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临床试验/NCT03614325
NCT03614325已完成不适用

Virtual Reality in the Operating Room: Using Immersive Relaxation as an Adjunct to Anesthesia

Beth Israel Deaconess Medical Center2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年12月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Intraoperative Propofol Dose

研究概览

简要总结

This is a randomized, controlled trial designed to investigate whether the use of virtual reality immersive relaxation during hand/arm operations can allow for a relaxing operating room experience for patients while potentially reducing anesthesia requirements.

详细描述

The proposed study is a randomized, controlled trial to evaluate the effectiveness of VR as an adjunct to standard anesthetic practice for upper extremity surgery. Patients will be randomized to undergo immersion relaxation via the use of VR during their procedure or control. In both groups patients will undergo regional anesthesia preoperatively according to standard practice. Patients will then be assessed postoperatively to assess the intraoperative propofol dose between groups, as well as secondary outcomes including patient satisfaction.

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
Single (Outcomes Assessor)

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

  • Patients undergoing upper extremity (hand, wrist, arm, and/or elbow) surgery at BIDMC under MAC

排除标准

  • Age < 18
  • Open wounds or active infection of the face or eye area
  • History of seizures or other symptom linked to an epileptic condition
  • Patients who plan to wear hearing aids during the procedure
  • Patients with a pacemaker or other implanted medical device
  • Droplet or airborne precautions (as determined by BIDMC infection control policy)
  • Non-English speaking
  • Patients who require deep sedation
  • Patients who are deemed ineligible to approach by the surgeon

结局指标

主要结局

Intraoperative Propofol Dose

时间窗: 60 minutes

Total propofol dose (mg/kg/min) administered intraoperatively will be measured for the duration of the procedure.

次要结局

  • Other Intraoperative Anesthetics or Analgesics Administered(60 minutes)
  • Length of PACU Stay(Duration of the patient's stay in the post anesthesia care unit, 100 minutes)
  • Total Intraoperative Propofol Administered(60 minutes)
  • Patient Survey: Agreement With the Following Statements (0-100)(PACU discharge)
  • Difference Between Preoperative and Postoperative QuickDASH Scores(One month postoperatively)
  • Pain Assessed by Eleven Point Numerical Rating Scale(Duration of stay in the post anesthesia care unit, 100 minutes)
  • Overall Patient Satisfaction(PACU discharge)
  • Hand Disability (QuickDASH)(One month postoperatively)

研究者

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

Brian O'Gara

Attending Anesthesiologist, Principal Investigator

Beth Israel Deaconess Medical Center

研究点 (2)

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