Cognitive function after sevoflurane- versus propofol-based anaesthesia for on-pump cardiac surgery
| ISRCTN | ISRCTN44821042 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44821042 |
| Secondary identifying numbers | Cogdys1 |
- Submission date
- 18/02/2010
- Registration date
- 15/03/2010
- Last edited
- 15/03/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Matthias Heringlake
Scientific
Scientific
Department of Anesthesiology
University of Luebeck
Ratzeburger Allee 160
Luebeck
23538
Germany
| heringlake@t-online.de |
Study information
| Study design | Randomised controlled investigator-blinded trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Cognitive function after sevoflurane- versus propofol-based anaesthesia for on-pump cardiac surgery: a randomised controlled trial |
| Study acronym | C01 |
| Study objectives | The present study was designed to contribute to the question, whether a sevoflurane-based anesthesia concept improves cognitive outcomes in patients undergoing cardiac surgery with cardiopulmonary bypass in comparison to a propofol-based total intravenous anaesthesia. The secondary objective was to determine if the treatment with sevoflurane in comparison to a propofol-based anaesthesia leads to differences in regional cerebral oxygenation measured with near-infrared spectroscopy (NIRS). Further, differences in the relationship between regional cerebral desaturation and cognitive decline, and differences between anaesthetic regimens regarding relevant clinical outcome-parameters should be investigated. |
| Ethics approval(s) | The Ethical Committee of the University of Luebeck approved in February 2006 (ref: 05-139) |
| Health condition(s) or problem(s) studied | Cardiac surgery, cognitive dysfunction |
| Intervention | Anaesthesia protocol 1: intravenous group (PROP): Induction: etomidate 0.2 - 0.3 mg/kg, sufentanil 1 µg/kg, pancuronium 0.07 - 0.1 mg/kg Maintenance: remifentanil 0.2 - 0.25 µg/kg/min, propofol 3 - 5 mg/kg/h achieving a bispectral index (BIS) of 40 - 50. Anaesthesia protocol 2: volatile group (SEVO): Induction: etomidate 0.2 - 0.3 mg/kg, sufentanil 1 µg/kg, pancuronium 0.07 - 0.1 mg/kg Maintenance: sevoflurane 0.6 - 1.5 MAC, remifentanil 0.2 - 0.25 µg/kg/min achieving a BIS of 40 - 50 During cardiopulmonary bypass: remifentanil 0.2 - 0.25 µg/kg/min, propofol 3 - 5 mg/kg/h achieving a BIS of 40 - 50 The treatment was carried out throughout the surgical procedure. The follow up was conducted 2, 4 and 6 days after surgery. The total length of hospital stay was recorded post hoc. No follow up after hospital discharge was performed. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Sevoflurane, etomidate, sufentanil, pancuronium, remifentanil, propofol |
| Primary outcome measure | Cognitive function measured with the abbreviated mental-test (AMT), stroop-test, trail-making-test (TMT), word-lists (WL), and mood-assessment-tests on day 2, 4 and 6 after cardiac surgery |
| Secondary outcome measures | 1. Markers of myocardial, cerebral and renal damage (creatine kinase [CK]/creatine kinase myocardial bands [CK-MB], troponin, high sensitivity troponin [hsTroponin], N-terminal prohormone brain natriuretic peptide [NT-proBNP], neurone specific enolase [NSE], beta-subunit of S100 protein [S100beta], neutrophil gelatinase-associated lipocalin [NGAL], cystatin C [CysC], creatinine), measured 2, 4 and 6 days after surgery 2. Clinical outcome concerning brain, kidney and heart, recorded 6 days after surgery |
| Overall study start date | 01/09/2006 |
| Completion date | 30/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 85 Years |
| Sex | Both |
| Target number of participants | n = 64 for each group, total N = 128 |
| Key inclusion criteria | 1. Aged between 18 and 85 years, either sex 2. Elective or urgent cardiac surgery with cardiopulmonary bypass 3. American Society of Anaesthesiologists (ASA) grade I to IV |
| Key exclusion criteria | 1. Overt neurological diseases or dementia 2. Significant stenosis of the carotid arteries 3. Pregnancy 4. Disposition for malignant hyperthermia 5. Use of monoamine oxidase-inhibitors 6. Insufficient knowledge of the German language 7. Emergency indication |
| Date of first enrolment | 01/09/2006 |
| Date of final enrolment | 30/09/2008 |
Locations
Countries of recruitment
- Germany
Study participating centre
Department of Anesthesiology
Luebeck
23538
Germany
23538
Germany
Sponsor information
University of Luebeck (Germany)
University/education
University/education
Ratzeburger Allee 160
Luebeck
D-23538
Germany
| Website | http://www.mu-luebeck.de/ |
|---|---|
"ROR" |
https://ror.org/00t3r8h32 |
Funders
Funder type
University/education
University of Luebeck (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
