Thiopentone and ketamine versus isoflurane and fentanyl to maintain anaesthesia during cardiopulmonary bypass; effect on postoperative neuropsychological function. Neuropsychological Function after Coronary Artery Bypass Graft (CABG)

ISRCTN	ISRCTN89332886
DOI	https://doi.org/10.1186/ISRCTN89332886
Secondary identifying numbers	N0054119938

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 05/12/2014

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

Dr J Murphy
Scientific

Department of Anaesthesia
The Cardiothoracic Centre
Liverpool NHS Trust
Thomas Drive
Liverpool
L14 3PE
United Kingdom

Phone	+44 (0)151 228 1616
Email	abc@email.com

Study information

Study design	Prospective randomised double-blind study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Thiopentone and ketamine versus isoflurane and fentanyl to maintain anaesthesia during cardiopulmonary bypass; effect on postoperative neuropsychological function. Neuropsychological Function after Coronary Artery Bypass Graft (CABG)
Study objectives	To compare neurophysiological function after maintaining anaesthesia for cardiopulmonary bypass (CPB) with either: 1.Thiopentone and ketamine, or 2. Isoflurane and fentanyl
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Surgery: Anaesthesia
Intervention	Only the anaesthetist will be aware of which treatment is being given but they will not be involved in gathering the primary outcome data. Patients will undergo standard neuropsychological assessments and neurological examinations before and after surgery. Thiopentone and ketamine preserve neuropsychological function after CABG when compared to standard technique.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Thiopentone and ketamine versus isoflurane and fentanyl
Primary outcome measure	Assessment of neurological outcome, mood, personality and quality of life and correlations with any change in neuropsychological function will be made.
Secondary outcome measures	Not provided at time of registration
Overall study start date	18/10/2002
Completion date	01/03/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Not provided at time of registration
Key inclusion criteria	1. All patients scheduled for elective CABG under the care of two surgical/anaesthetic teams 2. Under 80 years of age 3. Do not have porphyria, severe unstable coronary artery disease (UCAD) or who have hypersensitivity to any of the study drugs or central nervous system (CNS) disease.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	18/10/2002
Date of final enrolment	01/03/2004

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Liverpool NHS Trust

Liverpool
L14 3PE
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

The Cardiothoracic Centre Liverpool NHS Trust (UK)

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