Minimal Sedation During Total Knee Arthroplasty: A Prospective Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Mean Richmond Agitation-Sedation Scale(RASS) Score
研究概览
简要总结
This study will test the use of active noise cancelling headphones with music or a movie during knee replacement surgery. Feedback from the surgical team and from patients regarding the headset system will be gathered to see if using it can reduce the amount of sedation needed during knee replacement procedures that use localized anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Primary Total Knee Arthroplasty
- •Indicated for Spinal Anesthesia
- •18+ years old
- •Participant can independently provide informed consent
排除标准
- •Unicompartmental Knee Arthroplasty
- •Revision Knee Arthroplasty
研究组 & 干预措施
Active Noise Cancelling Headset
This arm will provide patients with an active noise cancelling headset system that they may use to select music or a movie for audiovisual distraction during the surgery.
干预措施: Active Noise Cancelling Headset System (Device)
No active noise cancelling headset
This arm will serve as the control group for this randomized trial. Patients in this arm will receive normal standard of care anesthesia during their total knee arthroplasty.
结局指标
主要结局
Mean Richmond Agitation-Sedation Scale(RASS) Score
时间窗: 30 minutes intraoperatively
Richmond Agitation-Sedation Scale (RASS) measures the amount of sedation necessary for a patient at different levels of discomfort or agitation during local anesthesia surgeries.
Protocol Completion
时间窗: Intraoperatively
This will measure the volume of patients that were unable to complete their procedure using spinal anesthesia and due to discomfort or agitation required deep sedation to continue to surgery.
Mean Propofol Infusion Rate
时间窗: Intraoperatively
Mean rate of propofol infusion necessary to achieve sedation targets during the procedure. Unit: mcg/kg/min
次要结局
- Patient Satisfaction(Within 48 hours post-operatively)
- Surgeon Satisfaction(Within 48 hours post-operatively)
- Anesthetist Satisfaction(Within 48 hours post-operatively)
研究者
Matthew P. Abdel, M.D.
Professor of Orthopedics
Mayo Clinic