NCT03957018

Brief Summary

Carotid endarterectomy (CEA) is a high risk surgical and anesthesiological procedure. It is an essential part of stroke-prevention strategies, however the incidence of CEA related peri-operative stroke is between 5% and 10%. These procedures can be performed either in general or regional anaesthesia. We hypothesized that an appropriate awake sedation is able to decrease patient's distress and an improved satisfaction can be reached.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 28, 2014

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 21, 2019

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

May 21, 2019

Status Verified

May 1, 2019

Enrollment Period

4 years

First QC Date

May 16, 2019

Last Update Submit

May 16, 2019

Conditions

Perioperative Stress

Outcome Measures

Primary Outcomes (1)

  • major vascular events

    acute coronary syndrome, myocardial infarction, stroke, transient ischemic attack

    at 30th postoperative day

Secondary Outcomes (1)

  • mortality and vascular events

    5-year follow-up

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with significant symptomatic or asymptomatic carotid stenosis scheduled for carotid endarterectomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pecs

Pécs, Baranya, 7624, Hungary

RECRUITING

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

May 16, 2019

First Posted

May 21, 2019

Study Start

November 28, 2014

Primary Completion

November 23, 2018

Study Completion

November 30, 2021

Last Updated

May 21, 2019

Record last verified: 2019-05

Locations

HU(1)