Effect of Intraoperative Muscle Relaxation Reversal on the Success Rate of Motor Evoked Potential Recording
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- The success rate of TceMEPs
研究概览
简要总结
Transcranial motor evoked potential (TcMEP) monitoring is conventionally performed during surgery without or with minimal neuromuscular blockade (NMB) because of its potential interference with signal interpretation.The feasibility of TcMEP interpretation was assessed during partial NMB in adult neurosurgical patients. However, partial NMB may interfere record of TcMEP monitoring. Sugammadex is the first highly selective antagonist that can reverse NMB. This study aims to evaluate the success rate of intraoperative muscle relax reversal by sugammadex on intraoperative TceMEP recording.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range from 18 to 65 years old
- •American Society of Anesthesiologists (ASA) physical status I to II
排除标准
- •BMI ≥35 kg/m-2
- •History of epilepsy or use of antiepileptic drugs
- •Personal history or family history of malignant hyperthermia
- •Allergies to sugammadex; NMBs or other medication(s) used during general anesthesia
- •Hemoglobin <110 g/L
- •TceMEP stimulation or recorded site infection
- •Preoperative neurological dysfunction in both upper extremities
- •Cardiac pacemaker
- •Pregnancy and lactation
研究组 & 干预措施
Sugammadex group
干预措施: Sugammadex (Drug)
control group
干预措施: Saline (Drug)
结局指标
主要结局
The success rate of TceMEPs
时间窗: 5 minutes after first performing of TceMEPs
The success rate of Transcranial motor evoked potentials monitoring（TceMEPs）
次要结局
- Recurrence of neuromuscular blockade(time of extubation)
- Adverse effects of sugammadex(during the surgery)
- Mean value of amplitudes of TceMEPs(5, 10, 20, 30 and 60 minutes after first performing of TceMEPs)
- Incidence of body movement(during the surgery)
- Thresholds of TceMEPs(5 minutes after first performing of TceMEPs)
- respiratory pressure(during the surgery)
- Mean value of latencies of TceMEPs(5, 10, 20, 30 and 60 minutes after first performing of TceMEPs.)
研究者
Ruquan Han
Professor
Beijing Tiantan Hospital