Noise-cancelling headsets to reduce sedation during knee replacement
Official title: Minimal Sedation During Total Knee Arthroplasty: A Prospective Randomized Control Trial
Run by Mayo Clinic · NCT07371390 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Status | Recruiting |
| Started | December 11, 2025 |
| Main results expected | November 24, 2026 |
| Study ends | May 1, 2027 |
| Registry record updated | January 27, 2026 |
| Trial ID | NCT07371390 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) scheduled for primary total knee arthroplasty under spinal anesthesia who can give informed consent are eligible.
✕Probably not a fit
Patients needing general anesthesia or undergoing unicompartmental or revision knee arthroplasty are excluded and would not benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.