Observational Project on the Current Neuromuscular Monitoring Practice (Including Extubation Practice) Via TOF-ratio (Train-of-four) Measurements in Different Types of Surgery After Administration of Neuromuscular Blocking Agents With or Without Reversal (Protocol No. P06556)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 659
- 主要终点
- Type of Surgical Procedure Performed in Study Participants
研究概览
简要总结
The intent of this observational study is to collect prospective data regarding neuromuscular monitoring practices and extubation standards (Train-Of-Four [TOF] value) during surgery, in countries of Central and Eastern Europe, Middle East and Africa (CEE/EEMEA countries). Secondarily the study will observe, for which surgical procedures neuromuscular blocking agents (NMBAs), and reversal agents to such, are used. This study is a non-interventional clinical trial, and administration of NMBAs, and respective reversal agents, (as well as all drugs used during anesthesia) will be done in accordance with routine anesthesiology practice, and labeling guidelines. Neuromuscular transmission will be monitored according to routine anesthesiology practice by means of acceleromyography. The assignment of the participant to a particular therapeutic strategy is not decided in advance by a trial protocol, but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Spontaneous NMB reversal
Participants whose reversal from NMB is spontaneous (no reversal agent used)
干预措施: No neuromuscular blockade (NMB)-reversal agent used (Other)
NMB reversal with sugammadex
Participants who are administered sugammadex for NMB reversal in accordance with routine anesthesiology practice, and labeling guidelines
干预措施: Sugammadex (Drug)
NMB reversal with other agents
Participants who are administered any other agent (other than sugammadex) for NMB reversal in accordance with routine anesthesiology practice, and labeling guidelines
干预措施: Other NMB-Reversal Agents Used in Routine Anesthesiology Practice (Drug)
结局指标
主要结局
Type of Surgical Procedure Performed in Study Participants
时间窗: Day of surgery (Day 1)
The type of surgical procedure performed in each study participant was recorded.
Number of Participants With a Train-Of-Four (TOF)-Ratio <0.9 at Extubation
时间窗: At extubation (approximately <1 to 125 minutes after end of surgery)
Neuromuscular function assessment was performed according to routine anesthesiology practice. This typically involves application of repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve and assessment of twitch response at the adductor pollicis muscle. The TOF-ratio, expressed as a decimal from 0.0 up to 1.0, is the ratio of the magnitude of the fourth twitch (T4) to that of the first twitch (T1). The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade. The TOF-ratio was measured at the time of post-surgical extubation. TOF-ratio at time of extubation was to be recorded for each participant, if available, irrespective of the criteria used to make the decision to extubate the participant. TOF-ratio \<0.9 at extubation is considered to indicate a high risk for development of postoperative residual curarization (i.e, residual neuromuscular blockade), which can result in respiratory complications.
Time From End of Surgery (End of Last Stitch) to Extubation
时间窗: From end of surgery (end of last stitch) to extubation (duration of approximately <1 to 62 minutes)
This measure is the duration from the last surgical wound stitch to the post-surgical extubation of the participant. The time of extubation was to be recorded for each participant, irrespective of the criteria used to make the decision to extubate the participant. Data are presented by TOF-ratio \<0.9 and ≥0.9 at extubation. The TOF-ratio is a measure of neuromuscular function ranging from 0.0 to 1.0. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade. TOF-ratio \<0.9 at extubation is considered to indicate a high risk for development of postoperative residual curarization (i.e, residual neuromuscular blockade), which can result in respiratory complications.
Type of NMB-reversal Agent Administered to Study Participants
时间窗: At administration of NMB-reversal agent (up to approximately 395 minutes after start of surgery)
For all participants who received an NMB-reversal agent, the specific agent administered was recorded.
次要结局
- Time From NMB-reversal Agent Administration to Recovery Room Dismissal(Post-surgical and recovery period (up to approximately 170 hours post-surgery))
- Time From NMB-reversal Agent Administration to Operating Room Dismissal(Post-surgical period (up to approximately 24 hours post-surgery))