Temporal Profile of Biomarkers Associated to Perioperative Stress Due to Carotid Endarterectomy Under Regional Anesthesia

• Conditions: Perioperative Stress

• Registration Number: NCT03957018
• Lead Sponsor: University of Pecs

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.

Detailed Description

We aim to explore the stress response of patients randomized according to different sedation protocols: (i) per os premedication only with alprazolam (BDZ group) or (ii) premedication with alprazolam combined with target control infusion (TCI) of propofol (BDZ+TCI) for awake carotid endarterectomy. A total of 50 consecutive patients with significant carotid artery stenosis will be enrolled into this prospective randomised study. All surgeries will be performed in regional anaesthesia. As premedication, all patients took 0.25 mg alprazolam 30 minutes before the procedure. After randomization 25 patients will be grouped to both arms of the study: either to "sedation with target controlled propofol infusion", or to "only premedication". Stress markers, such as cortisol plasma levels will be serially analysed: prior to surgery (T1), before (T2) and after release of carotid clamp (T3), at 2 (T4) and 24 post-operative hours (T5). Alprazolam levels were also measured before and after the surgery.

Study Timeline

• Study Start: 2014-11-28
• Primary Completion: 2018-11-23
• Status Verified: 2019-05
• Study First Submitted: 2019-05-16
• Study First Submitted QC: 2019-05-16
• Last Update Submitted: 2019-05-16
• Study First Posted: 2019-05-21
• Last Update Posted: 2019-05-21
• Study Completion: 2021-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

patients with significant symptomatic or asymptomatic carotid stenosis scheduled for carotid endarterectomy, written informed consent -

Exclusion Criteria

patient declines to participate in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
major vascular events	at 30th postoperative day	acute coronary syndrome, myocardial infarction, stroke, transient ischemic attack

Secondary Outcome Measures

Name	Time	Method
mortality and vascular events	5-year follow-up	death, acute coronary syndrome, myocardial infarction, stroke, transient ischemic attack

Trial Locations

Locations (1)

University of Pecs; 🇭🇺 Pécs, Baranya, Hungary