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临床试验/NCT00922844
NCT00922844终止4 期

The Effect of Sevoflurane Versus Isoflurane on Vasopressor Need

UMC Utrecht1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2009年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
发起方
UMC Utrecht
入组人数
10
试验地点
1
主要终点
Total amount of the vasopressor phenylephrine that is needed to maintain blood pressure above 60 mmHg during 10 minutes of Cardiopulmonary bypass.

研究概览

简要总结

Aim of this study is to determine the effect of isoflurane versus sevoflurane on blood pressure and systemic vascular resistance.

详细描述

In modern anesthesia a variety of volatile anesthetics is available. In cardiac anesthesiology both isoflurane and sevoflurane are frequently used. At present the number of studies comparing the influence of isoflurane and sevoflurane on blood pressure and systemic vascular resistance is limited. Moreover, the results presented in the available literature are inconsistent. The decision as to which of both volatiles should be used during cardiac surgery is not evidence-based, but is based on personal preference of the anesthesist. The most reliable way to compare the effects of isoflurane and sevoflurane on blood pressure and systemic vascular resistance is a randomized controlled trial in patients during Cardiopulmonary bypass (CPB).

研究设计

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

入排标准

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

入选标准

  • competent adult patients (18 years or older)undergoing elective coronary artery bypass grafting with the use of the cardiopulmonary bypass.

排除标准

  • Patients undergoing valve surgery or combined surgical procedures (e.g. coronary artery bypass grafting in combination with valve reconstruction.
  • uncontrolled hypertension
  • a poor left ventricular function
  • renal failure
  • a body mass index of > 25
  • history of cerebrovascular accident, transient ischemic accident or carotid artery stenosis.

研究组 & 干预措施

Sevoflurane

Active Comparator

Administration of the volatile anesthetic Sevoflurane.

干预措施: Sevoflurane and isoflurane (Drug)

Isoflurane

Active Comparator

Administration of the volatile anesthetic Isoflurane.

干预措施: Sevoflurane and isoflurane (Drug)

结局指标

主要结局

Total amount of the vasopressor phenylephrine that is needed to maintain blood pressure above 60 mmHg during 10 minutes of Cardiopulmonary bypass.

时间窗: 10 minutes

次要结局

  • Mean blood pressure throughout the 10 minute periods, the need for a stronger vasopressor (norepinephrine) and the inability to keep mean blood pressure below 75 mmHg at MAC 0.6.(10 minutes)

研究者

发起方
UMC Utrecht
申办方类型
Other
责任方
Principal Investigator
主要研究者

D van Dijk

Dr

UMC Utrecht

研究点 (1)

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