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临床试验/NCT05414877
NCT05414877尚未招募不适用

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

Beijing Tiantan Hospital0 个研究点目标入组 60 人开始时间: 2023年9月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
主要终点
Regional Cerebral Blood Flow

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • ASA classification 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

研究组 & 干预措施

Ephedrine

Experimental

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.

干预措施: Ephedrine (Drug)

Phenylephrine

Experimental

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.

干预措施: Phenylephrine (Drug)

norepinephrine

Experimental

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.

干预措施: Norepinephrine (Drug)

结局指标

主要结局

Regional Cerebral Blood Flow

时间窗: 10 minutes after entering the operating room; 10 minutes after intubation ;5 minutes after administration of vasopressors

This outcome is measured by Dynamic susceptibility contrast-enhanced perfusion-weighted imaging.

次要结局

  • Regional oxygen saturation index(10 minutes after entering the operating room; 10 minutes after intubation ;5 minutes after administration of vasopressors)

研究者

发起方
Beijing Tiantan Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ruquan Han

Professor & Director

Beijing Tiantan Hospital

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