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临床试验/NCT02739399
NCT02739399已完成4 期

The Dynamic Effects of Phenylephrine on Preload and Cardiac Output in Patients Under General Anaesthesia

Algemeen Ziekenhuis Maria Middelares1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2016年2月最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
26
试验地点
1
主要终点
Cardiac output

研究概览

简要总结

In patients under general anesthesia, episodes of hypotension are often treated with phenylephrine. The effect of phenylephrine is conventionally attributed to afterload increase.

The aim of the study is to describe the time course of the effects of phenylephrine on the cardiac preload and cardiac output, and to evaluate whether phenylephrine, as an exclusive alpha-mimetic, could be beneficial for preload optimisation.

详细描述

In consecutive patients scheduled for laparoscopic sigmoidectomy, all hemodynamic and respiratory variables are recorded electronically for subsequent offline analysis.

All patients are ventilated in volume control mode with a tidal volume of 8 ml/kg ideal body weight.

During steady-state Target Controlled Infusion (TCI) propofol/remifentanil anesthesia, when the Mean Arterial Blood Pressure (MAP) dropped below 80% of the awake state for at least 5 minutes, a phenylephrine bolus of 2 μg/kg is administered. If necessary this is repeated, or a continuous administration of phenylephrine is started at a rate of 10-30 μg/kg/u.

All patient manipulations during the procedure are electronically recorded and time stamped for subsequent off-line data analysis.

The first episode in each patient where phenylephrine is administered and in a period of at least 10 minutes when minimal or absent patient manipulation occurred, the hemodynamic variables are analysed to describe the effects of phenylephrine administration on the dynamic preload parameters and macro-hemodynamics.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • necessity for arterial blood pressure monitoring
  • necessity for central venous blood pressure monitoring

排除标准

  • unwilling or unable to grant written informed consent
  • cardiac arrythmia
  • contra-indication for phenylephrine
  • contra-indications for atropine
  • contra-indication for Total Intravenous Anesthesia

研究组 & 干预措施

Patient receiving phenylephrine 2ug/kg

Other

phenylephrine 2ug/kg in case of hypotension

干预措施: Phenylephrine (Drug)

结局指标

主要结局

Cardiac output

时间窗: perioperative

The evolution of the Cardiac Output in a time course \<20 minutes after administration

次要结局

  • Pulse Pressure Variation(perioperative)
  • End-Tidal CO2(perioperative)
  • Arterial Blood Pressure(perioperative)
  • central venous pressure(perioperative)

研究者

发起方
Algemeen Ziekenhuis Maria Middelares
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Alain Kalmar, MD, PhD

Dr

Algemeen Ziekenhuis Maria Middelares

研究点 (1)

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