Outcome of LA Versus GA for Staged CEA Prior To CABG

Overview

A retrospective analysis of all patients that underwent carotid endarterectomy (CEA) for stenotic disease – diagnosed at pre-operative investigation – prior to CABG as staged operation within 6- months. The rate of postoperative stroke and complications was compared between CEA performed under Local anaesthetic (LA) to those performed under General anaesthetic (GA).

Full Title of Study: “Outcome of Local Versus General Anesthetic for Staged Carotid Endarterectomy Prior To CABG, Cohort Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: September 30, 2018

Detailed Description

The primary outcome was the rate of postoperative stroke in patients that had staged CEA prior to CABG. This was defined as CEA within a period of 4 weeks prior to CABG. We retrospectively looked at those patients that fulfilled the inclusion criteria and had CEA performed either under LA (Group A) or under GA (Group B). We measured the 30 days' postoperative stroke rate as the main outcome. We also looked at the rate of intraoperative stroke. Additionally, we assessed the rate for developing nerve injuries and/or hematoma postoperatively. Finally, we examined the risk for developing postoperative stroke in patients with bilateral significant carotid artery disease that underwent surgery in one side.

Interventions

  • Procedure: Carotid endarterectomy
    • Carotid endarterectomy prior to CABG operations either under Local Anaesthetic or under General Anaesthetic.

Arms, Groups and Cohorts

  • Carotid Endarterectomy under Local Anaesthetic Pre-CABG
    • Patients that underwent carotid endarterectomy under local anaesthetic prior to coronary artery bypass operations in staged fashion within 6 months.
  • Carotid Endarterectomy under General Anaesthetic Pre-CABG
    • Patients that underwent carotid endarterectomy under general anaesthetic prior to coronary artery bypass operations in staged fashion within 6 months.

Clinical Trial Outcome Measures

Primary Measures

  • Stroke
    • Time Frame: 30 days
    • a transient ischaemic attack (TIA), or a disabling stroke within 30 days of the carotid endarterectomy procedure.

Secondary Measures

  • Major bleeding
    • Time Frame: 30 days
    • Major haematoma was defined as a significant bleeding that required the patient to go back to theatre for a secondary procedure.
  • Minor bleeding
    • Time Frame: 30 days
    • A minor hematoma was defined as bleeding that resulted in bruising and neck swelling without causing significant concerns to require a secondary procedur
  • Nerve injuries
    • Time Frame: 30 days
    • Either neuropraxia that resolved with time or permanent injuries that resulted in disability.

Participating in This Clinical Trial

Inclusion Criteria

  • All patients that had carotid endarterectomy performed in staged fashion within 6 months before a CABG operation. Exclusion Criteria:

  • Patients diagnosed with symptomatic carotid disease

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Thomas Aherne
  • Collaborator
    • University Hospital Birmingham
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Thomas Aherne, Site Investigator – National University of Ireland, Galway, Ireland

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