Pilot Study of EEG Signs of Awakening Secondary to Injection of Sugammadex: Evaluation by Recording Bispectral Index and NeuroSENSE (Prospective, Double-blind Study)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Hopital Foch
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- modification of bispectral and neurosenses indices following sugammadex injection
研究概览
简要总结
It has been demonstrated that antagonism of neuromuscular blockade (neostigmine 0.04 mg kg-1) affects depth of anaesthesia with an increase in bispectral index (mean maximal change of 7.1) and middle-latency auditory evoked potentials (mean maximal change of 9.7).
Sugammadex has a quicker and more complete effect than neostigmine. This study aims to demonstrate if sugammadex administration increases bispectral and neurosense indices of the depth of anesthesia while patients still receive propofol-remifentanil iv anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 scheduled to receive general anesthesia with muscle relaxation
排除标准
- •contra-indication to the administration of propofol, remifentanil, rocuronium and to the use of the Bispectral Index or NeuroSense monitor
- •known drug allergy or hypersensitivity to a drug used in the study
- •history of central brain injury
- •patient treated with a psychotropic agent
- •patient with a pacemaker
- •severe renal insufficiency
- •treatment by toremifene, flucloxacillin or fusidic acid in the preoperative or immediate postoperative period
研究组 & 干预措施
Sugammadex - Nacl 9/00
Sugammadex - Nacl 9/00:
Patients will first receive sugammadex: 4 mg/kg when post tetanic count shows at least 1 or 2 responses; 2 mg/kg when Train of four shows at least 2 responses.
In case of complete reversal of myorelaxation, total intravenous anesthesia is stopped and patients are allowed to awake.
In the adverse case, patients wil receive Nacl 9/00 5 minutes after the first bolus of sugammadex.
The study is finished 5 minutes after this second injection and care is let to the choice of the anesthesiologist in charge.
干预措施: Sugammadex - Nacl 9/00 (Drug)
Nacl 9/00 - sugammadex
Nacl 9/00 - Sugammadex :
Patients wil first receive Nacl 9/00. In case of complete reversal of myorelaxation, total intravenous anesthesia is stopped and patients are allowed to awake.
In the adverse case, patients wil receive sugammadex 5 minutes after the first bolus of Nacl 9/00.
Sugammadex is given as: 4 mg/kg when post tetanic count shows at least 1 or 2 responses; 2 mg/kg when Train of four shows at least 2 responses.
The study is finished 5 minutes after the injection of sugammadex and care is let to the choice of the anesthesiologist in charge.
干预措施: Nacl 9/00 - sugammadex (Drug)
结局指标
主要结局
modification of bispectral and neurosenses indices following sugammadex injection
时间窗: day 1 after anesthesia
次要结局
- duration of stay in the postanesthesia care unit(day 1 after anesthesia)
- occurence of explicit memorisation(day 1 after anesthesia)
- score of White and Song during the three first postoperative hours(day 1 after anesthesia)
- residual myorelaxation in the post-anesthesia care unit(day 1 after anesthesia)
- clinical signs of recovery after sugammadex injection(day 1 after anesthesia)
- efficacy of sugammadex to reverse myorelaxation(day 1 after anesthesia)