跳至主要内容
临床试验/NCT04469881
NCT04469881终止不适用

Netflix Streaming Services in the Operating Room During Total Knee Replacement - a Feasibility Study

Virginia Commonwealth University2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2020年11月24日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
3
试验地点
2
主要终点
Sedation requirement

研究概览

简要总结

The purpose of this research study is to test the safety, tolerability, and effectiveness of watching streamed videos through virtual reality (VR) goggles during surgery.

The results of this study will be used to evaluate whether video-streaming services on VR goggles are worthwhile additions to standard anesthesia care during total knee surgery.

详细描述

Usual anesthetic care for total knee replacement involves intravenous sedation as well as spinal anesthesia. In this study, participants will receive usual care, and in addition, will be asked to wear VR goggles once they arrive in the operating room. Participants will choose from a selection of 10 shows and movies to watch for the duration of the surgery (approximately 2 hours).

研究设计

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

  • undergoing a primary elective total knee replacement by one of the orthopedic joint surgeons at Virginia Commonwealth University Medical Center
  • 18 years of age or older
  • eligible for spinal anesthesia
  • mentally capable of understanding instructions on how to request anesthesia medication

排除标准

  • identified as a member of regulated vulnerable population
  • ineligibility for spinal anesthesia
  • morbid obesity (body mass index greater than 40)
  • allergy to propofol or midazolam
  • pre-operative daily opioid consumption of more than 10 mg oxycodone every 6 hours (over 60 morphine miligram equivalents per day)
  • daily benzodiazepine consumption
  • history of alcohol or recreational drug abuse
  • hearing or visually impaired individuals

结局指标

主要结局

Sedation requirement

时间窗: approximately 2 hours

Micrograms of propofol per kilogram per minute

次要结局

  • Time to first opioid request(up to 24 hours)
  • Participant pain rating(24 hours)
  • Opioid consumption(24 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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