Carotid stenosis (at risk from stroke) Surgery Carotid stenosis
Conditions
Interventions
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 de
Sponsors
The Health Foundation (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients alive, stroke free (including retinal infarction) and without myocardial infarction (MI) 30 days post-surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Australia, Austria, Belarus, China, Croatia, Czech Republic, Estonia, Georgia, Germany, Greece, Hungary, Israel, Italy, Latvia, Netherlands, Poland, Portugal, Saudi Arabia, Slovakia, Spain, Sweden, Turkey, Ukraine, United Kingdom
Outcome results
None listed