NCT01154738已完成3 期
Influence of Lidocaine on a Closed-Loop Anesthesia System
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Hopital Foch
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- administered dose of propofol during maintenance of anesthesia
研究概览
简要总结
The objective is to evaluate the sparing effect of Lidocaine on doses of propofol and remifentanil.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients ASA 1, 2 or 3 scheduled for a general anesthesia surgical procedure (abdominal surgery, urology, ENT major procedure) lasting between 1 and 3 hours
排除标准
- •age under 18 years
- •simultaneous general and loco-regional anesthesia
- •allergy to NSAID
- •treatment with verapamil, ketamine or gabapentin
- •patients receiving an opioid preoperatively
- •severe hepatic insufficiency
- •contra-indication to lidocaine
- •contra-indication to propofol or to remifentanil
- •history of central nervous system disease
- •patients receiving a psychotropic treatment
- •patients with a pace-maker
研究组 & 干预措施
Lidocaine
Experimental
Patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and Lidocaine
干预措施: Lidocaine (Drug)
Placebo
Placebo Comparator
patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and a placebo
干预措施: Placebo (Drug)
结局指标
主要结局
administered dose of propofol during maintenance of anesthesia
时间窗: day 1
次要结局
- delay (measured as minutes) between the end of propofol and remifentanil administration and the recovery from anesthesia(day 1)
- postoperative morphine requirement(day 1)
- incidence of postoperative nausea and vomiting(day 1)
- % of patients with an explicit memorisation of the intraoperative period(second postoperative day)
- administered dose of propofol during induction of anesthesia(day 1)
- administered doses of remifentanil during induction and maintenance of anesthesia(day 1)
- hemodynamic abnormalities requiring treatment(day 1)
- % of time with a BIS index between 40 and 60(day 1)
研究者
研究点 (1)
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