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临床试验/NCT03543826
NCT03543826已完成4 期

Best Practice With Rocuronium, Neostigmine, Sugammadex, and Subjective Monitoring.

University of Washington2 个研究点 分布在 1 个国家目标入组 201 人开始时间: 2018年5月21日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
201
试验地点
2
主要终点
Incidence of Postoperative Residual Neuromuscular Blockade at Time of Arrival to the Post-anesthesia Care Unit.

研究概览

简要总结

This is an estimation study, prospectively evaluating the incidence of postoperative residual neuromuscular blockade (PRNB) when a best practice protocol is implemented for a cohort of abdominal surgery and orthopedic surgery patients. The protocol is developed within the constraint of subjective monitoring, quantitative monitoring is not used, and use of rocuronium for paralysis and either neostigmine or sugammadex for reversal. The primary outcome is the incidence of PRNB on arrival to the post-anesthesia care unit, defined as a train-of-four ration <0.9.

详细描述

This study estimates the incidence of postoperative residual neuromuscular block when rocuronium neuromuscular block is managed by protocol for qualitative monitoring and reversal with neostigmine or sugammadex. The study is an extension of the recently published study by Thilen and co-workers which evaluated a protocol which used neostigmine as the sole reversal agent (doi: 10.1016/j.bja.2018.03.029). It demonstrated that use of a protocol was associated with a reduced incidence of severe residual paralysis, defined as normalized train-of-four (TOF) ratio <0.7 at time of tracheal extubation. It was also associated with a highly significant reduction in PRNB as defined for several secondary outcomes, including non-normalized (i.e. raw) TOF-ratio <0.9 at time of arrival to the post-anesthesia care unit (PACU).

The current study does not include a control group, only an intervention group. The investigators hypothesize that PRNB can be prevented by adhering to a protocol which incorporates several current recommendations by experts. Importantly, the protocol preserves a role for neostigmine when the pre-reversal assessment indicates that spontaneous recovery has progressed to a so-called minimal block which is defined as the subjective absence of fade in the adductor pollicis TOF response. The investigators will study only abdominal surgery and orthopedic surgery patients. The primary outcome is incidence of PRNB, defined as TOF-ratio <0.9 on arrival to the PACU. The investigators plan to enroll 120 patients, and if no more than one patient has PRNB, the upper bound for the 95% confidence interval will be less than 5%.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
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

入选标准

  • Adult 18 years old or older, Will undergo open or laparoscopic abdominal surgery or orthopedic surgery expected to last <6 hours at Harborview or Univ of Wash Med Ctr, Have American Society of Anesthesiologists physical status I-III, scheduled to have general anesthesia with at least 1 dose of nondepolarizing neuromuscular blocking drug for endotracheal intubation or intraoperative neuromuscular blockade.

排除标准

  • Allergy to neuromuscular blocking drugs, patients with neuromuscular disease (myasthenia gravis or muscular dystrophy), pregnant or lactating women, non-English speaking.

结局指标

主要结局

Incidence of Postoperative Residual Neuromuscular Blockade at Time of Arrival to the Post-anesthesia Care Unit.

时间窗: Within five minutes of arrival to the post-anesthesia care unit.

Postoperative residual neuromuscular blockade is measured by a Train-of-four ratio \<0.9 as measured by acceleromyography.

次要结局

  • Incidence of Postoperative Severe Residual Neuromuscular Blockade at Time of Tracheal Extubation(Within two minutes of time of extubation.)
  • Incidence of Postoperative Severe Residual Neuromuscular Blockade at Time of Arrival to the Post-anesthesia Care Unit.(Within five minutes of arrival to the post-anesthesia care unit.)
  • Incidence of Postoperative Residual Neuromuscular Blockade at Time of Tracheal Extubation.(Within two minutes of time of extubation.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephan Thilen

Associate Professor

University of Washington

研究点 (2)

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