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

Completed

• Conditions: Carotid stenosis (at risk from stroke); Surgery; Carotid stenosis

• Registration Number: ISRCTN00525237
• Lead Sponsor: The Health Foundation (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2002-09-12
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 3526

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of patients alive, stroke free (including retinal infarction) and without myocardial infarction (MI) 30 days post-surgery.

Secondary Outcome Measures

Name	Time	Method
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.