Feasibility of Neostigmine as a Reversal Agent of Neuromuscular Blockade for Intraoperative Neuromonitoring During Thyroid Surgery: a Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Time to recovery of cricothyroid muscle twitching
研究概览
简要总结
For successful intraoperative neuromonitoring (IONM), adequate reversal of neuromuscular blocking agent is a prerequisite in thyroid surgery with .
The aim of this study is to investigate the feasibility of neostigmine just after tracheal intubation on the IONM in thyroid surgery.
详细描述
For successful intraoperative neuromonitoring (IONM), adequate reversal of neuromuscular blocking agent is a prerequisite in thyroid surgery with .
The aim of this study is to investigate the feasibility of neostigmine just after tracheal intubation on the IONM in thyroid surgery.
This study will be performed as a randomized controlled trial with two groups (N group: neostigmine group and NS group: normal saline group).
For the N group, neostigmine (0.03 mcg / kg) and glycopyrrolate with a 5:1 ratio will be administered just after tracheal intubation.
For the NS group, normal saline with a same volume of the N group will be administered just after tracheal intubation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
For participant, they will be blind to the group which they will be assigned. The surgeon, who will evaluate the quality of the signal, will be blinded to patient's group.
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •open thyroid surgery with intraoperative neuromonitoring
排除标准
- •refusal to participate in the study
- •rocuronium should not be used (e.g. renal dysfunction patient)
研究组 & 干预措施
Neostigmine
For the Neostigmine (N) group, neostigmine (0.03 mcg / kg) and glycopyrrolate with a 5:1 ratio will be administered just after tracheal intubation.
Investigators evaluate the quality of signal of IONM during the surgery.
干预措施: Neostigmine (Drug)
Normal saline
For the Normal saline (NS) group, normal saline with a same volume of the N group will be administered just after tracheal intubation.
Investigators evaluate the quality of signal of IONM during the surgery.
干预措施: Normal saline (Drug)
结局指标
主要结局
Time to recovery of cricothyroid muscle twitching
时间窗: perioperative
Time from the rocuronium administration to recovery of cricothyroid muscle twitching
次要结局
- amplitude of EMG for V2(During surgery)
- amplitude of EMG for R1(During surgery)
- amplitude of EMG for V1(During surgery)
- amplitude of EMG for R2(During surgery)
- number of patients with involuntary movements disrupting surgery(During surgery)
研究者
Jung-Man Lee
Associate professor
Seoul National University Hospital