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Recruiting NCT04347785

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

Observational Carotid Endarterectomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: carotid endarterectomy.
Who it may be relevant to
Registry conditions: Carotid Endarterectomy. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Portugal
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Procedure carotid endarterectomy
    shunt

Primary outcome measures

  • Stroke [Time frame: up to 5 years]
Secondary outcome measures (1)
  • Clavien-Dindo Classification >3 [Time frame: 30 days]

Eligibility criteria

Inclusion criteria

  • carotid endarterectomy under regional anesthesia
  • Postclamping carotid deficit

Exclusion criteria

  • carotid stenting

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Portugal · 1 center
  • Faculdade de Medicina da Universidade do Porto — Porto

Publications

  • Pereira-Macedo J, Rocha-Neves JP, Dias-Neto MF, Andrade JPV. Prognostic effect of troponin elevation in patients undergoing carotid endarterectomy with regional anesthesia - A prospective study. Int J Surg. 2019 Nov;71:66-71. doi: 10.1016/j.ijsu.2019.09.015. Epub 2019 Sep 19. PMID 31542388
  • Vieira-Andrade JD, Rocha-Neves JP, Macedo JP, Dias-Neto MF. Onset of Neurological Deficit During Carotid Clamping With Carotid Endarterectomy Under Regional Anesthesia Is Not a Predictor of Carotid Restenosis. Ann Vasc Surg. 2019 Nov;61:193-202. doi: 10.1016/j.avsg.2019.05.025. Epub 2019 Aug 2. PMID 31382007
  • Pereira-Macedo J, Duarte-Gamas L, Pereira-Neves A, de Andrade JJP, Rocha-Neves J. Short-term outcomes after selective shunt during carotid endarterectomy: a propensity score matching analysis. Neurocirugia (Engl Ed). 2024 Mar-Apr;35(2):71-78. doi: 10.1016/j.neucie.2023.07.006. Epub 2023 Sep 9. PMID 37696419

Identifiers

NCT: NCT04347785 · 248-18

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗