Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
05/12/2014
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

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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes