Effects of Vasopressors on Cerebral Hemodynamics in Patients with Carotid Endarterectomy (TCD Part)

Not Applicable

Completed

• Conditions: Carotid Endarterectomy
• Interventions: Drug: Ephedrine; Drug: Phenylephrine; Drug: Norepinephrine

• Registration Number: NCT05665881
• Lead Sponsor: Beijing Tiantan Hospital

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 patients undergoing carotid endarterectomy were evaluated using TCD techniques 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 carotid endarterectomy 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 vasopressors.

The purpose of this study was to evaluate the effects of ephedrine, phenylephrine, or norepinephrine on cerebral blood flow hemodynamics in CEA patients using TCD techniques to investigate the specific mechanisms of the three boosting agents on cerebral blood flow and oxygen metabolism in brain tissues.

Study Timeline

• Study First Submitted: 2022-05-26
• Study Start: 2022-11-07
• Study First Submitted QC: 2022-12-16
• Study First Posted: 2022-12-27
• Primary Completion: 2024-09-24
• Study Completion: 2024-09-24
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-02
• Last Update Posted: 2024-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. age 40-80 years.
2. elective carotid endarterectomy.
3. Signed informed consent

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Exclusion Criteria

1. American Society of Anesthesiologists physical status classification (ASA) 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ephedrine	Ephedrine	Ephedrine group: receive ephedrine (configured concentration 2 mg/mL). The individualized blood pressure control target was a 10% increase in baseline blood pressure, and the target blood pressure value was used as the basis for adjusting the dosing or pumping rate.
Phenylephrine	Phenylephrine	Phenylephrine group: receive intravenous infusion of phenylephrine (configured concentration 0.1 mg/mL) The individualized blood pressure control target was a 10% increase in baseline blood pressure, and the target blood pressure value was used as the basis for adjusting the dosing or pumping rate.
norepinephrine	Norepinephrine	norepinephrine group: intravenous infusion of norepinephrine (configured concentration of 6 μg/ml).The individualized blood pressure control target was a 10% increase in baseline blood pressure, and the target blood pressure value was used as the basis for adjusting the dosing or pumping rate.

Primary Outcome Measures

Name	Time	Method
Changes in middle cerebral artery blood velocity	10 minutes after entering the operating room; 10 minutes after intubation ;5 minutes after administration of vasopressors	This outcome is measured by transcranial doppler ultrasound.

Secondary Outcome Measures

Name	Time	Method
Changes in regional oxygen saturation index	10 minutes after entering the operating room; 10 minutes after intubation ;5 minutes after administration of vasopressors	This outcome is measured by Near Infrared Spectroscopy

Trial Locations

Locations (1)

Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing, China