Noise-cancelling headsets to reduce sedation during knee replacement
Minimal Sedation During Total Knee Arthroplasty: A Prospective Randomized Control Trial
This study will test whether giving people having total knee replacement active noise-cancelling headphones with music or a movie during spinal anesthesia can reduce how much sedation they need.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT07371390 on ClinicalTrials.gov |
What this trial studies
This interventional study uses an active noise-cancelling headset system playing music or movies for patients undergoing primary total knee arthroplasty with spinal anesthesia. Patients and the surgical team will provide feedback on the headset system and the operating-room experience. The study will track how much sedation is used during surgery to see if the headset can reduce sedative dosing. Outcomes focus on patient comfort, team workflow, and sedative requirements during the procedure.
Who should consider this trial
Good fit: Adults (18+) scheduled for primary total knee arthroplasty under spinal anesthesia who can give informed consent are eligible.
Not a fit: Patients needing general anesthesia or undergoing unicompartmental or revision knee arthroplasty are excluded and would not benefit from this intervention.
Why it matters
Potential benefit: If successful, the approach could lower sedative exposure during knee replacement and improve patient comfort during awake spinal anesthesia.
How similar studies have performed: Smaller studies of music or audiovisual distraction during regional anesthesia have reported reduced anxiety and sedative use, but the specific use of active noise-cancelling headsets in total knee replacement is not yet well established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Primary Total Knee Arthroplasty * Indicated for Spinal Anesthesia * 18+ years old * Participant can independently provide informed consent Exclusion Criteria: * Unicompartmental Knee Arthroplasty * Revision Knee Arthroplasty
Where this trial is running
Rochester, Minnesota
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Matthew P Abdel, MD — Mayo Clinic
- Study coordinator: Gabriel D Schouten
- Email: schouten.gabriel@mayo.edu
- Phone: 507-266-5895
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.