Determination of Target of Adequate Partial Neuromuscular Blockade for Electrophysiologic Monitoring During Microvascular Decompression Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Lateral spread response
研究概览
简要总结
There have been reports of monitoring LSR during MVD surgery helps predicting the clinical outcome of MVD.However, there have been no evidence of which degree of partial neuromuscular blockade should be performed or no neuromuscular blockade could be performed during LSR monitoring. Therefore, we performed a randomized controlled trial to evaluate the effect of different degree of partial neuromuscular blockade, including no neuromuscular blockade on the LSR monitoring for MVD surgery.
详细描述
Hemifacial spasm develops by vascular compression of facial nerve at the root exit zone from brain stem. Microvascular decompression (MVD) is known for its curative treatment. Lateral spread response (LSR) is a kind of pathologic electromyographic (EMG) wave form which develops when facial nerve is compressed by vessel. There have been reports of monitoring LSR during MVD surgery helps predicting the clinical outcome of MVD.
As neuromuscular blockade during LSR monitoring decreases the amplitude of EMG, partial neuromuscular blockade is usually maintained during general anesthesia for MVD. However, there have been no evidence of which degree of partial neuromuscular blockade should be performed or no neuromuscular blockade could be performed during LSR monitoring. Therefore, we performed a randomized controlled trial to evaluate the effect of different degree of partial neuromuscular blockade, including no neuromuscular blockade on the LSR monitoring for MVD surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Those who undergo microvascular decompression by diagnosis of hemifacial spasm in our institution
排除标准
- •Patients were excluded from the study if they had any of following: severe cardiopulmonary disorder with hemodynamic unstability (pulmonary hypertension, cardiomyopathy, mechanical ventilation, American Society of Anesthesiologists physical status III or more), severe hepatic or renal disease.
- •Those who can not undergo MEP monitoring due to central or peripheral neuromuscular disease, e.g. cerebral palsy, myasthenia gravis, acute spinal injury, neurologic shock
研究组 & 干预措施
TOF count-guided group
Using partial neuromuscular blockade to maintain train-of-four response of two, TOF response measured by the neuromuscular transmission module (NMT module)
干预措施: TOF count-guided partial NMB (Other)
T1/Tc amplitude group
Using partial neuromuscular blockade to maintain T1/Tc amplitude of 50%, T1/Tc amplitude measured by the neuromuscular transmission module (NMT)
干预措施: T1/Tc guided partial NMB (Other)
No neuromuscular blockade group
to maintain no neuromuscular blockade during LSR monitoring except the intubation dose during anesthetic induction
干预措施: No NMB (Other)
结局指标
主要结局
Lateral spread response
时间窗: after dura closure (150 min after anesthetic induction)
Lateral spread response of electromyography measured by electrophysiologist after dura closure (150 min after anesthetic induction)
Lateral spread response
时间窗: baseline (30 min after anesthetic induction)
Lateral spread response of electromyography measured by electrophysiologist at baseline (30 min after anesthetic induction)
Lateral spread response
时间窗: before dura opening (45 minute after anesthetic induction)
Lateral spread response of electromyography measured by electrophysiologist before dura opening
Lateral spread response
时间窗: after dura opening (60 min after anesthetic induction)
Lateral spread response of electromyography measured by electrophysiologist after dura opening (one hour after anesthetic induction)
Lateral spread response
时间窗: before facial nerve decompression (90 minutes after anesthetic induction)
Lateral spread response of electromyography measured by electrophysiologist before facial nerve decompression (90 minutes after anesthetic induction)
Lateral spread response
时间窗: after facial nerve decompression (120 min after anesthetic induction)
Lateral spread response of electromyography measured by electrophysiologist after facial nerve decompression (2 hour after anesthetic induction)
次要结局
- heart rate (beats/min)(Baseline (30min), Before dura open (45 min), After dura open (60 min), Before decompression (90 min), After decompression (120 min), After dura close (150 min after anesthetic induction))
- pulse oximetry (oxygen saturation, %)(Baseline (30min), Before dura open (45 min), After dura open (60 min), Before decompression (90 min), After decompression (120 min), After dura close (150 min after anesthetic induction))
- Train-of-four response(Baseline (30min), Before dura open (45 min), After dura open (60 min), Before decompression (90 min), After decompression (120 min), After dura close (150 min after anesthetic induction))
- T1/Tc amplitude(Baseline (30min), Before dura open (45 min), After dura open (60 min), Before decompression (90 min), After decompression (120 min), After dura close (150 min after anesthetic induction))
- incidence of patients' spontaneous movements or respiration(Baseline (30min), Before dura open (45 min), After dura open (60 min), Before decompression (90 min), After decompression (120 min), After dura close (150 min after anesthetic induction))
- Mean blood pressure (mmHg)(Baseline (30min), Before dura open (45 min), After dura open (60 min), Before decompression (90 min), After decompression (120 min), After dura close (150 min after anesthetic induction))
研究者
Jeong Jin Lee
Professor
Samsung Medical Center