Virtual Reality for Anxiolysis and Pharmacological Sparing
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCiusss de L'Est de l'Île de Montréal
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Fully consented female patients above the age of 18 years;
Undergoing elective, awake, breast surgery performed under paravertebral block.
Disqualifiers
Hearing or visual impairment;
History of epilepsy, seizure or severe dizziness;
Severe mental impairment;
Recent eye or facial surgery or wounds;
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual reality headset
DeviceA 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.
Standard of care
Other interventionStandard of care in anesthesia with patient-controlled sedation.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Virtual realityExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Between 1 hour and 3 hoursSecondary outcomes
1
Preoperative anxiety
Level of anxiety before the surgery evaluated by the Amsterdam Preoperative Anxiety and Information Scale.
Time frame
Up to 1 hour2
Remifentanil administration
Time-adjusted and weight-adjusted average administration of remifentanil in mcg/kg/min.
Time frame
Between 1 hour and 3 hours3
Ketamine administration
Weight-adjusted administration of ketamine in mg/kg.
Time frame
Between 1 hour and 3 hours4
Adverse events
The incidence of adverse events such as cybersickness, nausea, bradycardia, desaturation and hypotension.
Time frame
Between 1 hour and 3 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ciusss de L'Est de l'Île de Montréal
Lead sponsor
Paperplane Therapeutics
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: