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

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.

Study Overview

• Status: Unknown
• Conditions: Perioperative Stress

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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• Hungary
  • Baranya
    • Pécs, Baranya, Hungary, 7624
      • Recruiting
      • University of Pecs
      • Contact: Tihamer Molnar, MD; Phone Number: +36302275814; Email: tihamermolnar@yahoo.com
      • Contact: Zsuzsanna Szabo, MD; Phone Number: +36303372180; Email: molnarneszabo@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

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Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
major vascular events	acute coronary syndrome, myocardial infarction, stroke, transient ischemic attack	at 30th postoperative day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality and vascular events	death, acute coronary syndrome, myocardial infarction, stroke, transient ischemic attack	5-year follow-up

Collaborators and Investigators

• Sponsor: University of Pecs

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2014
• Primary Completion (Actual): November 23, 2018
• Study Completion (Anticipated): November 30, 2021

Study Registration Dates

• First Submitted: May 16, 2019
• First Submitted That Met QC Criteria: May 16, 2019
• First Posted (Actual): May 21, 2019

Study Record Updates

• Last Update Posted (Actual): May 21, 2019
• Last Update Submitted That Met QC Criteria: May 16, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 4820-PTE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No