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Clinical Trials/CTRI/2024/01/061964
CTRI/2024/01/061964CompletedNot Applicable

An observational clinical study to compare the influence of patient characteristics and type of anaesthesia on neurological outcomes after carotid endarterctomy

Nizams Institute of Medical Sciences1 site in 1 country40 target enrollmentStarted: February 1, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
To determine the in hospital neurological complications in the form of transient ischemic

Study Overview

Brief Summary

This is an observational study that will be conducted in patients who underwent carotid revascularization through carotid endarterectomy. The primary objective is  to determine the in hospital neurological complications in the form of transient ischemic attacks, major and minor strokes, cranial nerve injuries after carotid endarterectomy and its associated risk predictors in patients operated under general and regional anaesthesia. The secondary outcomes are to determine the incidence of cardiovascular complications like myocardial infarction, hemodynamically significant arrythmias and other complication like neck hematoma, need for reoperation, prolonged hospital stay and  to determine the total clamp time, procedure time. Patients information will be collected for demographic and clinical presentation, cardiovascular risk factors and comorbidities.  Type of anaesthesia will be decided by treating anaesthesiologist. The postoperative events that will be studied are transient ischemic attacks, major and minor strokes, cranial nerve palsies.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 80.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • All the patients with carotid artery stenosis operated for carotid endarterectomy for carotid revascularization.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

To determine the in hospital neurological complications in the form of transient ischemic

Time Frame: 7 days

attacks, major and minor strokes, cranial nerve injuries after carotid endarterectomy and

Time Frame: 7 days

its associated risk predictors in patients operated under general and regional anaesthesia

Time Frame: 7 days

Secondary Outcomes

  • 1. To determine the incidence of cardiovascular complications like myocardial infarction,(hemodynamically significant arrythmias and other complication like neck hematoma,)

Investigators

Sponsor Class
Research institution
Responsible Party
Principal Investigator
Principal Investigator

Rana Ather

Nizams Institute of Medical Sciences

Study Sites (1)

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