Virtual Reality for Anxiolysis and Pharmacological Sparing
NCT Number: NCT06522711
Acronym: V-RAPS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Virtual Reality|Propofol
Interventions: DEVICE: Virtual reality headset|OTHER: Standard of care
Sponsor: Ciusss de L'Est de l'Île de Montréal
Collaborators: Paperplane Therapeutics
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-01
Completion Date: 2026-09-01
Locations: Maisonneuve-Rosemont Hospital - CIUSSS de l'Est de l'Île de Montréal, Montréal-Est, Quebec, H1T2M4, Canada

Summary:
The goal of this clinical trial is to learn if virtual reality can reduce propofol requirements in adult, female patients undergoing elective breast surgery under regional anesthesia. The main question it aims to answer is:

Can virtual reality immersion reduce intra-operative propofol requirements in adult female patients undergoing elective breast surgery under regional anesthesia?

Researchers will compare time and weight-adjusted average propofol requirements in both the intervention group and the control group to see if there is a reduction in sedative usage in the group using the virtual reality device.

Participants will be randomly assigned to either a virtual reality (intervention) group or a control group.

* The patients in the virtual reality group will have a virtual reality headset on during the surgery with a preselected scenario of their choice.
* Both groups will have access to patient-controlled sedation under the supervision of an anesthesiologist and will be permitted to self-administer propofol boluses as needed.

Primary Outcome Measures: Propofol self-administration, Time-adjusted and weight-adjusted average self-administration of propofol in mcg/kg/min in female patients undergoing breast surgery under paravertebral block., Between 1 hour and 3 hours
Secondary Outcome Measures: Preoperative anxiety, Level of anxiety before the surgery evaluated by the Amsterdam Preoperative Anxiety and Information Scale., Up to 1 hour|Remifentanil administration, Time-adjusted and weight-adjusted average administration of remifentanil in mcg/kg/min., Between 1 hour and 3 hours|Ketamine administration, Weight-adjusted administration of ketamine in mg/kg., Between 1 hour and 3 hours|Adverse events, The incidence of adverse events such as cybersickness, nausea, bradycardia, desaturation and hypotension., Between 1 hour and 3 hours|Scenario switches, Percentage of patients that switched scenarios., Between 1 hour and 3 hours|Virtual reality usage, The total time, in minutes, as well as the relative time compared to the duration of the surgery, expressed as a percentage, during which the VR headset was worn., Between 1 hour and 3 hours|Virtual reality usage per first scenario, Total duration in minutes spent by the patient on the VR scenario chosen, and the order in which VR scenarios were presented., Between 1 hour and 3 hours|Virtual reality headset removal, Percentage of patients that removed the headset before the end of the surgery., Between 1 hour and 3 hours|Post-Anesthesia Care Unit stay, The total time in minutes spent in the PACU., Between 30 minutes and 2 hours|Enthusiasm at the idea of using virtual reality, Initial enthusiasm at the idea of using a VR headset during surgery assessed on a 10 point Likert scale., Up to 1 hour|Ease of use, Ease of use of the virtual reality technology assessed on a 10 point Likert scale., Between 30 minutes and 2 hours|Enjoyment of the first scenario chosen, Enjoyment of the first scenario chosen assessed on a 10 point Likert scale., Between 30 minutes and 2 hours|Overall satisfaction, Overall satisfaction with the experience assessed on a 10 point Likert scale, Between 30 minutes and 2 hours|NOL index readings, NOL index readings over time per patient, assessed continuously., Between 1 hour and 3 hours