AVR Evaluated by Recovery, Cognitive Function, Haemodynamics and Biochemical Markers.
A Phase 4 study testing Remifentanil and Sufentanil in people with Ischaemic Heart Disease and Aortic Stenosis, run by Aarhus University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Ischaemic Heart Disease, Aortic Stenosis
- What is being tested?
- Remifentanil and Sufentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2011to Aug 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for coronary artery bypass grafting (CABG) +/- aortic valve replacement (AVR)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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
- Conditions
- Ischaemic Heart Disease, Aortic Stenosis
- Being tested
- Remifentanil, Sufentanil
- Keywords
- Cognitive dysfunction, Cardioprotection, Recovery, Renal function, ICU discharge
- Medical subject headings
- Coronary Artery Disease, Aortic Valve Stenosis, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
Also called Ultiva
Randomization to receive Remifentanil (ultrashort acting opioid) as basic opioid in anaesthesia
SufentanilDrug
Also called Sufenta
Randomization to receive Sufentanil (medium/long acting opioid) as basic opioid in anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| Remifentanil | Active comparator | Remifentanil the basic opioid drug in anesthesia Receives: Drug: Remifentanil |
| Sufentanil | Active comparator | Sufentanil the basic opioid drug in anesthesia Receives: Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function score
Cognitive function evaluated by Palo Alto Veterans Hospital Test on all patients
Measured: Postoperative day 4
Fast-track potential
Ventilation time and eligible time to discharge based on ICU score
Measured: Time ((mean hours) to eligible discharge from ICU (up to 48 hours)
Secondary outcomes (2)
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
Measured: Time (hours) to ICD4
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
Measured: Postoperative day 1 and 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startAug 2011
- Primary completionJun 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischaemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carl-Johan Jakobsen, Aarhus University Hospital
- Investigators
- Carl-Johan Jakobsen, MD, Study director, Department of Anaesthesiology and Intensive Care, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02053818
- Sponsor's protocol ID
- 2010-022428-58
- Acronym
- PRECON2
- Status last verified
- Aug 2015
- First submitted
- 6 Jan 2014
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02053818
- Acronym / sponsor ID
- PRECON2 / 2010-022428-58
- Conditions
- Ischaemic Heart Disease, Aortic Stenosis
- Keywords
- Cognitive dysfunction, Cardioprotection, Recovery, Renal function, ICU discharge
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 4 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remifentanil | Active comparator | Drug: RemifentanilRemifentanil the basic opioid drug in anesthesia |
| Sufentanil | Active comparator | Drug: SufentanilSufentanil the basic opioid drug in anesthesia |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for coronary artery bypass grafting (CABG) +/- aortic valve replacement (AVR)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemifentanilAlso: UltivaRandomization to receive Remifentanil (ultrashort acting opioid) as basic opioid in anaesthesia | Drug | Remifentanil |
| SufentanilAlso: SufentaRandomization to receive Sufentanil (medium/long acting opioid) as basic opioid in anaesthesia | Drug | Sufentanil |
Primary outcome
Cognitive function score
Time frame: Postoperative day 4
Cognitive function evaluated by Palo Alto Veterans Hospital Test on all patients
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
2 secondary outcomes
Eligible time to discharge from ICU
Time frame: Time (hours) to ICD4
Postoperative cognitive dysfunction
Time frame: Postoperative day 1 and 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl-Johan Jakobsen, MD study director
Department of Anaesthesiology and Intensive Care, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remifentanil and Sufentanil in people with Ischaemic Heart Disease and Aortic Stenosis, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function score (time frame: Postoperative day 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2015.