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临床试验/NCT04291794
NCT04291794Unknown4 期

Mean Arterial Pressure Reduction During the First Ten Minutes After General Anesthesia Induction Using Propofol Bolus or Tritiated Target-infusion: Superiority Randomized Controlled Trial

Brasilia University Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
120
试验地点
1
主要终点
Mean arterial pressure after 2 minutes

研究概览

简要总结

To compare haemodynamics and bispectral index values between conventional bolus propofol induction and target-controlled propofol infusion.

详细描述

To compare mean arterial pressure, heart rate and bispectral index values between conventional bolus propofol induction and target-controlled propofol infusion.

研究设计

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

盲法说明

Participant and outcomes Assessor will not know group allocation.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Scheduled for general anesthesia;
  • No contraindication for propofol.

排除标准

  • Data loss;
  • Protocol violation.

研究组 & 干预措施

Conventional bolus induction

Active Comparator

Hypnotic component of general anesthesia induction will be a single bolus of propofol 2mg/kg followed by turning on sevoflurane 2% at a fresh gas flow of 2L/min.

干预措施: Propofol (Drug)

Target-controlled induction

Experimental

Hypnotic component of general anesthesia induction will be target-controlled propofol infusion tritiated to loss of consciousness. Propofol target-controlled infusion will be maintained.

干预措施: Propofol Injection [Diprivan] (Drug)

结局指标

主要结局

Mean arterial pressure after 2 minutes

时间窗: 2 minutes after general anesthesia induction

Mean arterial pressure using non-invasive device

Mean arterial pressure after 4 minutes

时间窗: 4 minutes after general anesthesia induction minutes after general anesthesia induction

Mean arterial pressure using non-invasive device

Mean arterial pressure after 6 minutes

时间窗: 6 minutes after general anesthesia induction minutes after general anesthesia induction

Mean arterial pressure using non-invasive device

Mean arterial pressure after 8 minutes

时间窗: 8 minutes after general anesthesia induction minutes after general anesthesia induction

Mean arterial pressure using non-invasive device

Mean arterial pressure after 10 minutes

时间窗: 10 minutes after general anesthesia induction minutes after general anesthesia induction

Mean arterial pressure using non-invasive device

次要结局

  • Heart Rate after 4 minutes(4 minutes after general anesthesia induction)
  • Heart Rate after 6 minutes(6 minutes after general anesthesia induction)
  • Heart Rate after 8 minutes(8 minutes after general anesthesia induction)
  • Bispectral Index after 4 minutes(4 minutes after general anesthesia induction)
  • Heart Rate after 2 minutes(2 minutes after general anesthesia induction)
  • Bispectral Index after 6 minutes(6 minutes after general anesthesia induction)
  • Bispectral Index after 8 minutes(8 minutes after general anesthesia induction)
  • Heart Rate after 10 minutes(10 minutes after general anesthesia induction)
  • Bispectral Index after 2 minutes(2 minutes after general anesthesia induction)
  • Bispectral Index after 10 minutes(10 minutes after general anesthesia induction)

研究者

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

Gabriel Magalhaes Nunes Guimaraes

Voluntary professor

Brasilia University Hospital

研究点 (1)

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