Evaluation of the New Three-dimensional Acceleromyograph TOF 3D Compared With the Established TOF Watch SX.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- TOF-R 90%
研究概览
简要总结
The TOF 3D is a new acceleromyograph designed to assess the degree of a neuromuscular block during anesthesia. The study compares the new three-dimensional technique with the established TOF Watch SX.
详细描述
The TOF 3D is a new acceleromyograph designed to assess the degree of a neuromuscular block during anesthesia. The study compares the new three-dimensional technique with the established TOF Watch SX. The time course of a neuromuscular block (onset, maximal block, time to recovery) is assessed simultaneously with both devices in 50 patients undergoing elective gynecologic surgery requiring neuromuscular block. The validity and reliability of the new technique is evaluated with a Bland-Altman- analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective gynecologic surgery requiring general anesthesia and neuromuscular block
排除标准
- •anticipated difficult airway
- •Risk of pulmonary aspiration
- •acute infection
- •pregnancy
- •renal or hepatic insufficiency
- •neuromuscular disease
- •chronic intake of drugs influencing neuromuscular block
结局指标
主要结局
TOF-R 90%
时间窗: 12 months
Difference of the 90% train-of-four (TOF) recovery time between both devices
次要结局
- repeatability (precision)(12 months)
- bias and limits of agreement (Bland-Altman analysis)(12 months)
研究者
Stefan Soltesz
Prof. Dr. Stefan Soltesz
Kreiskrankenhaus Dormagen