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

NCT04469881 | Terminated

• 1 other identifier: HM20017126
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

• Sedation requirement

  Micrograms of propofol per kilogram per minute

  approximately 2 hours

Secondary Outcomes (3)

• Participant pain rating

  24 hours

• Opioid consumption

  24 hours

• Time to first opioid request

  up to 24 hours

Study Arms (1)

Virtual Reality

EXPERIMENTAL

Wear VR glasses and watch movies during surgery

Behavioral: VR

Interventions

VR BEHAVIORAL

Participants will be asked to do the following things: 1. Wear VR goggles for the duration of the surgery 2. Answer questions about their experience with the VR goggles 3. Give permission for the researchers to collect information about the anesthesia medications used, pain medications used, and reported pain scores during the surgery and during recovery in the hospital

Virtual Reality

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Study Officials

• Bryant Tran, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 14, 2020
• Study Start: November 24, 2020
• Primary Completion: August 3, 2023
• Study Completion: August 3, 2023
• Last Updated: August 4, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)