Other Functional Disturbances Following Cardiac SurgeryPhase 4NCT00541918
COGNITIVE - Cognitive Function After Sevoflurane or Propofol Anesthesia for Open-heart Operations
A Phase 4 study testing Diprivan (propofol, Astra Zeneca) and Sevorane (sevoflurane, Abbott) in people with Other Functional Disturbances Following Cardiac Surgery and Memory Disorders, run by Medical University of Gdansk at 2 sites in Poland.
Trial summary
The aim of the study is to prove whether general anesthesia with inhaled sevoflurane reduces the frequency of neurological and cognitive impairment after open-heart operations with use of cardiopulmonary by-pass (CPB) in comparison with intravenous anesthesia with propofol. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Other Functional Disturbances Following Cardiac Surgery, Memory Disorders
- What is being tested?
- Diprivan (propofol, Astra Zeneca) and Sevorane (sevoflurane, Abbott)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesPoland
- Study dates
- Jun 2007to Apr 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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults
- valve-repair open-heart surgery without coronary artery bypass grafting
Who cannot join
- active infective endocarditis
- previous cardiac surgery
- emergency operations
- chronic renal failure (serum creatinine > 2,0 mg/dL)
- left ventricle ejection fraction < 30%
- myocardial infarction within last 30 days
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Department of Cardiac Anesthesiology, Medical University of Gdańsk
Gdansk, 80-211
Medical Universty of Gdańsk, Department of Cardiac and Vascular Surgery
Gdansk, 80-211
About this study
Official title: COGNITIVE - Comparison of Cognitive Function After Sevoflurane or Propofol Anesthesia for Open-heart Operations
The aim of the study is to prove whether general anesthesia with inhaled sevoflurane reduces the frequency of neurological and cognitive impairment after open-heart operations with use of cardiopulmonary by-pass (CPB) in comparison with intravenous anesthesia with propofol.
Read the detailed description
Patients assigned to the "sevoflurane" group will be anesthetized with inhaled sevoflurane (induction and conduction of general anesthesia) and empirically administered fentanyl und pancuronium. During the CPB, sevoflurane will be delivered via the oxygenator of the CPB-machine.
Patients assigned to the "propofol" group will be anesthetized with continuous propofol infusion and empirically administered fentanyl and pancuronium.
The level of anesthesia will be monitored with BIS (bi-spectral index) - desirable level of 40 - 60.
Following preoperative data will be recorded: age, years of school education, NYHA-class, LVEF by TTE, comorbidities, glucosylated hemoglobin in patients with diabetes, non-invasive arterial blood pressure the day before the operation, smoked cigarettes, alcohol abuse.
Recorded data from operation: type of surgery, CBP duration, aortic clamp duration, duration of arterial hypotension (MAP < 60 mmHg) on CPB or SAP < 90 after CPB, the lowest perfusion gradient (MAP-CVP), the lowest pO2 in arterial blood and lowest blood oxygen saturation, lowest and average brain blood saturation (measured by INVOS), steroid dosis, aprotinin dosis, mannitol dosis on CPB, epiaortic echocardiography for aortic clamping, TEE before weaning from CPB with evaluation of deaeration of the left ventricle, highest serum glucose level, highest oesophageal temperature.
Data collected after operation: time to tracheal extubation, doses of catecholamines, consciousness disorders, CRP, S-100b protein, glucose level, core temperature, ICU stay, stay at the surgery department, hospital stay.
The patients will undergo a psychological examination four times: before the operation, before discharge from hospital (usually 4-6 days after the operation), 3 and 12 months after the operation. The psychological test for evaluating the cognitive modalities will include:
- verbal learning - the Rey's AVLT test
- direct verbal memory - number repeating attempt from the WAIS-R/PL test
- direct nonverbal memory - Memory Test of Geometric Figures by Benton
- operating memory test - TMT test
- the cognitive interference test - a modified Stroop test
- verbal fluence - according to the Boston Test of Aphasia
- concentration and work effectiveness - by the Number Symbol test by Wechsler.
- mood - Beck's depression scale
- NEECHAM Delirium Scale - during the first 24-36 hours after surgery
- the Gough's Adjective Test will be performed with in-house relatives of the patient for evaluation the eventual emotional and eventual personality changes
Neurological examination will be performed before and 6 days after surgery.
- Being tested
- Diprivan (propofol, Astra Zeneca), Sevorane (sevoflurane, Abbott)
- Keywords
- sevoflurane,, propofol,, heart surgery,, cardiopulmonary bypass,, memory disorders,
- Medical subject headings
- Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diprivan (propofol, Astra Zeneca)Drug
Also called propofol
Total intravenous anesthesia with propofol
Sevorane (sevoflurane, Abbott)Drug
Also called sevoflurane
inhaled anesthesia with sevoflurane
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | propofol Receives: Drug: Diprivan (propofol, Astra Zeneca) |
| 2 | Experimental | sevoflurane Receives: Drug: Sevorane (sevoflurane, Abbott) |
What is being measured
The primary outcome is the main question the study is designed to answer.
results of psychological examination
Measured: 6 days, 3 and 12 months after surgery
Secondary outcomes (1)
S-100B protein level in serum. NEECHAM delirium scale, stroke or other severe neurological impairment
Measured: S-100B - 18 hours after surgery; Consciousness and/or neurological impairment - within 6 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2007 (estimated)
- Study startJun 2007
- Primary completionApr 2015
- Study completionApr 2015
Why it stopped: study suspended due to staff indisposition
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Functional Disturbances Following Cardiac SurgeryStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maciej M. Kowalik, Medical University of Gdansk
- Investigators
- Romuald Lango, M.D., Ph.D., Study director, Medical University of Gdańsk, Department of Cardiac Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00541918
- Sponsor's protocol ID
- AMG-NKBEN/560/2006
- Status last verified
- Oct 2015
- First submitted
- 9 Oct 2007
- Last updated
- 28 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COGNITIVE - Comparison of Cognitive Function After Sevoflurane or Propofol Anesthesia for Open-heart Operations
- ClinicalTrials.gov ID
- NCT00541918
- Acronym / sponsor ID
- AMG-NKBEN/560/2006
- Keywords
- sevoflurane,, propofol,, heart surgery,, cardiopulmonary bypass,, memory disorders,
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study suspended due to staff indisposition
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 10 Oct 2007 (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.
The aim of the study is to prove whether general anesthesia with inhaled sevoflurane reduces the frequency of neurological and cognitive impairment after open-heart operations with use of cardiopulmonary by-pass (CPB) in comparison with intravenous anesthesia with propofol.
Detailed description
Patients assigned to the "sevoflurane" group will be anesthetized with inhaled sevoflurane (induction and conduction of general anesthesia) and empirically administered fentanyl und pancuronium. During the CPB, sevoflurane will be delivered via the oxygenator of the CPB-machine.
Patients assigned to the "propofol" group will be anesthetized with continuous propofol infusion and empirically administered fentanyl and pancuronium.
The level of anesthesia will be monitored with BIS (bi-spectral index) - desirable level of 40 - 60.
Following preoperative data will be recorded: age, years of school education, NYHA-class, LVEF by TTE, comorbidities, glucosylated hemoglobin in patients with diabetes, non-invasive arterial blood pressure the day before the operation, smoked cigarettes, alcohol abuse.
Recorded data from operation: type of surgery, CBP duration, aortic clamp duration, duration of arterial hypotension (MAP < 60 mmHg) on CPB or SAP < 90 after CPB, the lowest perfusion gradient (MAP-CVP), the lowest pO2 in arterial blood and lowest blood oxygen saturation, lowest and average brain blood saturation (measured by INVOS), steroid dosis, aprotinin dosis, mannitol dosis on CPB, epiaortic echocardiography for aortic clamping, TEE before weaning from CPB with evaluation of deaeration of the left ventricle, highest serum glucose level, highest oesophageal temperature.
Data collected after operation: time to tracheal extubation, doses of catecholamines, consciousness disorders, CRP, S-100b protein, glucose level, core temperature, ICU stay, stay at the surgery department, hospital stay.
The patients will undergo a psychological examination four times: before the operation, before discharge from hospital (usually 4-6 days after the operation), 3 and 12 months after the operation. The psychological test for evaluating the cognitive modalities will include:
- verbal learning - the Rey's AVLT test
- direct verbal memory - number repeating attempt from the WAIS-R/PL test
- direct nonverbal memory - Memory Test of Geometric Figures by Benton
- operating memory test - TMT test
- the cognitive interference test - a modified Stroop test
- verbal fluence - according to the Boston Test of Aphasia
- concentration and work effectiveness - by the Number Symbol test by Wechsler.
- mood - Beck's depression scale
- NEECHAM Delirium Scale - during the first 24-36 hours after surgery
- the Gough's Adjective Test will be performed with in-house relatives of the patient for evaluation the eventual emotional and eventual personality changes
Neurological examination will be performed before and 6 days after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Diprivan (propofol, Astra Zeneca)propofol |
| 2 | Experimental | Drug: Sevorane (sevoflurane, Abbott)sevoflurane |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adults
- valve-repair open-heart surgery without coronary artery bypass grafting
Key exclusion criteria (6 listed)
- active infective endocarditis
- previous cardiac surgery
- emergency operations
- chronic renal failure (serum creatinine > 2,0 mg/dL)
- left ventricle ejection fraction < 30%
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 |
|---|---|---|
| Diprivan (propofol, Astra Zeneca)Also: propofolTotal intravenous anesthesia with propofol | Drug | 1 |
| Sevorane (sevoflurane, Abbott)Also: sevofluraneinhaled anesthesia with sevoflurane | Drug | 2 |
Primary outcome
results of psychological examination
Time frame: 6 days, 3 and 12 months after surgery
1 secondary outcome
S-100B protein level in serum. NEECHAM delirium scale, stroke or other severe neurological impairment
Time frame: S-100B - 18 hours after surgery; Consciousness and/or neurological impairment - within 6 days after surgery.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2015.
- Home page of the Department of Cardiac Anesthesiology, MUG.Link provided by the sponsor.
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.
Romuald Lango, M.D., Ph.D. study director
Medical University of Gdańsk, Department of Cardiac Anesthesiology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diprivan (propofol, Astra Zeneca) and Sevorane (sevoflurane, Abbott) in people with Other Functional Disturbances Following Cardiac Surgery and Memory Disorders, run by Medical University of Gdansk at 2 sites in Poland.
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 2 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: withdrawn, as of the sponsor's last update on 28 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. 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 was withdrawn before enrolling participants, so there are no results.
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?
results of psychological examination (time frame: 6 days, 3 and 12 months after surgery). 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 28 Oct 2015.