Effect of Peroperative Intravenous Infusion of Lignocaine on the Quality of Postoperative Sleep
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 主要终点
- Time ratio between rapid eye movement sleep(REM) + Stage 3 sleep / Stage 1 + Stage 2 sleep
研究概览
简要总结
The aim of this clinical trial is to study the effect of an intravenous infusion of lidocaïne in a multimodal analgesic protocol on the architecture sleep during the first postoperative night.
详细描述
To study the effect of lidocaïne, we plan to include 40 patients, randomized in 2 groups, undergoing open prostate surgery in this randomized placebo-controlled trial.
Before anesthesia induction, these patients receive an intravenous lidocaine infusion (bolus 1,5 mg.kg-1 followed by a continuous infusion of 2mg.kg-1.h during 24 hours) or an equal volume of placebo. Then the anesthesia is induced with propofol, sufentanil et rocuronium. The postoperative analgesia is provided by paracetamol, tramadol and patient-controlled analgesia (PCA) with morphine or oral oxycodone. A polysomnography is registred on the preoperative night and on the first postoperative night.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Radical prostatectomy
排除标准
- •BMI > 30
- •Neurologic/psychiatric diseases or therapeutics, seizyres
- •Cardiac disease, second or third degree atrioventricular block
- •Obstructive sleep apnea syndrome
- •History of liver or renal insufficiency
- •and any contraindication to the anesthetic protocol of the study.
研究组 & 干预措施
Lidocaïne 2%
Bolus 0.075ml/kg/h, following by continuous infusion 0.1ml/kg/h during surgery and 0.066ml/kg/h during 24h
干预措施: Lidocaïne 2% (Drug)
Placebo (for Lidocaïne)
Bolus 0.075ml/kg/h, following by continuous infusion 0.1ml/kg/h during surgery and 0.066ml/kg/h during 24h
干预措施: Placebo (for Lidocaïne) (Drug)
结局指标
主要结局
Time ratio between rapid eye movement sleep(REM) + Stage 3 sleep / Stage 1 + Stage 2 sleep
时间窗: Postoperaty day 1
次要结局
- Cumulative Opioid use(Postoperaty day 1)
- Sleep latence(Postoperaty day 1)
- Sleep time(Postoperaty day 1)
- Quality of analgesia (Visual Analogic Scale)(Postoperaty day 1)
研究者
Jean François Brichant
Professor
University of Liege