Περίληψη:
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.
Συγγραφείς:
Gough, Michael J.
Bodenham, Andrew
Horrocks, Michael
Colam,
Bridget
Lewis, Steff C.
Rothwell, Peter M.
Banning, Adrian
P.
Torgerson, David
Gough, Moira
Dellagrammaticas,
Demosthenes
Leigh-Brown, Anne
Liapis, Christos
Warlow,
Charles
