Intraoperative Reversal of Muscle Relaxants During Transcranial Electrical Motor Evoked Potential Monitoring in Patients Undergoing Spinal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- The amplitude of MEP
研究概览
简要总结
Transcranial motor evoked potential (TcMEP) monitoring is conventionally performed during neurosurgical procedures without or with minimal neuromuscular blockade (NMB) because of its potential interference with signal interpretation. However, full blockade offers increased anesthetic management options and facilitates surgery. Here, investigators want to assess the effect of Sugammadex during TcMEP in adult patients. Sugammadex is designed to encapsulate rocuronium and reverse rocuronium-induced neuromuscular blockade. 64 patients undergoing thoracic or lumbar spinal surgery will be randomly allocated into sugammadex group or control group under a ratio of 1 to 1. Patients will receive either continuous infusion of rocuronium to produce blockade maintained at least two twitches in Train-of-Four (TOF), rocuronium infusion will be discontinued and 2 mg/kg of sugammadex will be infused while dura opening in sugammadex group. Whereas no muscle relaxant will be given after anesthetic induction in control group. The primary aim of this study is to compare mean value of amplitudes of TcMEPs in abductor pollicis brevis muscles of both upper extremities 5 minutes after dura opening.
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
- •18-65 years
- •ASA status I-II
- •Patients undergo thoracic or lumbar spinal surgery
- •tcMEP monitoring during the surgery
- •Informed consent signed by patients
排除标准
- •BMI ≥35 Kg/m-2
- •history of epilepsy or use of antiepileptic drugs, neuromuscular disorder(s)
- •history or family history of malignant hyperthermia
- •allergies to sugammadex, NMBs or other medication(s) used during general anesthesia
- •anemia, hemoglobin <110g/L,
- •TcMEPs stimulate or record site infection
- •preoperative neurological dysfunction in both upper extremities
- •cardiac pacemaker
- •pregnancy and breast-feeding
研究组 & 干预措施
Sugammadex group
干预措施: Sugammadex (Drug)
结局指标
主要结局
The amplitude of MEP
时间窗: 5 minutes after dura opening
mean value of amplitudes of TceMEPs in abductor pollicis brevis muscles of both upper extremities
次要结局
- The latencies of MEPs(5, 10, 20, 30 and 60 minutes after dura opening.)
- Respiratory parameters(during the surgery)
- Adverse effects of sugammadex(during and 24 hours after the surgery)
- Incidence of body movement(during the surgery)
- The amplitude of MEP(10, 20, 30 and 60 minutes after dura opening)
- Motor function assessment(5 days after surgery)
- Total bleeding volume(during the surgery)
- Recurrence of neuromuscular blockade(At the end of surgery)
研究者
Ruquan Han
Principal Investigator
Beijing Tiantan Hospital