Contact information
Type
Scientific
Primary contact
Dr J Murphy
ORCID ID
Contact details
Department of Anaesthesia
The Cardiothoracic Centre
Liverpool NHS Trust
Thomas Drive
Liverpool
L14 3PE
United Kingdom
+44 (0)151 228 1616
abc@email.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0054119938
Study information
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)
Acronym
Study hypothesis
To compare neurophysiological function after maintaining anaesthesia for cardiopulmonary bypass (CPB) with either:
1.Thiopentone and ketamine, or
2. Isoflurane and fentanyl
Ethics approval
Not provided at time of registration
Study design
Prospective randomised double-blind study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Thiopentone and ketamine versus isoflurane and fentanyl
Primary outcome measures
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 trial start date
18/10/2002
Overall trial end date
01/03/2004
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
18/10/2002
Recruitment end date
01/03/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Liverpool NHS Trust
Liverpool
L14 3PE
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
The Cardiothoracic Centre Liverpool NHS Trust (UK)
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