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临床试验/NCT02783846
NCT02783846已完成不适用

The Effects of Different Dexmedetomidine on the Propofol Requirement for Loss of Consciousness Undergoing Bispectral Index

General Hospital of Ningxia Medical University0 个研究点目标入组 73 人开始时间: 2016年6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
状态
已完成
发起方
入组人数
73
主要终点
The propofol requirement for pretreatment of dexmedetomidine by micro-pump until loss of consciousness

研究概览

简要总结

The purpose of this study is to evaluate the effects of different dexmedetomidine on the propofol requirement for loss of consciousness undergoing bispectral index.

详细描述

It has been shown that dexmedetomidine was an efficacious and safe adjuvant in general anaesthesia. Administration of dexmedetomidine during the preoperative period has been demonstrated to reduce the requirement of opioid analgesics and other sedative and hypnotic drugs.Therefore, the study is designed to measure the effect of intravenous dexmedetomidine premedication on the propofol dose requirement and bispectral index at loss of consciousness.

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
Triple (Participant, Investigator, Outcomes Assessor)

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

  • ASA physical status I-II
  • Aged 18-65 years
  • Body Mass Index 18.0~24.5 kg/m2
  • Without hearing impairment

排除标准

  • Bradycardia
  • Atrioventricular block
  • Neurologic disorder and recent use of psychoactive medication
  • Allergic to the drugs

研究组 & 干预措施

Group dexmedetomidine 1.0 µg/kg

Active Comparator

25 eligible patients are received dexmedetomidine 1.0 µg/kg intravenously for 10 minutes

干预措施: dexmedetomidine 1.0 µg/kg (Drug)

Group control

Placebo Comparator

24 eligible patients are received equal volumes of saline intravenously for 10 minutes

干预措施: normal saline (Other)

Group dexmedetomidine 0.5 µg/kg

Active Comparator

24 eligible patients are received dexmedetomidine 0.5 µg/kg intravenously for 10 minutes

干预措施: dexmedetomidine 0.5 µg/kg (Drug)

结局指标

主要结局

The propofol requirement for pretreatment of dexmedetomidine by micro-pump until loss of consciousness

时间窗: To infuse dexmedetomidine and saline completely ten minutes after

次要结局

  • The bispectral index values when patients loss of consciousness(To infuse dexmedetomidine and saline completely ten minutes after)

研究者

发起方
General Hospital of Ningxia Medical University
申办方类型
Other
责任方
Sponsor

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