Propofol, Virtual Reality
Conditions
Keywords
Virtual reality, Anxiety, Patient-controlled sedation, Pain, Propofol, Breast surgery
Brief 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.
Detailed description
Virtual reality (VR) has carved out a growing place for itself in our leisure activities, video games and even in medicine. Recent studies show that VR can reduce anxiety and pain in patients undergoing uncomfortable care (e.g. wound care, dental care, venous access). While the population most frequently investigated is pediatric, the benefits can be extended to other populations. The operating room is uncommon due to the type of procedure and the older patient profile. Yet, with the democratization of regional and neuraxial anesthesia, VR could improve the patient experience in the operating room. The main objective of this study is to explore the impact of VR on intravenous (I.V.) sedation requirements in adult patients undergoing breast surgery under paravertebral (PV) block. The hypothesis is that VR will serve as an effective distraction in the operative context, reducing the need for pharmacology. In parallel, multiple secondary objectives will also be explored, such as the evaluation of the tolerance to the VR headset, the impact of the chosen type of scenario on the primary outcome, the incidence of adverse effects, the variation of the Nociception Level Index (NOL index) in awake patients as well as overall patient satisfaction. This single center, open-label, randomized controlled trial will be conducted in a Canadian academic hospital. 100 patients above the age of 18 years undergoing breast surgery (mastectomy, reduction, augmentation, reconstruction, etc.) under regional anesthesia, specifically paravertebral block, will be included in this study. Patients will be randomized either to the intervention group or the control group. The intervention group will have a VR helmet and the control group a standard treatment. Both will have access to patient-controlled sedation (PCS), self-administering their own sedation under clinical observation. Patients in the VR group will be able to choose, before the procedure begins, between 3 different VR environments and will also be allowed to switch between these environments during the surgery. The primary outcome of this study will be the time-weighted dose of propofol (sedative) self-administered during the procedure. Secondary outcomes will include patient satisfaction, premature removal of VR helmet, presence of nausea, desaturation, hypotension and post-anesthesia monitoring time.
Interventions
DEVICEVirtual 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.
OTHERStandard of care
Standard of care in anesthesia with patient-controlled sedation.
Sponsors
Paperplane Therapeutics
Ciusss de L'Est de l'Île de Montréal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
After the participants meet all the inclusion criteria and meet no exclusion criteria, patients will then be randomized by an unbiased algorithm in a 1 for 1 ratio (one control patient for each patient in the virtual reality group). However, the chosen scenario in the virtual reality group will be a result of each patient's personal preference; the patients will also be able to switch between scenarios at will.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Fully consented female patients above the age of 18 years; * Undergoing elective, awake, breast surgery performed under paravertebral block.
Exclusion criteria
* Hearing or visual impairment; * History of epilepsy, seizure or severe dizziness; * Severe mental impairment; * Recent eye or facial surgery or wounds; * Inability to use the VR hand controller.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Propofol self-administration | Between 1 hour and 3 hours | Time-adjusted and weight-adjusted average self-administration of propofol in mcg/kg/min in female patients undergoing breast surgery under paravertebral block. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preoperative anxiety | Up to 1 hour | Level of anxiety before the surgery evaluated by the Amsterdam Preoperative Anxiety and Information Scale. |
| Remifentanil administration | Between 1 hour and 3 hours | Time-adjusted and weight-adjusted average administration of remifentanil in mcg/kg/min. |
| Ketamine administration | Between 1 hour and 3 hours | Weight-adjusted administration of ketamine in mg/kg. |
| Adverse events | Between 1 hour and 3 hours | The incidence of adverse events such as cybersickness, nausea, bradycardia, desaturation and hypotension. |
| Scenario switches | Between 1 hour and 3 hours | Percentage of patients that switched scenarios. |
| Virtual reality usage | Between 1 hour and 3 hours | 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. |
| NOL index readings | Between 1 hour and 3 hours | NOL index readings over time per patient, assessed continuously. |
| Virtual reality headset removal | Between 1 hour and 3 hours | Percentage of patients that removed the headset before the end of the surgery. |
| Post-Anesthesia Care Unit stay | Between 30 minutes and 2 hours | The total time in minutes spent in the PACU. |
| Enthusiasm at the idea of using virtual reality | Up to 1 hour | Initial enthusiasm at the idea of using a VR headset during surgery assessed on a 10 point Likert scale. |
| Ease of use | Between 30 minutes and 2 hours | Ease of use of the virtual reality technology assessed on a 10 point Likert scale. |
| Enjoyment of the first scenario chosen | Between 30 minutes and 2 hours | Enjoyment of the first scenario chosen assessed on a 10 point Likert scale. |
| Overall satisfaction | Between 30 minutes and 2 hours | Overall satisfaction with the experience assessed on a 10 point Likert scale |
| Virtual reality usage per first scenario | Between 1 hour and 3 hours | Total duration in minutes spent by the patient on the VR scenario chosen, and the order in which VR scenarios were presented. |
Countries
Canada
Contacts
Primary ContactPascal Laferriere-Langlois, MD, MSc
Backup ContactNadia NG Godin, NR
Outcome results
None listed