免费获得国外相关药品，最快 1 个工作日回馈药物信息
出境医 / 临床实验 / Temporal Profile of Biomarkers Associated to Perioperative Stress Due to Carotid Endarterectomy Under Regional Anesthesia
Temporal Profile of Biomarkers Associated to Perioperative Stress Due to Carotid Endarterectomy Under Regional Anesthesia
Study Description
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.
Study Design
| 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 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- major vascular events [ Time Frame: at 30th postoperative day ]acute coronary syndrome, myocardial infarction, stroke, transient ischemic attack
Secondary Outcome Measures :
- mortality and vascular events [ Time Frame: 5-year follow-up ]death, acute coronary syndrome, myocardial infarction, stroke, transient ischemic attack
Eligibility Criteria
| 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
-
Contacts and Locations
Locations
| 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
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 16, 2019 | ||||
| First Posted Date | May 21, 2019 | ||||
| Last Update Posted Date | May 21, 2019 | ||||
| Actual Study Start Date | November 28, 2014 | ||||
| Actual Primary Completion Date | November 23, 2018 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
major vascular events [ Time Frame: at 30th postoperative day ] acute coronary syndrome, myocardial infarction, stroke, transient ischemic attack
|
||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures |
mortality and vascular events [ Time Frame: 5-year follow-up ] death, acute coronary syndrome, myocardial infarction, stroke, transient ischemic attack
|
||||
| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Temporal Profile of Biomarkers Associated to Perioperative Stress Due to Carotid Endarterectomy Under Regional Anesthesia | ||||
| Official Title | Temporal Profile of Biomarkers Associated to Perioperative Stress Due to Carotid Endarterectomy Under Regional Anesthesia | ||||
| 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 Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients with significant symptomatic or asymptomatic carotid stenosis scheduled for carotid endarterectomy. | ||||
| Condition | Perioperative Stress | ||||
| Intervention | Not Provided | ||||
| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment |
50 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | November 30, 2021 | ||||
| Actual Primary Completion Date | November 23, 2018 (Final data collection date for primary outcome measure) | ||||
| Eligibility 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 - |
||||
| Sex/Gender |
|
||||
| Ages | 18 Years to 100 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | |||||
| Listed Location Countries | Hungary | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03957018 | ||||
| Other Study ID Numbers | 4820-PTE | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
|
||||
| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Tihamér Molnár, University of Pecs | ||||
| Study Sponsor | University of Pecs | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | University of Pecs | ||||
| Verification Date | May 2019 | ||||
