Best Management of Muscle Relaxation With Rocuronium Using Objective Monitoring and Reversal With Neostigmine or Sugammadex
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Incidence of Postoperative Residual Neuromuscular Blockade at Time of Extubation
研究概览
简要总结
The purpose of this study is to demonstrate that the investigators can reduce residual paralysis to a very low incidence, and that the investigators can do this while preserving a role for the older and less expensive reversal agent neostigmine. The investigators consider this an evidence-based approach because previous reports clearly indicate that neostigmine is effective for reversal of the most shallow neuromuscular blocks, a level of block now referred to as minimal block. The Investigators also know from previous data that a substantial proportion of patients have minimal block. Sugammadex will be used when the block to be reversed is deeper than minimal, specifically when the objectively measured TOF-ratio is <40%.
The investigators hypothesize that this protocol will be associated with an incidence of residual paralysis of less than 3%. The investigators plan is to study 200 patients.
详细描述
This study implements a standardized protocol for NMBD (neuromuscular blocking drug) management that is currently used by some providers at UWMC and HMC to help prevent residual paralysis in surgical patients. While this protocol is within the scope of routine care that an anesthesiologist could follow in his/her clinical practice, it is not consistently used throughout HMC and UWMC. This protocol follows clinical best practices for NMBD management in a surgical population and adheres to the recommendations from the P&T committee on reversal drug choice and recommendations from the Department of Anesthesiology and Pain Medicine on neostigmine dosing. While this protocol is in line with best practices, the investigators are continuing to systematically evaluate it in the setting of prospective research. All drugs will be administered for clinical care only. This research does not add additional medications. The study will take place at UWMC and HMC and will follow a standardized research protocol for the timing, dosing, and monitoring surrounding muscle relaxants and reversal, and makes use of objective TOF monitors. If a patient agrees to participate in this study, the following research protocol will occur:
Before Surgery:
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TOF measurements before surgery: A study investigator will perform the routine clinical train-of-four measurements with an objective monitor at baseline after the clinical induction of general anesthesia but before the administration of the NMBD. Information will be recorded for research purposes. Research staff will leave the operating room after obtaining the baseline measurement and will return to the operating room at the end of the surgical procedure, to be available for TOF ratio measurements at the time that reversal of paralysis is planned as well as for the primary outcome measurement, i.e. at time of extubation.
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Dose calculation of initial NMBD: A study investigator will assist the anesthesia provider with calculation of the recommended intubating dose of rocuronium (an NMBD). The dose will be calculated per this research protocol based on Ideal Body Weight (IBW).
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For women 45.5 kg plus 2.3 kg/inch over 5 feet of height
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For men 50 kg plus 2.3 kg/inch over 5 feet of height.
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For routine intubations, the recommended dose for intubation will be a maximum of Rocuronium 0.6 mg/kg.
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The intubating dose will be reduced by 15% for females.
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Higher intubating dose may be used at the discretion of the anesthesia provider
During Surgery:
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
- 否
入选标准
- •Are 18 years or older
- •Undergoing surgery expected to last less than 6 hours at HMC or UWMC
- •Have ASA physical status I-III
- •Scheduled to have general anesthesia with at least 1 dose of nondepolarizing NMBD for endotracheal intubation or intraoperative neuromuscular block (NMB)
排除标准
- •Allergy to NMBDs, neostigmine, or sugammadex
- •Patients with neuromuscular disease (myasthenia gravis or muscular dystrophy)
- •Pregnant or lactating women
- •Non English speaking
- •Unable to provide informed consent
- •Severe renal failure with eGFR less than 20 ml/min
结局指标
主要结局
Incidence of Postoperative Residual Neuromuscular Blockade at Time of Extubation
时间窗: Within two minutes of extubation
Train-of-four ratio \<0.9 as measured by electromyography or \<1.0 measured by acceleromyography
次要结局
- Incidence of Severe Postoperative Residual Neuromuscular Blockade at Time of Extubation(Within two minutes of extubation)
研究者
Stephan Thilen
Assistant Professor, School of Medicine: Anesthesiology & Pain Medicine
University of Washington