跳至主要内容
临床试验/NCT01181349
NCT01181349已完成不适用

Incidence of Postoperative Residual Neuromuscular Blockade - A Multicenter, Observational Study in Portugal

Merck Sharp & Dohme LLC0 个研究点目标入组 350 人开始时间: 2010年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
350
主要终点
Number of Participants With Train-of-four (TOF) Ratio <0.9 at PACU Arrival

研究概览

简要总结

This is a multicenter, observational study in adult participants undergoing different types of elective surgical procedures requiring general anesthesia. During the first study period, there will be a cross-sectional evaluation of neuromuscular blockade level upon participant arrival at Post Anesthesia Care Units (PACUs). During the second study period, hospital discharge data from the participants will be collected. The purpose of this study is to determine the incidence of incomplete postoperative neuromuscular recovery from anesthesia at PACUs in Portuguese hospitals. This is a cross-sectional and retrospective study.

研究设计

研究类型
Observational
观察模型
Cohort

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years of age or older
  • Informed consent signed
  • Admission for elective surgery
  • Administration of nondepolarizing NMBAs during surgery

排除标准

  • Admission for emergency surgery
  • Reoperation on the same hospital admission

结局指标

主要结局

Number of Participants With Train-of-four (TOF) Ratio <0.9 at PACU Arrival

时间窗: Upon arrival in the PACU

The incidence of incomplete postoperative neuromuscular recovery from general anesthesia was assessed in study participants upon arrival in the PACU, after their respective surgical procedures were completed. Neuromuscular functioning was assessed by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. The TOF ratio is the ratio of the magnitude of the fourth twitch to that of the first twitch, and a ratio \<0.9 indicates residual neuromuscular blockade (incomplete neuromuscular recovery).

次要结局

  • Number of Participants With and Without Postoperative Residual Neuromuscular Blockade With Postoperative Events(From end of surgery through hospital discharge, an expected average of 6 days)
  • Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Identified Neuromuscular Blocking Agents(From start of surgery through PACU arrival)
  • Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Neuromuscular Blockade Reversal Agents(From end of surgery through PACU arrival, an expected average of 10 minutes)
  • Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Propofol or Sevoflurane(From start of surgery through PACU arrival)

研究者

申办方类型
Industry
责任方
Sponsor

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