Condition category
Surgery
Date applied
18/02/2010
Date assigned
15/03/2010
Last edited
15/03/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.mu-luebeck.de/

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

Publication citations

Additional files

Editorial Notes