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临床试验/NCT02930629
NCT02930629Unknown不适用

Assessment of Residual Paralysis in Patients in the Postoperative Anaesthetic Care Unit (PACU)

Singapore General Hospital1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2016年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
400
试验地点
1
主要终点
Evidence of residual block (train of four <0.9) after receiving neuromuscular block for anaesthesia for surgery

研究概览

简要总结

The purpose of this study is to assess the incidence of residual block in patients arriving in the Post Anaesthetic Care Unit (PACU) following surgery, and in those who have received neuromuscular blocking drugs (muscle relaxants). Residual block (decreased motor function) due to residual levels of muscle relaxants is associated with increased morbidity.

详细描述

This is a prospective, cross sectional study. Adult patients undergoing surgery in the main operating theatres of Singapore General Hospital and requiring general anaesthesia and muscle relaxants will be enrolled and assessed over a 4 month period.

Explanation, handing over of the Participation Information Sheet, and consent taking for the research will be taken either: In the anaesthetic Pre-operative Evaluation Clinic (PEC) which takes place on average 1-2 weeks prior to surgery itself; or On the ward, as a portion of patients are admitted as an inpatient the day before surgery. This allows patients time to consider participation into the study.

The conduct of anaesthesia before arrival in PACU is left to the discretion of the attending anaesthetist. After arrival in PACU, patients are cared for by the PACU nurse and attending anaesthetist. The PI or co-investigators of the participants will follow up patients arriving in PACU if they fit the inclusion criteria i.e. who have received muscle relaxants during their anaesthetic.

Participants will have their neuromuscular function monitored using a TOF Watch. This is a neuromuscular monitor used to assess the twitch height of muscles when stimulated by small electrical currents. Assessing neuromuscular function at all stages of anaesthesia (during anaesthesia and during recovery from anaesthesia) is the standard of care and is considered "essential" as per guidelines from the Association of Anaesthetists of Great Britain and Ireland (2015).

The following are standards of care in PACU if patients are suspected of having residual block:

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
21 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients 21 years old or older, who receive neuromuscular blocking drugs (muscle relaxants) as part of their anaesthesia for surgery.

排除标准

  • Patients who have neuromuscular disease
  • Patients for whom applying train-of-four (to detect residual block) monitoring on their ulnar nerves is not possible

结局指标

主要结局

Evidence of residual block (train of four <0.9) after receiving neuromuscular block for anaesthesia for surgery

时间窗: Within one hour of surgery

Train of four is measured at the adductor pollicis using TOF Watch acceleromyography

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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