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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05414877
Other study ID # wxy20220526
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 30, 2023
Est. completion date December 31, 2024

Study information

Verified date August 2023
Source Beijing Tiantan Hospital
Contact Ruquan Han, M.D.,PhD
Phone 01059976660
Email ruquan.han@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study was a single-center, exploratory, randomized controlled trial. First, the effects of ephedrine, phenylephrine, or norepinephrine on cerebral blood flow hemodynamics in CEA patients were evaluated using DSC-MRI to investigate the specific mechanisms of the three vasopressors on cerebral blood flow and oxygen metabolism in brain tissues.


Description:

Carotid endarterectomy is a procedure used to remove plaque from the common and internal carotid arteries and improve cerebral perfusion. Clinical studies have demonstrated the effectiveness of this procedure in both symptomatic and asymptomatic patients. intraoperative circulatory management challenges in CEA include the following: ① The incidence of preoperative combined coronary artery disease, hypertension and diabetes mellitus is relatively high in patients undergoing carotid endarterectomy, and there is a pathological basis for systemic vascular injury, increasing the risk of perioperative cardiovascular and cerebrovascular complications, such as myocardial ischemia and stroke. ② During the CEA procedure, the common carotid artery, internal carotid artery and external carotid artery and the superior thyroid artery need to be blocked respectively, the source of blood supply to the cerebral hemisphere on the operated side is reduced and depends only on the Willis circle supply. ③ Carotid sinus pressure receptor pull stimulation causes circulatory fluctuations. During CEA, a relatively high arterial pressure is required to provide adequate cerebral perfusion. However, achieving this target blood pressure level intraoperatively can be challenging due to given conditions, the presence of induction drugs and anesthetics. Therefore, it is particularly important to maintain cerebral hemodynamic stability and ensure tissue perfusion with intraoperative use of vasopressers. The purpose of this study was to evaluate the effects of ephedrine, phenylephrine, or norepinephrine on cerebral blood flow hemodynamic in CEA patients using DSC-MRI to investigate the specific mechanisms of the three boosting agents on cerebral blood flow and oxygen metabolism in brain tissues.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria: 1. age 40-80 years. 2. elective carotid endarterectomy. 3. Signed informed consent Exclusion Criteria: 1. ASA classification IV - VI. 2. renal failure (estimated glomerular filtration rate less than 60 ml/min.m2). 3. cardiac arrhythmias. 4. Allergy to ephedrine, phenylephrine or norepinephrine, gadobutrol. 5. patients with preoperative TCD suggesting poor temporal window signal. 6. patients with severe carotid artery stenosis with no flow signal detected by TCD 7. Patients with tandem lesions of carotid artery stenosis

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ephedrine
vasopressor
Phenylephrine
vasopressor
Norepinephrine
vasopressor

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Beijing Tiantan Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Regional Cerebral Blood Flow This outcome is measured by Dynamic susceptibility contrast-enhanced perfusion-weighted imaging. 10 minutes after entering the operating room; 10 minutes after intubation ;5 minutes after administration of vasopressors
Secondary Regional oxygen saturation index This outcome is measured by Near Infrared Spectroscopy 10 minutes after entering the operating room; 10 minutes after intubation ;5 minutes after administration of vasopressors
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