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Clinical Trials/NCT03614325
NCT03614325
Completed
N/A

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

Beth Israel Deaconess Medical Center1 site in 1 country40 target enrollmentDecember 4, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Anesthesia, Intravenous
Sponsor
Beth Israel Deaconess Medical Center
Enrollment
40
Locations
1
Primary Endpoint
Intraoperative Propofol Dose
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
December 4, 2018
End Date
June 1, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Brian O'Gara

Attending Anesthesiologist, Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Intraoperative Propofol Dose

Time Frame: 60 minutes

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

Secondary Outcomes

  • 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)

Study Sites (1)

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