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The GALA Trial General versus Local Anaesthesia for Carotid Endarterectomy

The GALA Trial General versus Local Anaesthesia for Carotid Endarterectomy. Michael J Gough on behalf of the GALA Trial Collaborators Discussants: Michael Gough, Michael Horrocks. Introduction. The Differing Effects of Regional and General Anaesthesia on

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The GALA Trial General versus Local Anaesthesia for Carotid Endarterectomy

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  1. The GALA TrialGeneral versus Local Anaesthesia for Carotid Endarterectomy Michael J Gough on behalf of the GALA Trial Collaborators Discussants: Michael Gough, Michael Horrocks

  2. Introduction • The Differing Effects of Regional and General Anaesthesia on • Cerebral Metabolism During Carotid Endarterectomy • J. McCleary, N. M. Dearden, D. H. Dickson, A. Watson, M. J. Gough • Eur J Vasc Endovasc Surg 1996, 12: 173-181 Local Versus General Anaesthesia in Carotid Endarterectomy: a Systematic Review of the Evidence C. Tangkanakul, C. E. Counsell, C. P. Warlow Eur J Vasc Endovasc Surg 1997, 13: 491-499

  3. Eligibility 15 CEAs/surgeon/year + 10 LA symptomatic or asymptomatic uncertainty re: best method co-operate with awake testing no other surgery randomise only once Randomisation Stratified by centre Telephone, Fax, Web Surgery GA: follow normal practice LA: shunt only on basis awake test testing Monitoring, GA shunts, patch endarterectomy, as per normal Follow-up Post-discharge/death form: 7 days 1 month: examination by “blind” independent neurologist 12 month FU: telephone, questionnaire, face-face Methods

  4. Primary end points: Stroke (retinal infarct) MI (fatal or non-fatal) Death Analysis intention-to-treat

  5. 99.9% FU

  6. Baseline Data Smoking, PAD, CAD, AF, DM all equal

  7. Compliance – No anaesthesia Consent early – Randomise late

  8. Compliance – Cross-overs

  9. Conversions

  10. 5% 10 5 4 4% 9 Other deaths 3% MI (fatal or non-fatal) 2% 70 66 Stroke (fatal or non-fatal) 1% 0% General 84/1752 (4.8%) Local 80/1771 (4.5%) Primary outcome events

  11. Stroke 3 (-10 to +16) MI -4 (-8 to +2) Death (any cause) 4 (-3 to +12) Stroke or death 4 (-9 to +18) Stroke, MI or death 3 (-11 to +17) -20 -10 0 10 20 Events prevented/1000 (95% CI) Favours General Favours Local Primary outcome events

  12. Other Complications

  13. Survival analysis

  14. Subgroups (primary outcome)

  15. OR (95% CI) 0.62 (0.24 to 1.59) 0.88 (0.64 to 1.23) 0.85 (0.63 to 1.16) Meta-analysis of 7 earlier trials GALA Meta-analysis including GALA Favours Local Favours General Implications of GALA Stroke & Death

  16. Implications of GALA Death OR (95% CI) 0.23 (0.05 - 1.01) 0.72 (0.40 - 1.30) 0.62 (0.36 – 1.07) Meta-analysis of 7 earlier trials GALA Meta-analysis including GALA Favours Local Favours General

  17. Primary outcome events(according to anaesthetic received) 79/1621 4.9% 64/1575 4.1% 8 events prevented/1000 (95% CI: -6 to +23)

  18. P<0.001 P<0.001 BP manipulated up Patch angioplasty Confounding Factors

  19. Conclusions • Primary outcomes: no reason to prefer LA or GA • Secondary outcomes: no influence on length of stay or QOL • Sub-groups: trend favouring LA for contralateral occlusion • Trends favouring LA: Peri-operative death Event free survival to 1 year • Implications: Offer both LA & GA for patient preference or medical reasons

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