Outcome of LA Versus GA for Staged CEA Prior To CABG

Sponsor

Thomas Aherne (Other)

Overall Status

Completed

CT.gov ID

NCT04901000

Collaborator

University Hospital Birmingham (Other)

Enrollment

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Carotid Artery Diseases Coronary Artery Disease Stroke	Procedure: Carotid endarterectomy

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.

Study Design

Study Type:

Observational

Actual Enrollment :

44 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Outcome of Local Versus General Anesthetic for Staged Carotid Endarterectomy Prior To CABG, Cohort Study

Actual Study Start Date :

Oct 1, 2011

Actual Primary Completion Date :

Sep 30, 2018

Actual Study Completion Date :

Sep 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
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.	Procedure: Carotid endarterectomy Carotid endarterectomy prior to CABG operations either under Local Anaesthetic or under General Anaesthetic.
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.	Procedure: Carotid endarterectomy Carotid endarterectomy prior to CABG operations either under Local Anaesthetic or under General Anaesthetic.

Arm

Intervention/Treatment

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.

Procedure: Carotid endarterectomy

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

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.

Procedure: Carotid endarterectomy

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

Outcome Measures

Primary Outcome Measures

Stroke [30 days]
a transient ischaemic attack (TIA), or a disabling stroke within 30 days of the carotid endarterectomy procedure.

Secondary Outcome Measures

Major bleeding [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 [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 [30 days]
Either neuropraxia that resolved with time or permanent injuries that resulted in disability.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Thomas Aherne
University Hospital Birmingham

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Thomas Aherne, Site Investigator, National University of Ireland, Galway, Ireland

ClinicalTrials.gov Identifier:

NCT04901000

Other Study ID Numbers:

University Hospital Birmingham

First Posted:

May 25, 2021

Last Update Posted:

May 25, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carotid Artery Diseases

Coronary Artery Disease

Study Results

No Results Posted as of May 25, 2021