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临床试验/NCT00896714
NCT00896714已完成不适用

Impact of Environmental and Demographic Factors on Pre-operative Doses of Anesthetic Agents (Prospective Multicenter Study)

Hopital Foch8 个研究点 分布在 1 个国家目标入组 3,278 人开始时间: 2009年5月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Hopital Foch
入组人数
3,278
试验地点
8
主要终点
The dose of propofol required to maintain BIS (bispectral index) between 40 and 60 during maintenance of anesthesia

研究概览

简要总结

The main objective of the study is to analyze the influence of several environmental (i.e., timing: seasonal, circadian) and demographic conditions (i.e., age, gender, menstrual cycle) on anesthetic drug requirements (hypnotic and opiate).

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing scheduled surgery under general anesthesia, agreeing to participate in the study

排除标准

  • Age under 18 years
  • Pregnancy, breastfeeding woman
  • Allergy to propofol, soybeans or peanuts
  • Allergy to sufentanil, remifentanil, morphine,
  • Allergy to a muscle relaxant or to any of its excipients
  • Known hypersensitivity to sufentanil, remifentanil, or to other derivates of fentanyl
  • History of central neurological disorder or brain injury
  • Patient with dementia
  • Patient with pacemaker
  • Patient receiving psychotropic drugs or morphine agonist-antagonists
  • Surgery on the skull and/or operating position preventing the use of a bispectral index sensor in suitable conditions

研究组 & 干预措施

Closed loop anesthesia

Experimental

干预措施: Closed loop anesthesia (Device)

结局指标

主要结局

The dose of propofol required to maintain BIS (bispectral index) between 40 and 60 during maintenance of anesthesia

时间窗: during anesthesia

次要结局

  • Wake up time(intraoperative period)
  • Remifentanil dose requirements for maintenance of anesthesia(intraoperative period)
  • Remifentanil dose required for anesthesia induction(intraoperative period)
  • Propofol and remifentanil requirements according to the surgical technique(post-operative period)
  • Analysis of subgroup of patients according to their clinical status(post-operative period)
  • Analysis of subgroup of patients according to the surgical approach(post-operative period)
  • Analysis of subgroup of patients according to their pathology(post-operative period)
  • Propofol dose required for anesthesia induction(intraoperative period)
  • Explicit memorisation(post-operative period)

研究者

发起方
Hopital Foch
申办方类型
Other
责任方
Sponsor

研究点 (8)

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