Train-of-four Monitoring Using the TetraGraph Electromyographic Neuromuscular Transmission Monitor to Evaluate Onset and Recovery Times of a Single Bolus Dose of Rocuronium
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Onset time
研究概览
简要总结
In most clinical instances, direct laryngoscopy and endotracheal intubation is performed after a set time (generally 60 seconds) following the administration of a neuromuscular (NM) blocking agent, rocuronium. Although the average onset time is 60 seconds, clinical studies show a standard deviation around the mean onset time of 10-20 seconds, meaning that a significant number of patients do not achieve complete NM blockade by 60 seconds. Given the above noted variability, complete NM blockade may not be achieved in 60 seconds in a significant percentage of patients, resulting in more problematic direct laryngoscopy and endotracheal intubation. Various studies have shown a higher incidence of perioperative respiratory events and postoperative concerns (sore throat, vocal cord injury) when NM blockade is not complete prior to endotracheal intubation.
This study aims to use the TetraGraph monitor to clearly identify onset times of rocuronium. Additionally, whenever feasible based on the clinical needs of the case, recovery times after the single dose of rocuronium will be recorded.
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 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •consenting American Society of Anesthesiologists (ASA) Physical Status 1-4 patients
- •undergoing a surgical procedure with general anesthesia and requiring the administration of rocuronium
排除标准
- •Patients with history of a progressive or degenerative peripheral neurologic or neuropathic disorder
- •Patients undergoing a surgical procedure in which neuromuscular blockade is not required
- •Edematous patients
研究组 & 干预措施
Neuromuscular blockade
Patients receiving a neuromuscular blockade with rocuronium 0.6 mg/kg.
干预措施: TetraGraph (Device)
结局指标
主要结局
Onset time
时间窗: Baseline
Amount of time from administration of rocuronium to the monitor reading 0 twitches.
次要结局
- Recovery time(At the completion of surgery)
研究者
Joseph D. Tobias
Chief - Department of Anesthesiology & Pain Medicine
Nationwide Children's Hospital
