Clinical trial NCT04347785: Predictors of Post-clamping Neurologic Deficits During Carotid Endarterectomy With Regional Anesthesia
Official title: Preoperative, Intraoperative and Postoperative Predictors of Post-clamping Neurologic Deficits During Carotid Endarterectomy With Regional Anesthesia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carotid Endarterectomy
Keywords: Carotid Stenosis
regional anesthesia
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post-clamping deficits were defined as any persistent alteration at neurologic examination during the CACC and resistant to hemodynamic adjustment

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.

Eligibility criteria: Inclusion Criteria:

* carotid endarterectomy under regional anesthesia
* Postclamping carotid deficit

Exclusion Criteria:

* carotid stenting

Primary outcomes:
measure: Stroke
timeFrame: up to 5 years
Secondary outcomes:
measure: Clavien-Dindo Classification >3
timeFrame: 30 days
Other outcomes:
measure: Major adverse cardiosvascular and cerebrovascular events
timeFrame: up to 5 years
Locations:
city: Porto
country: Portugal
facility: Faculdade de Medicina da Universidade do Porto
Study officials:
References:
citation: 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.
citation: 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.