Skip to main content
OpenTrials
Completed

NCT Number: NCT05665881

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital, Capital Medical University

Beijing, 100070, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 40-80 years.
  • elective carotid endarterectomy.
  • Signed informed consent

Exclusion criteria

  • American Society of Anesthesiologists physical status classification (ASA) IV - VI.
  • renal failure (estimated glomerular filtration rate less than 60 ml/min.m2).
  • cardiac arrhythmias.
  • Allergy to ephedrine, phenylephrine or norepinephrine, gadobutrol.
  • patients with preoperative TCD suggesting poor temporal window signal.
  • patients with severe carotid artery stenosis with no flow signal detected by TCD
  • Patients with tandem lesions of carotid artery stenosis

Treatment and study plan

Ephedrine

Drug

vasopressor

Phenylephrine

Drug

vasopressor

norepinephrine

Drug

vasopressor

Primary outcomes

  1. Changes in middle cerebral artery blood velocity

    Time frame: 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 outcomes

  1. Changes in regional oxygen saturation index

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 27, 2022
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.