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临床试验/NCT00779844
NCT00779844终止4 期

Intravenous Anesthesia in Obese Patients: Propofol and Remifentanil Requirements

Hopital Foch2 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2008年12月最近更新:
适应症

试验速览

阶段
4 期
状态
终止
发起方
Hopital Foch
入组人数
63
试验地点
2
主要终点
Dose of propofol administered

研究概览

简要总结

Pharmacokinetic models for anesthetic agents are questionable. The objective of the study is to compare the propofol and remifentanil doses required to maintain the bispectral index in the range 40-60 in two groups of patients: obese patients and lean patients

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
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 scheduled for a bariatric coelioscopic surgical procedure (obese patients) or for an upper abdominal laparoscopic procedure (lean patients)

排除标准

  • age lower than 18 years,
  • pregnant woman,
  • presence of a central neurological disorder or a lesion cerebral, of a severe respiratory or hepatic insufficiency,
  • allergy to propofol, or to soja or to peanuts, or to sufentanil, or to remifentanil, or to morphine, or to a muscle myorelaxant, or to an excipient,
  • hypersensibility to sufentanil, or to remifentanil or to another derivate of fentanyl,
  • allergy to latex,
  • presence of a symptomatic gastroesophageal reflux,
  • patients receiving a psychotropic treatment or a agonist-antagonist opiate,
  • presence of predictive signs of difficult mask ventilation of difficult intubation (else than obesity)

结局指标

主要结局

Dose of propofol administered

时间窗: intraoperatively

次要结局

  • remifentanil requirement, hemodynamic profile, time to extubation, performances of the automated system of propofol and remifentanil deliver(intraoperatively)

研究者

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

研究点 (2)

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