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OpenTrials
Completed

NCT Number: NCT04901000

Outcome of LA Versus GA for Staged CEA Prior To CABG

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).

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Key information

Conditions

Carotid Artery Diseases Arterial Occlusive Diseases Arteriosclerosis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Nervous System Diseases Stroke Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

carotid endarterectomy

Procedure

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

Primary outcomes

  1. Stroke

    Time frame: 30 days

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

Secondary outcomes

  1. 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.

  2. 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

  3. Nerve injuries

    Time frame: 30 days

    Either neuropraxia that resolved with time or permanent injuries that resulted in disability.

Sponsors and collaborators

Lead sponsor

Thomas Aherne

Other

Collaborators

  • University Hospital Birmingham

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
May 25, 2021
Registry last updated
May 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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