Residual Curarization and Its Incidence at Tracheal Extubation in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,571
- 试验地点
- 32
- 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 a prospective, multi-site, anesthesiologist and PACU nurse TOF-Watch SX® blinded observational study of surgical patients undergoing elective laparoscopic or open abdominal procedures requiring general anesthesia and non-depolarizing neuromuscular blockade. There are two temporal aspects to the data collection: a prospective data collection in the OR and PACU; and a retrospective chart review one week after hospital discharge.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •American Society of Anesthesiologists(ASA) class 1-3;
- •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;
- •Planned for extubation to occur in the OR;
- •Signed informed consent.
排除标准
- •Redo surgery on the same hospital admission;
- •Pre-established need or expected to require post-operative mechanical ventilation;
- •Conditions, surgical procedures, or participant positioning that may interfere with TOF-Watch SX® operation, calibration, or accuracy;
- •Anesthesiologist use of objective neuromuscular monitoring during surgery (e.g. mechanomyography, electromyography or related method);
- •Pregnancy;
- •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.
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: Immediately prior to tracheal extubation in the OR
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 pollices 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 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(Immediately upon 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(Immediately prior to tracheal extubation in the OR)
- Percentage of Participants With Residual NMB (TOF Ratio <0.9) Upon Arrival to the Post-anesthesia Care Unit (PACU)(Immediately upon PACU arrival)
研究者
Xinmin Wu
Professor
Peking University First Hospital