Intraoperative Virtual Reality for Older Patients Undergoing Total Knee Arthroplasty
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Total Knee Arthroplasty
- Sponsor
- Beth Israel Deaconess Medical Center
- Enrollment
- 131
- Locations
- 1
- Primary Endpoint
- Intraoperative Propofol Dose
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
Brief Summary
The objective of this study is to investigate whether the use of virtual reality (VR) during total knee arthroplasty (TKA) can facilitate reductions in intraoperative sedative requirements while maintaining high levels of patient satisfaction as compared to both a music and sham VR + usual care control.
Detailed Description
The investigators will conduct a three-armed randomized controlled trial with the following aims: Specific Aim 1: Evaluate whether the use of VR during TKA can facilitate a reduction in intraoperative propofol dose required for patient comfort as compared to music and sham VR + usual care controls. Hypotheses: Patients in both the VR and music groups will demonstrate reductions in propofol dose compared to sham VR + usual care controls. A reduction in propofol dose between the VR and music group will be smaller in magnitude. Specific Aim 2: Assess the effect of VR during TKA on patient reported outcomes including overall satisfaction, pain, and anxiety as compared to music and sham VR + usual care controls. Hypotheses: Patients in the VR group will report significantly higher satisfaction and better control of pain and anxiety than those in the music group and usual care group. Specific Aim 3: Explore the potential effects of VR during TKA on other key secondary outcomes of perioperative efficiency, postoperative cognition, and functional recovery. Hypotheses: Patients in the VR group will have shorter post-anaesthesia care unit (PACU) length of stay as compared to sham VR + usual care controls. The effect of VR on postoperative delirium, postoperative cognitive decline, postoperative opioid use and functional recovery will be exploratory endpoints.
Investigators
Brian O'Gara
Assistant Professor of Anaesthesia
Beth Israel Deaconess Medical Center
Eligibility Criteria
Inclusion Criteria
- •Patients age 60 or older undergoing primary total knee replacement surgery at BIDMC and receiving spinal/regional anesthesia
- •English or Spanish speaking patients
Exclusion Criteria
- •Complex or revision surgeries
- •Patients scheduled for "same day" TKA
- •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 local infection control policy)
- •Non-English speaking or Non-Spanish speaking
- •Moderate to severe dementia
- •Drop-Out Criteria:
Outcomes
Primary Outcomes
Intraoperative Propofol Dose
Time Frame: Duration of the procedure, on average 1 to 3 hours
Total propofol dose (mg/kg/min) administered intraoperatively
Secondary Outcomes
- Intraoperative Anesthesia Maneuvers(Duration of the procedure, on average 1 to 3 hours)
- Postoperative Pain(Measured on postoperative day zero and one, starting with PACU scores)
- Satisfaction with Anesthesia(Within an hour of admission to the postoperative anesthesia care unit)
- Assessment of Knee Pain and Function(Assessments will take place within 7 days of the initial clinic visit and within 7 days of the initial postoperative clinic visit, typically one month after surgery.)
- Length of PACU stay(Duration of the patient's stay in the post anesthesia care unit, on average 1 to 5 hours)
- Delayed Cognitive Recovery and Postoperative Neurocognitive Disorder(Assessment will take place on day of enrollment and then at one week (+/- 48 hours) and one month postoperatively (+/- 7 days).)
- Intraoperative and Postoperative Opioids(Duration of the procedure, on average 1 to 3 hours, and up until 72-hours postoperatively)
- Satisfaction with Recovery(Postoperative day one)
- Postoperative Delirium(Measured daily on each postoperative day, starting on postoperative day 1 until postoperative day 7.)