Randomized Double---Blinded, Controlled Trial to Compare the Effectiveness of Sugammadex vs. Placebo to Prevent Residual Neuromuscular Block in the Post---Anesthesia Care Unit as Evaluated With a Non---Invasive Respiratory Volume Monitor
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 260
- 试验地点
- 2
- 主要终点
- Decreased Minute Ventilation (MV)
研究概览
简要总结
The study is designed to determine whether patients who receive sugammadex immediately after tracheal extubation will exhibit a decrease in the incidence of postoperative residual paralysis and an associated decrease in the incidence of postoperative respiratory depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing surgery with general anesthesia
- •Patients weighing > or = 80 pounds
- •Patients not intubated prior to surgery
- •Patients who are able to give informed consent
排除标准
- •Patients unable to give informed consent.
- •Patients whose condition will not allow for placement of the electrode PadSet of ExSpiron
- •Patients who are anticipated to remain intubated in recovery period.
研究组 & 干预措施
Sugammadex
Subjects will have Sugammadex administered after routine reversal of anesthesia is performed and patient is extubated.
干预措施: Sugammadex (Drug)
Placebo
Subjects will have Placebo administered after routine reversal of anesthesia is performed and patient is extubated.
干预措施: Placebo (Drug)
结局指标
主要结局
Decreased Minute Ventilation (MV)
时间窗: 15---30 minutes after Post-anesthesia care unit (PACU) arrival
The number of subjects who have a MV as defined as \[MV \<80% MV predicted (MVPRED) based on Body Surface Area\]. MV (or respiratory minute volume or minute volume) is the volume of gas inhaled (inhaled minute volume) or exhaled (exhaled minute volume) from a person's lungs per minute.
Decreased Average Minute Ventilation (MV)
时间窗: 15---30 minutes after Post-anesthesia care unit (PACU) arrival
The number of subjects who have an average MV \<80% MV predicted (MVPRED) based on Body Surface Area. MV (or respiratory minute volume or minute volume) is the volume of gas inhaled (inhaled minute volume) or exhaled (exhaled minute volume) from a person's lungs per minute.
次要结局
- Train of Four (TOF) Ratio(upon PACU discharge, approximately 8 hours)
研究者
J. Ross Renew, M.D.
Principal Investigator
Mayo Clinic