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Clinical Trials/NCT04347785
NCT04347785RecruitingNot Applicable

Preoperative, Intraoperative and Postoperative Predictors of Post-clamping Neurologic Deficits During Carotid Endarterectomy With Regional Anesthesia

Universidade do Porto1 site in 1 country206 target enrollmentStarted: January 1, 2011Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
206
Locations
1
Primary Endpoint
Stroke
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Patients undergoing carotid endarterectomy may suffer from neurologic deficits (ND) during the carotid cross-clamping due to cerebral hypoperfusion. An associated risk of postoperative stroke incidence is also well established.

The aim of this study is to evaluate the predictive factors associated with ND during CEA performed with RA. The perioperative implications of the ND were also evaluated.

Detailed Description

Patients undergoing carotid endarterectomy may suffer from neurologic deficits (ND) during the carotid cross-clamping due to cerebral hypoperfusion. An associated risk of postoperative stroke incidence is also well established.

The aim of this study is to evaluate the predictive factors associated with ND during CEA performed with RA. The perioperative implications of the ND were also evaluated.

All consecutive patients from a tertiary referral center who underwent CEA for carotid artery stenosis (CS) and consecutive patients who presented alterations in the neurologic examination after ICA clamping during CEA are selected. The control patients, submitted to the same procedure but with no neurologic alterations, are consecutively selected.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 100 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •carotid endarterectomy under regional anesthesia
  • •Postclamping carotid deficit

Exclusion Criteria

  • •carotid stenting

Outcomes

Primary Outcomes

Stroke

Time Frame: up to 5 years

An episode of neurological dysfunction caused by focal cerebral, spinal, or retinal infarction.

Secondary Outcomes

  • Clavien-Dindo Classification >3(30 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

João Rocha Neves

Consultant of Angiology and Vascular Surgery, MD/MSc, MPH epidemiology, FEBVS

Universidade do Porto

Study Sites (1)

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Predictors of Post-clamping Neurologic... | Clinical Trial