Effects of Vasopressors on Cerebral Hemodynamics in Patients With Carotid Endarterectomy (MRI Part)

NCT ID: NCT05414877

Last Updated: 2023-08-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-30
• Study Completion Date: 2024-12-31

Brief 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.

Detailed 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.

Conditions

Carotid Endarterectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ephedrine

receive ephedrine (configured concentration 2 mg/mL). The individualized blood pressure control target was a 20% increase in baseline blood pressure, and the target blood pressure value was used as the basis for adjusting the dosing or pumping rate.

Group Type: EXPERIMENTAL

Ephedrine

Intervention Type: DRUG

vasopressor

Phenylephrine

receive intravenous infusion of phenylephrine (configured concentration 0.1 mg/mL) The individualized blood pressure control target was a 20% increase in baseline blood pressure, and the target blood pressure value was used as the basis for adjusting the dosing or pumping rate.

Group Type: EXPERIMENTAL

Phenylephrine

Intervention Type: DRUG

vasopressor

norepinephrine

intravenous infusion of norepinephrine (configured concentration of 6 μg/ml).The individualized blood pressure control target was a 20% increase in baseline blood pressure, and the target blood pressure value was used as the basis for adjusting the dosing or pumping rate.

Group Type: EXPERIMENTAL

Norepinephrine

Intervention Type: DRUG

vasopressor

Interventions

Ephedrine

vasopressor

Intervention Type: DRUG

Phenylephrine

vasopressor

Intervention Type: DRUG

Norepinephrine

vasopressor

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ruquan Han

Professor & Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ruquan Ruquan, M.D.,PhD

Role: STUDY_CHAIR

Department of Anesthesiology，Beijing Tiantan Hospital, Capital Medical University

Central Contacts

Ruquan Han, M.D.,PhD

Role: CONTACT

ruquan.han@gmail.com

01059976660

Other Identifiers

wxy20220526

Identifier Type: -

Identifier Source: org_study_id