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临床试验/NCT01613781
NCT01613781已完成不适用

Determination of Target of Adequate Partial Neuromuscular Blockade With Sevoflurane Anesthesia for Electrophysiologic Monitoring During Microvascular Decompression Surgery

Samsung Medical Center2 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2012年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
61
试验地点
2
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 during LSR monitoring under sevoflurane anesthesia. Therefore, the investigators performed a randomized controlled trial to evaluate the effect of different degree of partial 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 during LSR monitoring under sevoflurane anesthesia. Therefore, the investigators performed a randomized controlled trial to evaluate the effect of different degree of partial 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

入选标准

  • Those who undergo microvascular decompression with sevoflurane anesthesia 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

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)

次要结局

  • 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))
  • 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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeong Jin Lee

Professor

Samsung Medical Center

研究点 (2)

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