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ISRCTN
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ISRCTN44821042
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ClinicalTrials.gov identifier
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Public title
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Cognitive function after sevoflurane- versus propofol-based anaesthesia for on-pump cardiac surgery
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Scientific title
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Cognitive function after sevoflurane- versus propofol-based anaesthesia for on-pump cardiac surgery: a randomised controlled trial
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Acronym
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C01
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Serial number at source
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Cogdys1
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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The Ethical Committee of the University of Luebeck approved in February 2006 (ref: 05-139)
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Study design
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Randomised controlled investigator-blinded trial
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Cardiac surgery, cognitive dysfunction
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/09/2006
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Anticipated end date
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30/09/2008
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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n = 64 for each group, total N = 128
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Interventions
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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.
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Primary outcome measure(s)
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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
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Secondary outcome measure(s)
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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
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Sources of funding
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University of Luebeck (Germany)
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Trial website
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Publications
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Contact name
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Prof
Matthias
Heringlake
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Address
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Department of Anesthesiology
University of Luebeck
Ratzeburger Allee 160
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City/town
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Luebeck
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Zip/Postcode
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23538
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Country
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Germany
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Email
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heringlake@t-online.de
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Sponsor
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University of Luebeck (Germany)
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Address
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Ratzeburger Allee 160
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City/town
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Luebeck
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Zip/Postcode
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D-23538
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Country
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Germany
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Sponsor website:
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http://www.mu-luebeck.de/
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Date applied
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18/02/2010
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Last edited
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15/03/2010
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Date ISRCTN assigned
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15/03/2010
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