An international multicentre randomised trial comparing general anaesthetic versus local anaesthetic for carotid surgery

ISRCTN	ISRCTN00525237
DOI	https://doi.org/10.1186/ISRCTN00525237
Secondary identifying numbers	2268/1979

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

Study website

Contact information

Ms Bridget Colam
Scientific

Neurosciences Trials Unit
Bramwell Dott Building
Western General Hospital
Crewe Road
Edinburgh
EH4 2XU
United Kingdom

Phone	+44 (0)131 537 2930
Email	gala@skull.dcn.ed.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
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	The proportion of patients alive, stroke free (including retinal infarction) and without myocardial infarction (MI) 30 days post-surgery.
Secondary outcome measures	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.
Overall study start date	01/06/1999
Completion date	30/04/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	5,000 (as of 19/05/08, the total recruited: 3,526)
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

Australia
Austria
Belarus
China
Croatia
Czech Republic
Estonia
Georgia
Germany
Greece
Hungary
Israel
Italy
Latvia
Netherlands
Poland
Portugal
Saudi Arabia
Scotland
Slovakia
Spain
Sweden
Türkiye
Ukraine
United Kingdom

Study participating centre

Neurosciences Trials Unit

Edinburgh
EH4 2XU
United Kingdom

Sponsor information

The Health Foundation (UK)
Charity

90 Long Acre
London
WC2E 9RA
United Kingdom

Phone	+44 (0)20 7257 8000
Email	info@health.org.uk
Website	http://www.pppfoundation.org.uk/
"ROR"	https://ror.org/02bzj4420

Funders

Funder type

Charity

The Health Foundation (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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	Protocol	21/05/2008		Yes	No
Results article	results	20/12/2008		Yes	No