NCT06458023已完成不适用
Train-of-four Monitoring Using the Tetragraph Neuromuscular Transmission Monitor and Comparison to Standard (Visual) Train-of-four Assessment With a Peripheral Nerve Stimulator in Patients Less Than 1 Year of Age.
Joseph D. Tobias2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年6月11日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- EMG changes
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of train-of-four (TOF) monitoring using the TetraGraph Neuromuscular Transmission Monitor in pediatric patients less than 1 year of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≤ 1 year of age
- •undergoing a surgical procedure with general anesthesia and requiring the administration of an NMBA
排除标准
- •Patients less than 28 days old
- •Patients with history of a peripheral neurologic or neuropathic disorder
- •Patients in whom the upper extremity cannot be used for TOF monitoring
- •Patients undergoing a surgical procedure in which neuromuscular blockade is not required
- •Edematous patients
研究组 & 干预措施
TetraGraph (TM) NMT Monitor
Experimental
TetraGraph is a unique, EMG-based portable device for quantitative (objective) monitoring of neuromuscular function. It is a precise and easy to use tool for monitoring depth of block, ensuring adequate recovery of muscle function, and aiding the clinician to reduce the incidence of residual block.
干预措施: TetraGraph (TM) NMT Monitor (Device)
结局指标
主要结局
EMG changes
时间窗: During the surgery
Changes in the amplitude of the evoked response of the muscles.
次要结局
未报告次要终点
研究者
Joseph D. Tobias
Chief, Dept. of Anesthesiology & Pain Medicine
Nationwide Children's Hospital
研究点 (2)
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