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

Not Applicable

Terminated

• Conditions: Surgery
• Interventions: Behavioral: VR

• Registration Number: NCT04469881
• Lead Sponsor: Virginia Commonwealth University

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.

Detailed Description

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).

Study Timeline

• Study First Submitted: 2020-07-09
• Study First Submitted QC: 2020-07-09
• Study First Posted: 2020-07-14
• Study Start: 2020-11-24
• Status Verified: 2023-08
• Primary Completion: 2023-08-03
• Study Completion: 2023-08-03
• Last Update Submitted: 2023-08-03
• Last Update Posted: 2023-08-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

1. undergoing a primary elective total knee replacement by one of the orthopedic joint surgeons at Virginia Commonwealth University Medical Center
2. 18 years of age or older
3. eligible for spinal anesthesia
4. mentally capable of understanding instructions on how to request anesthesia medication

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Virtual Reality	VR	Wear VR glasses and watch movies during surgery

Primary Outcome Measures

Name	Time	Method
Sedation requirement	approximately 2 hours	Micrograms of propofol per kilogram per minute

Secondary Outcome Measures

Name	Time	Method
Time to first opioid request	up to 24 hours	Time in minutes between leaving the operating room and administration of first oral opioid.
Participant pain rating	24 hours	Average pain score measured immediately after surgery and every 4 hours afterwards for 24 hour. Pain will be rated on a 0 to 10 scale with 0 being no pain and 10 being the worst pain imaginable.
Opioid consumption	24 hours	Total miligram morphine equivalents of opioid pain medication administered during 24 hours post surgery.

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States