Plexus anesthesia versus general anesthesia in patients for carotid endarterectomy with patch angioplasty: Protocol for a systematic review with meta-analyses and Trial Sequential Analysis of randomized clinical trials

M S Marsman; J Wetterslev; F Keus; D van Aalst; F G van Rooij; J M M Heyligers; F L Moll; A Kh Jahrome; P W H E Vriens; G G Koning

doi:10.1016/j.isjp.2019.12.002

Plexus anesthesia versus general anesthesia in patients for carotid endarterectomy with patch angioplasty: Protocol for a systematic review with meta-analyses and Trial Sequential Analysis of randomized clinical trials

Int J Surg Protoc. 2020 Jan 17:19:1-7. doi: 10.1016/j.isjp.2019.12.002. eCollection 2020.

Authors

M S Marsman¹, J Wetterslev², F Keus³, D van Aalst⁴, F G van Rooij⁵, J M M Heyligers⁶, F L Moll⁷, A Kh Jahrome⁸, P W H E Vriens⁶, G G Koning⁹

Affiliations

¹ Department of Vascular Surgery, Rijnstate Hospital, Arnhem, the Netherlands.
² Copenhagen Trial Unit, Center for Clinical Intervention Research, Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark.
³ Department of Critical Care, University of Groningen, University Medical Center Groningen, the Netherlands.
⁴ Department of Anaesthesiology, Radboud University Medical Center Nijmegen, Nijmegen, the Netherlands.
⁵ Department of Neurology, Medical Center Leeuwarden, Leeuwarden, the Netherlands.
⁶ Department of Vascular Surgery, Elisabeth-TweeSteden Hospital, Tilburg, the Netherlands.
⁷ Department of Vascular Surgery, University Medical Center Utrecht, Utrecht, the Netherlands.
⁸ Department of Vascular Surgery, Medical Center Leeuwarden, Leeuwarden, the Netherlands.
⁹ Department of Vascular Surgery, Ikazia Hospital, Rotterdam, the Netherlands.

Abstract

Introduction: Traditional carotid endarterectomy is considered to be the standard technique for prevention of a new stroke in patients with a symptomatic carotid stenosis. Use of plexus anesthesia or general anesthesia in traditional carotid endarterectomy is, to date, not unequivocally proven to be superior to one other. A systematic review is needed for evaluation of benefits and harms to determine which technique, plexus anesthesia or general anesthesia is more effective for traditional carotid endarterectomy in patients with symptomatic carotid stenosis.

Methods and outcomes: The review will be conducted according to this protocol following the recommendations of the 'Cochrane Handbook for Systematic Reviews' and reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses. Randomized Clinical Trials comparing plexus anesthesia versus general anesthesia in traditional carotid endarterectomy will be included. Primary outcomes will be postoperative death and/ or stroke (<30 days) and serious adverse events. Secondary outcomes will be non-serious adverse events.We will primarily base our conclusions on meta-analyses of trials with overall low risk of bias. We will use Trial Sequential Analysis to assist the evaluation of imprecision in Grading of Recommendations Assessment, Development and Evaluation. However, if pooled point-estimates of all trials are similar to pooled point-estimates of trials with overall low risk of bias and there is lack of a statistical significant interaction between estimates from trials with overall high risk of bias and trials with overall low risk of bias we will consider the Trial Sequential Analysis adjusted confidence interval precision of the estimate achieved in all trials as the result of our meta-analyses.

Ethics and dissemination: The proposed systematic review will collect and analyze secondary data from already performed studies therefore ethical approval is not required. The results of the systematic review will be disseminated by publication in a peer-review journal and submitted for presentation at relevant conferences.