General anaesthetic versus local anaesthetic for carotid surgery "GALA"

Completed

Phase N/A Results

Trial Description

To compare the risk of stroke, myocardial infarction and death as a result of carotid endarterectomy under either general or local anaesthesia.

Interventions

  • Endarterectomy, carotid (CEA)Procedure/Surgery
    Intervention Desc: Surgical therapy to remove atherosclerotic plaque in narrowed carotid arteries.

Trial Design

Multi-center, randomised trial.

Patient Involvement

Eligible patients were randomized to receive carotid endarterectomy under either local or general anaesthesia. Hospital follow-up at discharge, 7 days post-surgery or death. Neurology follow-up at one month post-surgery. One year follow-up. Quality of life assessments performed at 30 days post-surgery (UK only).

Outcomes

Type Measure Time Frame Safety Issue
Primary Relative and absolute differences in the proportion of patients alive and stroke-free (including retinal infarction) and without myocardial infarction at 30 days after surgery, or 30 days after randomisation for those few patients when surgery was scheduled but never carried out.
Secondary Proportion of patients 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.

Sponsors

The Health Foundation, European Society for Vascular Surgery