Contact information
Type
Scientific
Primary contact
Prof Matthias Heringlake
ORCID ID
Contact details
Department of Anesthesiology
University of Luebeck
Ratzeburger Allee 160
Luebeck
23538
Germany
heringlake@t-online.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Cogdys1
Study information
Scientific title
Cognitive function after sevoflurane- versus propofol-based anaesthesia for on-pump cardiac surgery: a randomised controlled trial
Acronym
C01
Study hypothesis
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
The Ethical Committee of the University of Luebeck approved in February 2006 (ref: 05-139)
Study design
Randomised controlled investigator-blinded trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Sevoflurane, etomidate, sufentanil, pancuronium, remifentanil, propofol
Primary outcome measures
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 trial start date
01/09/2006
Overall trial end date
30/09/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
n = 64 for each group, total N = 128
Participant 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
Recruitment start date
01/09/2006
Recruitment end date
30/09/2008
Locations
Countries of recruitment
Germany
Trial participating centre
Department of Anesthesiology
Luebeck
23538
Germany
Sponsor information
Organisation
University of Luebeck (Germany)
Sponsor details
Ratzeburger Allee 160
Luebeck
D-23538
Germany
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Luebeck (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary