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 |
| Protocol serial number | N0054119938 |
| Sponsor | Department of Health (UK) |
| Funder | The Cardiothoracic Centre Liverpool NHS Trust (UK) |
- 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
Scientific
Department of Anaesthesia
The Cardiothoracic Centre
Liverpool NHS Trust
Thomas Drive
Liverpool
L14 3PE
United Kingdom
| Phone | +44 (0)151 228 1616 |
|---|---|
| abc@email.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomised double-blind study |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Thiopentone and ketamine versus isoflurane and fentanyl |
| Primary outcome measure(s) |
Assessment of neurological outcome, mood, personality and quality of life and correlations with any change in neuropsychological function will be made. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/03/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| 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
- United Kingdom
- England
Study participating centre
Liverpool NHS Trust
Liverpool
L14 3PE
United Kingdom
L14 3PE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
