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

Carotid Endarterectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04347785
• Other study ID #: 248-18
• Status: Recruiting
• Start date: January 1, 2011
• Est. completion date: December 31, 2030

Study information

• Verified date: April 2020
• Source: Universidade do Porto
• Contact: Joao P Rocha-Neves, MD, MSC; MPH, FEBVS
• Phone: +351910486230
• Email: joaorochaneves[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 206
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• carotid endarterectomy under regional anesthesia

• Postclamping carotid deficit

Exclusion Criteria:

• carotid stenting

Related Conditions & MeSH terms

• Carotid Endarterectomy
• Neurologic Manifestations

Intervention

Procedure:
• carotid endarterectomy
shunt

Locations

Country	Name	City	State
Portugal	Faculdade de Medicina da Universidade do Porto	Porto

Sponsors (1)

Lead Sponsor	Collaborator
Universidade do Porto

Country where clinical trial is conducted

Portugal, 

References & Publications (2)

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.2019.09.0 — View 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: 10.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Major adverse cardiosvascular and cerebrovascular events	AMI, Stroke, AHF hospitalization, MALE, MACE, All-cause mortality	up to 5 years
Primary	Stroke	An episode of neurological dysfunction caused by focal cerebral, spinal, or retinal infarction.	up to 5 years
Secondary	Clavien-Dindo Classification >3	Postoperative event life threatining and requiring surgical, endoscopic or radiological intervention	30 days