NCT07133412尚未招募不适用
An Evaluation of the Neuromuscular Junction in Infants Using Train-of-four Monitoring With the TetraGraph™ Neuromuscular Transmission Monitor
Joseph D. Tobias1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年9月1日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Amplitude
研究概览
简要总结
The goal of this study is to use electromyography-based train-of-four monitoring (TetraGraph™ Neuromuscular Transmission Monitor) as a means of evaluating differences in neuromuscular transmission between infants ≤ 3 months of age and adolescent and older patients (≥ 12 years of age).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 28 Days 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA 1-3 patients
- •Aged 28 days - 3 months or ≥ 12 years
- •Undergoing a surgical procedure with a volatile-agent based anesthetic that does not require administration of a neuromuscular blocking agent
排除标准
- •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 required
- •Edematous patients
- •Patients receiving total intravenous anesthesia (TIVA)
研究组 & 干预措施
Infants
Experimental
Infants 28 days to 3 months old undergoing surgery.
干预措施: TetraGraph (Device)
Adolescents
Active Comparator
Adolescents/young adults 12 years of age or above undergoing surgery.
干预措施: TetraGraph (Device)
结局指标
主要结局
Amplitude
时间窗: First 30 minutes of surgery
Average 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 (1)
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