Residual Curarization and Its Incidence at Tracheal Extubation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 302
- 主要终点
- Percentage of Participants With Residual Neuromuscular Blockade (NMB)(Train of Four [TOF] Ratio <0.9) at Time of Tracheal Extubation
研究概览
简要总结
This study will assess the residual neuromuscular blockade (NMB) Train-Of-Four (TOF) ratios at tracheal extubation when anesthesiologists have determined that full recovery of neuromuscular function has occurred using standard clinical criteria for participants whose non-depolarizing-induced NMB is either not reversed or reversed with an acetylcholinesterase inhibitor administered as per standard routine care.
详细描述
This is an observational cohort study with a device intervention to determine in which cohort the subject is falling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be American Society of Anesthesia (ASA) class 1-
- •Participant must be scheduled for elective open or laparoscopic abdominal surgery that is anticipated to last less than 4 hours.
- •Administration of general anesthesia and ≥ 1 dose of non-depolarizing neuromuscular blockers for endotracheal intubation or maintenance of neuromuscular blockade.
- •Extubation must occur in the operating room (OR).
排除标准
- •Surgery re-admission on the same hospital admission.
- •Pre-established need for or expected to require post-operative mechanical ventilation.
- •Conditions, surgical procedures or position that may interfere with the TOF-Watch SX® operation, calibration or accuracy.
- •Administration of sugammadex (Bridion®) for reversal of neuromuscular blockade.
- •Participation in any other clinical trial.
- •Member or a family member of the personnel of the investigational or Sponsor staff directly involved with this trial.
- •Anesthesiologist use of objective neuromuscular monitoring during surgery (e.g. mechanomyography, electromyography or related method).
结局指标
主要结局
Percentage of Participants With Residual Neuromuscular Blockade (NMB)(Train of Four [TOF] Ratio <0.9) at Time of Tracheal Extubation
时间窗: Up to 1 minute prior to tracheal extubation
Neuromuscular functioning was monitored at time of tracheal extubation by applying three TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB. A T4/T1 Ratio of \<0.9 is indicative of residual NMB.
次要结局
- Percentage of Participants With Residual NMB (TOF Ratio <0.9) Upon Arrival to the Post-anesthesia Care Unit (PACU)(Up to 2 minutes prior to PACU arrival)
- Percentage of Participants With Residual NMB at Various TOF Ratios (<0.6, ≥0.6 to <0.7, ≥0.7 to <0.8, ≥0.8 to <0.9) at Tracheal Extubation(Up to 1 minute prior to tracheal extubation)
- Percentage of Participants With Residual NMB at Various TOF Ratios (<0.6, ≥ 0.6 to <0.7, ≥ 0.7 to <0.8, ≥0.8 to <0.9) Upon Arrival to the PACU(Up to 2 minutes prior to PACU arrival)