Clinical trial
Can we Avoid Intravenous Sedation in Patients Undergoing Knee Surgery Under Spinal Anesthesia? A Prospective Randomized Controlled Study Comparing Virtual Reality Hypnosis to Standard of Care
Name
VRH.TKA
Description
For many years, total knee arthroplasty (TKA) has been a common and effective procedure to treat chronic refractory joint pain. Although efforts must be pursued, as general anesthesia remains the main tendency for TKA. Currently, the standard of care to manage procedural anxiety is pharmacological sedation; i.e. the intravenous administration of additional anesthetic agents such as propofol or midazolam. However, pharmacological sedation has considerable undesirable side effects. Hence, risks of intraprocedural adverse events including respiratory depression, hemodynamic perturbations, or paradoxical effects such as hostility, aggression, and psychomotor agitation, are increased. The goal of this prospective, single-center, randomized controlled clinical trial is to systematically evaluate the impact of implementing a protocol of virtual reality hypnosis in patients undergoing total knee arthroplasty under spinal anesthesia.
Trial arms
Trial start
2023-02-15
Estimated PCD
2023-08-03
Trial end
2023-08-03
Status
Completed
Phase
Early phase I
Treatment
VRH
The VR headset and headphones will be placed on patients after the spinal anesthesia, once the patient is positioned and the surgical drapes installed. Patients will then undergo a 120-minute Digital Sedation™ program (Aqua+© 120 Version 1.1 or subsequent version, Oncomfort SA, Waver, Belgium). They will experience an underwater experience while listening to hypnotic script designed to induce a change in state of consciousness, increasing parasympathetic system tone and relaxation response, and reducing the perception of painful stimuli. While the session is running, HCPs can see what is projected into the VRH headset on their Sedakit's X2 controller (i.e. the tablet connected to the glasses).
Arms:
VRH Group
Midazolam sedation
During the procedure, the patient in the control group receives pharmacological sedation, which is the standard of care currently practiced. Such sedation allows intraoperative anxiolysis, which is constantly required by patients in order to dissociate from their surroundings. Recall that total knee replacement surgery is extremely noisy, and the surrounding environment is itself an anxiety-provoking factor for the patient. Light to moderate, intraoperative sedation is carried out by intermittent boluses of midazolam 1 mg IV. Boluses are given every 5 minutes until a sedation level of -2 or -3 on the RASS (Richmond Agitation-Sedation Scale) scale is reached.
Arms:
Control Group, VRH Group
Size
60
Primary endpoint
Midazolam milligrams
2 hours
Eligibility criteria
Inclusion Criteria:
* Patients \>18 yo and scheduled for elective knee arthroplasty under spinal anesthesia
Exclusion Criteria:
1. Low auditory and/or visual acuity that precludes the use of the device.
2. ASA status \> 3
3. Head or face wounds precluding use of the device.
4. Schizophrenia or dissociative disorder.
5. Pregnancy.
6. Chronic renal insufficiency or severe hepatic insufficiency.
7. Non-proficiency in French (Research language).
8. Phobia of deep water.
9. Chronic pain and/or chronic analgesics consumption.
10. Medication affecting the autonomic nervous system.
11. Revision surgery.
12. Dizziness.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective, single-center, randomized controlled clinical trial', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}
Updated at
2024-03-06
1 organization
Organization
University of Liege