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

Effects of Vasopressors on Cerebral Hemodynamics in Patients With Carotid Endarterectomy Under General Anesthesia(TCD Part): a Randomized Controlled Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05665881
Enrollment
90
Registered
2022-12-27
Start date
2023-01-07
Completion date
2024-09-24
Last updated
2025-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carotid Endarterectomy

Keywords

carotid endarterectomy, ephedrine, phenylephrine, norepinephrine, cerebrovascular circulation, cerebral blood flow hemodynamics

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.

Interventions

DRUGEphedrine

vasopressor

DRUGPhenylephrine

vasopressor

DRUGNorepinephrine

vasopressor

Sponsors

Beijing Tiantan Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

This study could not be blinded to the treating anesthesiologists. However, blinding was maintained for the patients and the assessors of outcome indicators. Postoperative follow-up was performed by a specially trained physician who did not have access to any information about the patients' cases and subgroups.

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in middle cerebral artery blood velocity10 minutes after entering the operating room; 10 minutes after intubation ;5 minutes after administration of vasopressorsThis outcome is measured by transcranial doppler ultrasound.

Secondary

MeasureTime frameDescription
Changes in regional oxygen saturation index10 minutes after entering the operating room; 10 minutes after intubation ;5 minutes after administration of vasopressorsThis outcome is measured by Near Infrared Spectroscopy

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026