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临床试验/NCT01451294
NCT01451294Unknown不适用

The Effect of Phenylephrine Versus Ephedrine on Cerebral Perfusion During Carotid Endarterectomy

G.J. de Borst1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
cerebral perfusion (rSO2) measured using Near Infrared Spectroscopy

研究概览

简要总结

Carotid endarterectomy (CEA) is the recommended treatment for symptomatic high degree stenosis of the internal carotid artery (ICA). ICA obstruction is often associated with an impaired cerebral autoregulation, implicating that cerebral perfusion pressure becomes dependent on systemic blood pressure. Therefore, to maintain cerebral perfusion pressure in this type of patients intraoperative hypotension needs to be avoided. Different short-acting agents such as phenylephrine, (a drug with vasoconstrictive properties), or ephedrine (a drug with vasoconstrictive properties combined with an increase in heart rate) can be used to correct intra-operative hypotension. In healthy subjects these agents affect the cerebral perfusion differently despite an identical effect on the systemic blood pressure. Cerebral perfusion decreases after phenylephrine administration while it is preserved after the use of ephedrine. The optimal agent for correcting hypotension in CEA patients, and thus in a situation of an impaired cerebral autoregulation, is unknown.

Therefore, the investigators propose to perform a prospective study observing the effect of phenylephrine and ephedrine on cerebral perfusion to make a recommendation regarding the use of either phenylephrine or ephedrine during CEA.

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
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Ephedrine

Active Comparator

干预措施: Administration of ephedrine (Drug)

Phenylephrine

Active Comparator

干预措施: Administration of phenylephrine (Drug)

结局指标

主要结局

cerebral perfusion (rSO2) measured using Near Infrared Spectroscopy

时间窗: (day 1) Monitoring will take place only on the day of operation. No further follow-up. Timeframe is 1 day.

A continuous measurement during surgery will be performed. However for further analysis only a short time frame will be used.

次要结局

  • Blood velocity (Vmca) measured using transcranial Doppler(Within 18 months in consecutive patients undergoing carotid endarterectomy. Endpoints will only be assessed during actual surgery (approximately 90 minutes in total) no data will be assessed during follow-up.)

研究者

发起方
G.J. de Borst
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

G.J. de Borst

Vascular surgeon; Head of cerebrovascular surgical programme.

UMC Utrecht

研究点 (1)

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