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

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ClinicalTrials.gov Identifier: NCT03957018
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Tihamér Molnár, 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.

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Temporal Profile of Biomarkers Associated to Perioperative Stress Due to Carotid Endarterectomy Under Regional Anesthesia
Actual Study Start Date : November 28, 2014
Actual Primary Completion Date : November 23, 2018
Estimated Study Completion Date : November 30, 2021



Primary Outcome Measures :
  1. major vascular events [ Time Frame: at 30th postoperative day ]
    acute coronary syndrome, myocardial infarction, stroke, transient ischemic attack


Secondary Outcome Measures :
  1. mortality and vascular events [ Time Frame: 5-year follow-up ]
    death, acute coronary syndrome, myocardial infarction, stroke, transient ischemic attack



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with significant symptomatic or asymptomatic carotid stenosis scheduled for carotid endarterectomy.
Criteria

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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03957018


Locations
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Hungary
University of Pecs Recruiting
Pécs, Baranya, Hungary, 7624
Contact: Tihamer Molnar, MD    +36302275814    tihamermolnar@yahoo.com   
Contact: Zsuzsanna Szabo, MD    +36303372180    molnarneszabo@gmail.com   
Sponsors and Collaborators
University of Pecs

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Responsible Party: Tihamér Molnár, associate professor, University of Pecs
ClinicalTrials.gov Identifier: NCT03957018     History of Changes
Other Study ID Numbers: 4820-PTE
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No