General anaesthesia versus local anaesthesia for carotid surgery (GALA): a multicentre, randomised controlled trial

doi:10.1016/S0140-6736(08)61699-2

The Lancet

Volume 372, Issue 9656, 20 December 2008–2 January 2009, Pages 2132-2142

https://doi.org/10.1016/S0140-6736(08)61699-2 Get rights and content

Summary

Background

The effect of carotid endarterectomy in lowering the risk of stroke ipsilateral to severe atherosclerotic carotid-artery stenosis is offset by complications during or soon after surgery. We compared surgery under general anaesthesia with that under local anaesthesia because prediction and avoidance of perioperative strokes might be easier under local anaesthesia than under general anaesthesia.

Methods

We undertook a parallel group, multicentre, randomised controlled trial of 3526 patients with symptomatic or asymptomatic carotid stenosis from 95 centres in 24 countries. Participants were randomly assigned to surgery under general (n=1753) or local (n=1773) anaesthesia between June, 1999 and October, 2007. The primary outcome was the proportion of patients with stroke (including retinal infarction), myocardial infarction, or death between randomisation and 30 days after surgery. Analysis was by intention to treat. The trial is registered with Current Control Trials number ISRCTN00525237.

Findings

A primary outcome occurred in 84 (4·8%) patients assigned to surgery under general anaesthesia and 80 (4·5%) of those assigned to surgery under local anaesthesia; three events per 1000 treated were prevented with local anaesthesia (95% CI −11 to 17; risk ratio [RR] 0·94 [95% CI 0·70 to 1·27]). The two groups did not significantly differ for quality of life, length of hospital stay, or the primary outcome in the prespecified subgroups of age, contralateral carotid occlusion, and baseline surgical risk.

Interpretation

We have not shown a definite difference in outcomes between general and local anaesthesia for carotid surgery. The anaesthetist and surgeon, in consultation with the patient, should decide which anaesthetic technique to use on an individual basis.

Funding

The Health Foundation (UK) and European Society of Vascular Surgery.

Introduction

Patients with severe atherosclerotic stenosis at the internal carotid-artery origin have a high risk of ipsilateral ischaemic stroke. On the basis of previous randomised trials,¹ carotid endarterectomy is often advised, particularly after an ipsilateral transient ischaemic attack or non-disabling ischaemic stroke.² There is less benefit for asymptomatic carotid stenosis.³ Several complications may take place during or soon after carotid endarterectomy, including stroke in 5–7% of cases.⁴ Operative practices under local (or regional) anaesthesia may be safer than under general anaesthesia, partly because awake testing of brain function under local anaesthesia during carotid clamping alerts the surgeon to the need for a shunt more reliably than the various indirect techniques used under general anaesthesia. Consequently, fewer shunts are used. Although shunts should protect the brain from stroke that results from low cerebral-blood flow during carotid clamping, they can damage the arterial wall causing embolism to the brain.

Some randomised trials of carotid endarterectomy,⁵ and spinal and epidural anaesthesia for other types of surgery,⁶ have suggested more benefits of local than of general anaesthesia. However, sample sizes were often small in these studies, and some analyses combined different types of patients and procedures. Also, some studies were confounded by the use of regional anaesthesia as an adjunct to general anaesthesia. We have therefore undertaken a large randomised trial of general versus local anaesthesia for carotid endarterectomy.

Section snippets

Participants

We enrolled 3526 patients from 95 centres in 24 countries. Patients with symptomatic or asymptomatic internal carotid stenosis for whom open surgery with either local or general anaesthesia was advised were eligible. The planned sample size was 5000 patients, on the basis of a predicted one-third reduction in risk of a primary outcome under local compared with general anaesthesia (from 7·5% to 5%); this is a more-conservative treatment effect than suggested by the Cochrane meta-analysis.⁵

Results

Recruitment ran from June, 1999 to October, 2007. Database was locked on May 1, 2008. We used the first randomisation for ten patients who were inadvertently randomised twice. We removed one patient from the database because consent for the trial was not obtained, leaving 3526 for analysis (figure 1). Table 1 shows the baseline patient characteristics. We received post-surgery forms from all but two patients in each treatment group (99·9%).

Slightly more patients who were allocated to local

Discussion

The hypothesis that local anaesthesia is better than general anaesthesia for carotid endarterectomy is based on the idea that it is associated with more appropriate and less frequent shunt use, fewer cardiorespiratory complications, and preserved cerebrovascular autoregulation.¹⁰

However, in this study, although general anaesthesia was associated with a slightly higher risk than local anaesthesia of perioperative stroke, myocardial infarction, or death, this difference was not statistically

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Cervical Debranching: Regional versus General Anesthesia for Carotid-Subclavian Bypass. A Single Center Experience
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We report here the first cohort study comparing regional and general anaesthesia for left subclavian artery (LSA) revascularization.
A single-centre retrospective cohort study was performed, including all consecutive patients who underwent cervical debranching with carotid-subclavian bypass before aortic repair from February 2018 to May 2022. Patients were divided into 2 groups according to the type of anesthesia: Regional anesthesia (RA) versus general anesthesia (GA). Primary endpoints included the following: 1) technical success of RA and 2) neurological complications (NCs) (stroke and peripheral neurological lesions). Secondary endpoints included postoperative bleeding, wound complications, 30-day reintervention rate, and midterm events.
Eighty-three patients were included in the study. The mean age was 64 years (interquartile range [IQR]:13.5) and 69% were male. Thirty-seven patients (44.5%) were performed under RA. Technical success of RA was 89.2%. Two minor strokes (2.4%) were observed in the GA group (P = 0.199). Peripheral neurological disorders occurred in 4 patients (4.8%) (RA group n = 1 (2.7%), GA group n = 3 (6.5%), P = 0.491). 30-day complication rate was 27.7% (n = 23, GA: n = 15 (32.6%), RA: n = 8 (21.6%), P = 0.266). 30-day reintervention rate was 14.5% (n = 12) ten bleeding complications (12%) (RA group n = 3 (8.1%), GA group n = 7 (15.2%), P = 0.323), and 2 seroma evacuations (2.4%) in the RA group. The incidence of superficial wound infections was n = 6 (7.2%) (RA group n = 2 (5.4%), GA group n = 4 (8.7%), P = 0.565). Median follow-up time was 22 months (IQR 22 min/max 1–44).
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Comparison of Methods for Monitoring Intra-operative Cerebral Perfusion in Patients Undergoing Carotid Endarterectomy with Selective Shunting: A Systematic Review and Network Meta-Analysis of Randomised Controlled Trials and Cohort Studies
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This study aimed to analyse the influence of different methods of monitoring cerebral perfusion (MCP) on stroke, death, and use of intraluminal shunt during carotid endarterectomy (CEA).
A systematic review and network meta-analysis was conducted and registered in the PROSPERO registry (CRD42021246360). Medline, Embase, CENTRAL, and Web of Science were searched. Randomised controlled trials (RCTs) and cohort studies with > 50 participants that compared clinical outcomes for different MCP in patients undergoing CEA were included. Papers reporting one or a combination of two of the following MCPs were included in the analysis: awake testing (AT), near infrared spectroscopy (NIRS), electroencephalography (EEG), somatosensory evoked potential (SSEP), motor evoked potential (MEP), transcranial Doppler (TCD), and stump pressure (SP). A random effects network meta-analysis was performed using a binomial likelihood function with a specified logit link for peri-operative stroke or death and shunting as outcomes. Near infrared spectroscopy was excluded due to the lack of studies that could be used for statistical analysis.
Of 1 834 publications, 17 studies (15 cohort studies and two RCTs) including 21 538 participants were incorporated in the quantitative analysis. Electroencephalography was used in the largest number of participants (7 429 participants, six studies), while AT was used in the highest number of studies (10 studies). All monitoring modalities had worse outcomes with respect to stroke or death when compared with AT, with ORs ranging between 1.3 (95% credible interval [CrI] 0.2 – 10.9) for SSEP + MEP and 3.1 (CrI 0.3 – 35.0) for patients monitored with a combination of EEG and TCD. However, the wide CrI indicated that there is no statistically significant difference between the monitoring methods. Patients monitored with a combination of EEG and TCD had the lowest odds of being shunted, while SP had the highest odds of being shunted, also with no statistically significant difference.
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Fast track — ArticlesGeneral anaesthesia versus local anaesthesia for carotid surgery (GALA): a multicentre, randomised controlled trial

Summary

Background

Methods

Findings

Interpretation

Funding

Introduction

Section snippets

Participants

Results

Discussion

Lancet

Lancet

Lancet

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Eur J Vasc Endovasc Surg

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Br J Anaesth

Br J Anaesth

Fast track — Articles
General anaesthesia versus local anaesthesia for carotid surgery (GALA): a multicentre, randomised controlled trial