Actively Recruiting

Age: 18Years - 100Years
All Genders
ID04347785

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

Led by Universidade do Porto · Updated on 2020-04-15

206

Participants Needed

1

Research Sites

521 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to identify factors that predict neurologic deficits occurring during carotid endarterectomy (CEA) with regional anesthesia, a procedure for carotid artery stenosis. It addresses the risk of neurologic problems caused by reduced brain blood flow during carotid artery clamping and the related risk of stroke after surgery. The study also examines the effects of these neurologic deficits around the time of surgery. The study observes patients who undergo carotid endarterectomy performed with regional anesthesia. It compares patients who experience neurologic changes after the artery is clamped with those who do not have such changes. All patients come from a tertiary referral center, and the control group is selected in a 1 to 1 ratio with the affected patients. Participants are monitored for neurologic symptoms during and after surgery. The main outcome being measured is the occurrence of stroke within five years after the procedure. Secondary outcomes include serious postoperative complications classified by the Clavien-Dindo scale within 30 days. Researchers evaluate medical records and neurologic exams to assess risks and consequences of neurologic deficits related to the surgery.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Undergoing carotid endarterectomy with regional anesthesia
  • Experiencing postclamping carotid neurologic deficit
Not Eligible

You will not qualify if you...

  • Having carotid stenting

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

Duration - 1 day

Participants undergo carotid endarterectomy with regional anesthesia and are observed for neurologic deficits during carotid cross-clamping and immediate post-operative recovery.

1 surgery day with immediate post-operative observation

Post-operative Follow-up

Duration - Up to 5 years

Participants are followed up to monitor for stroke and other complications after surgery.

Follow-up visits as scheduled over 5 years

Trial Site Locations

Total: 1 location

1

Faculdade de Medicina da Universidade do Porto

Porto, Portugal, 4200 - 319

Actively Recruiting

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Research Team

J

Joao P Rocha-Neves, MD, MSC; MPH, FEBVS

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Prognostic effect of troponin elevation in patients undergoing carotid endarterectomy with regional anesthesia - A prospective study.

Juliana Pereira-Macedo, João P Rocha-Neves, Marina F Dias-Neto...

https://pubmed.ncbi.nlm.nih.gov/31542388

Onset of Neurological Deficit During Carotid Clamping With Carotid Endarterectomy Under Regional Anesthesia Is Not a Predictor of Carotid Restenosis.

José D Vieira-Andrade, João P Rocha-Neves, Juliana P Macedo...

https://pubmed.ncbi.nlm.nih.gov/31382007

Short-term outcomes after selective shunt during carotid endarterectomy: a propensity score matching analysis.

Juliana Pereira-Macedo, Luís Duarte-Gamas, António Pereira-Neves...

https://pubmed.ncbi.nlm.nih.gov/37696419