An international multicentre randomised trial comparing general anaesthetic versus local anaesthetic for carotid surgery
| ISRCTN | ISRCTN00525237 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN00525237 |
| Protocol serial number | 2268/1979 |
| Sponsor | The Health Foundation (UK) |
| Funder | The Health Foundation (UK) |
- Submission date
- 12/09/2002
- Registration date
- 12/09/2002
- Last edited
- 31/12/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Bridget Colam
Scientific
Scientific
Neurosciences Trials Unit
Bramwell Dott Building
Western General Hospital
Crewe Road
Edinburgh
EH4 2XU
United Kingdom
| Phone | +44 (0)131 537 2930 |
|---|---|
| gala@skull.dcn.ed.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | GALA |
| Study objectives | A prospective, randomised trial of local versus general anaesthesia for carotid endarterectomy is proposed to determine whether the type of anaesthesia does indeed influence peri-operative morbidity and mortality, quality of life and long term outcome in terms of stroke-free survival. Please note that as of 29/05/2008 this record was updated to include a longer recruitment period. All changes can be found under the relevant fields, with the update date of 29/05/2008. The anticipated end date of this trial was extended to 30/04/2008. The previous anticipated end date of this trial was 31/12/2006. Randomisation stopped on 31/10/2007 and the presentation of results is expected on 06/09/08. |
| Ethics approval(s) | Ethics approval received from the Northern and Yorkshire MREC on the 28th August 1998 (pilot phase) and 22nd April 2003 (main phase). |
| Health condition(s) or problem(s) studied | Carotid stenosis (at risk from stroke) |
| Intervention | Anaesthetic for surgery - local versus general. Randomisation will be by telephone to the trial office. Data will be collected at baseline (prior to randomisation) and this will include demographic details, known risk factors, diagnostic procedures and findings, and indications for surgery. The follow-up data will be collected when the patient is discharged from acute care, and operative details and any early complications will be recorded. At 1 month post-surgery, a stroke physician, blind to the type of anaesthesia, will review the patient. Also the patient will be asked to complete a health related quality of life questionnaire including the widely used EuroQol and Short Form 36, plus a carotid endarterectomy (CEA) specific questionnaire designed to capture patient satisfaction levels with the method of anaesthesia. Length of time spent in the recovery room, intensive care unit (ICU) and high dependency unit (HDU), and length of overall acute hospital stay will be recorded. Annual follow up will be by post to the family doctor and to the patient, seeking details of any strokes. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
The proportion of patients alive, stroke free (including retinal infarction) and without myocardial infarction (MI) 30 days post-surgery. |
| Key secondary outcome measure(s) |
Proportion alive and stroke free at one year and in the longer term, a comparison of health related quality of life at 30 days and any surgical adverse events, re-operation and re-admission rates, the relative cost of the two methods of anaesthesia, length of stay and intensive and high dependency bed occupancy. |
| Completion date | 30/04/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 3526 |
| Key inclusion criteria | The main criterion for entry into this study is that, in the opinion of the responsible clinician, the patient requiring an endarterectomy is suitable for either local or general anaesthesia, and there is no clear indication for either type. All patients with either symptomatic or asymptomatic internal carotid stenosis for whom surgery is advised are eligible. There is no upper age limit. |
| Key exclusion criteria | 1. Failure to obtain informed consent 2. Patient unable to co-operate with awake testing during local anaesthesia 3. Patient considered unfit for general anaesthesia 4. Patient considered unfit for local anaesthesia 5. Patient requiring simultaneous bilateral carotid endarterectomy 6. Carotid endarterectomy combined with another operative artery bypass surgery 7. Patient has been randomised into the trial previously |
| Date of first enrolment | 01/06/1999 |
| Date of final enrolment | 30/04/2008 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
- Australia
- Austria
- Belarus
- China
- Croatia
- Czech Republic
- Estonia
- Georgia
- Germany
- Greece
- Hungary
- Israel
- Italy
- Latvia
- Netherlands
- Poland
- Portugal
- Saudi Arabia
- Slovakia
- Spain
- Sweden
- Türkiye
- Ukraine
Study participating centre
Neurosciences Trials Unit
Edinburgh
EH4 2XU
United Kingdom
EH4 2XU
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 20/12/2008 | Yes | No | |
| Protocol article | Protocol | 21/05/2008 | Yes | No | |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
