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

Capital Medical University

Status: Not yet enrolling

Conditions: Carotid Endarterectomy

Treatments: Drug: Ephedrine; Drug: Phenylephrine; Drug: Norepinephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT05414877

wxy20220526

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups

Ephedrine

Experimental group

Description:

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.

Treatment:

Drug: Ephedrine

Phenylephrine

Experimental group

Description:

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.

Treatment:

Drug: Phenylephrine

norepinephrine

Experimental group

Description:

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.

Treatment:

Drug: Norepinephrine