Predictors of Post-clamping Neurologic Deficits During Carotid Endarterectomy With Regional Anesthesia

Recruiting

• Conditions: Carotid Endarterectomy
• Interventions: Procedure: carotid endarterectomy

• Registration Number: NCT04347785
• Lead Sponsor: Universidade do Porto

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 Timeline

• Study Start: 2011-01-01
• Study First Submitted: 2020-03-26
• Status Verified: 2020-04
• Study First Submitted QC: 2020-04-13
• Last Update Submitted: 2020-04-13
• Study First Posted: 2020-04-15
• Last Update Posted: 2020-04-15
• Primary Completion: 2020-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 206

Inclusion Criteria

• carotid endarterectomy under regional anesthesia
• Postclamping carotid deficit

Exclusion Criteria

• carotid stenting

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neurologic deficit	carotid endarterectomy	All consecutive patients from a tertiary referral center who underwent CEA for carotid artery stenosis who presented alterations in the neurologic examination after ICA clamping during CEA area selected
control	carotid endarterectomy	The control patients are submitted to the same procedure but with no neurologic alterations, are consecutively selected. a 1 to 1 ratio is used

Primary Outcome Measures

Name	Time	Method
Stroke	up to 5 years	An episode of neurological dysfunction caused by focal cerebral, spinal, or retinal infarction.

Secondary Outcome Measures

Name	Time	Method
Clavien-Dindo Classification >3	30 days	Postoperative event life threatining and requiring surgical, endoscopic or radiological intervention

Trial Locations

Locations (1)

Faculdade de Medicina da Universidade do Porto; 🇵🇹 Porto, Portugal