Virtual Reality Hypnosis in Total Knee Arthroplasty Under Spinal Anesthesia

• Status: Not yet recruiting
• Trial end date: 2024-01-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Liege
• Treatments: Midazolam

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.