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Virtual Reality for Anxiolysis and Pharmacological Sparing

NCT06522711 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-07-26

No results posted yet for this study

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.

Conditions

  • Virtual Reality
  • Propofol

Interventions

DEVICE

Virtual reality headset

A brief overview of all three virtual reality scenarios will be shown in a consolidated video prior to letting the participant select the preferred scenario. The participant's choice of scenario will then be documented. Once paravertebral blocks are completed and the participants are in supine position and the surgeon is ready to disinfect, the VR headset will be applied on the face of the participants in the intervention group and the chosen scenario will be started. If at any point the patient expresses a desire to stop using VR during the surgery, we will first offer them an alternate scenario. If they reiterate their willingness to stop, with or without having experienced the new scenario, the headset will be removed for the remainder of the surgery.

OTHER

Standard of care

Standard of care in anesthesia with patient-controlled sedation.

Sponsors & Collaborators

  • Paperplane Therapeutics

    collaborator UNKNOWN

  • Ciusss de L'Est de l'Île de Montréal

    lead OTHER

Principal Investigators

  • Pascal Laferriere-Langlois, MD, MSc · Ciusss de L'Est de l'Île de Montréal

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2026-09-01
Completion
2026-09-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06522711 on ClinicalTrials.gov