GALA: an international multicentre randomised trial comparing general anaesthesia versus local anaesthesia for carotid surgery

Michael J Gough¹ , Andrew Bodenham² , Michael Horrocks³ , Bridget Colam⁴ , Steff C Lewis⁴ , Peter M Rothwell⁵ , Adrian P Banning⁶ , David Torgerson⁷ , Moira Gough¹ , Demosthenes Dellagrammaticas¹ , Anne Leigh-Brown⁸ , Christos Liapis⁹ and Charles Warlow⁴

¹Vascular Surgical Unit, Leeds General Infirmary, Great George Street, Leeds LS1 3EX, UK

²Department of Anaesthesia, Leeds General Infirmary, Great George Street, Leeds LS1 3EX, UK

³University Department of Surgery, Royal United Hospital Trust, Combe Park, Bath, BA1 3NG, UK

⁴Neurosciences Trials Unit, Division of Clinical Neurosciences, Edinburgh University, Western General Hospital, Crewe Road, Edinburgh EH4 2XU, UK

⁵Department of Clinical Neurology, Radcliffe Infirmary, Woodstock Road, Oxford OX2 6HE, UK

⁶Department of Cardiology, Radcliffe Infirmary, Woodstock Road, Oxford OX2 6HE, UK

⁷Central for Health Economics, University of York, Heslington, York YO1 5DD, UK

⁸Data Intelligence Group, Information Services Division, NHS National Services Scotland, Gyle Square, Edinburgh EH12 9ED, UK

⁹Department of Vascular Surgery, Athens University Medical School, Laiko General Hospital, 16 Sevastoupoleos Street, 115 26 Athens, Greece

author email corresponding author email

Trials 2008, 9:28doi:10.1186/1745-6215-9-28


Published:	21 May 2008

Abstract

Background

Patients who have severe narrowing at or near the origin of the internal carotid artery as a result of atherosclerosis have a high risk of ischaemic stroke ipsilateral to the arterial lesion. Previous trials have shown that carotid endarterectomy improves long-term outcomes, particularly when performed soon after a prior transient ischaemic attack or mild ischaemic stroke. However, complications may occur during or soon after surgery, the most serious of which is stroke, which can be fatal. It has been suggested that performing the operation under local anaesthesia, rather than general anaesthesia, may be safer. Therefore, a prospective, randomised trial of local versus general anaesthesia for carotid endarterectomy was proposed to determine whether type of anaesthesia influences peri-operative morbidity and mortality, quality of life and longer term outcome in terms of stroke-free survival.

Methods/design

A two-arm, parallel group, multicentre randomised controlled trial with a recruitment target of 5000 patients. For entry into the study, in the opinion of the responsible clinician, the patient requiring an endarterectomy must be suitable for either local or general anaesthesia, and have no clear indication for either type. All patients with symptomatic or asymptomatic internal carotid stenosis for whom open surgery is advised are eligible. There is no upper age limit. Exclusion criteria are: no informed consent; definite preference for local or general anaesthetic by the clinician or patient; patient unlikely to be able to co-operate with awake testing during local anaesthesia; patient requiring simultaneous bilateral carotid endarterectomy; carotid endarterectomy combined with another operation such as coronary bypass surgery; and, the patient has been randomised into the trial previously. Patients are randomised to local or general anaesthesia by the central trial office. The primary outcome is the proportion of patients alive, stroke free (including retinal infarction) and without myocardial infarction 30 days post-surgery. Secondary outcomes include the proportion of patients alive and stroke free at one year; health related quality of life at 30 days; 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.

Trial registration

Current Controlled Trials ISRCTN00525237