跳至主要内容
临床试验/NCT07435792
NCT07435792Enrolling By Invitation不适用

Train-of-four Monitoring Using the TetraGraph Electromyographic Neuromuscular Transmission Monitor to Evaluate Onset and Recovery Times of a Single Bolus Dose of Rocuronium

Nationwide Children's Hospital1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2026年8月25日最近更新:
适应症
干预措施

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

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joseph D. Tobias

Chief - Department of Anesthesiology & Pain Medicine

Nationwide Children's Hospital

研究点 (1)

Loading locations...

相似试验