Minimal Sedation During Knee Replacement Surgery

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT07371390
Status
Recruiting
Apply to this trial

Conditions

  • Total Knee Arthroplasty

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Active Noise Cancelling Headset System — DEVICE
    The ANC Headset will allow patients to select music or a movie for audiovisual distraction during their surgery. This can be used when patients are not receiving general anesthesia (full sedation) for their surgery.

Study Details

This study will test the use of active noise cancelling headphones with music or a movie during knee replacement surgery. Feedback from the surgical team and from patients regarding the headset system will be gathered to see if using it can reduce the amount of sedation needed during knee replacement procedures that use localized anesthesia.

Key Dates

Start date
Dec 11, 2025
Status verified
Jan 2026
Primary completion
Nov 24, 2026
Completion
May 1, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • No Intervention: No active noise cancelling headset
    This arm will serve as the control group for this randomized trial. Patients in this arm will receive normal standard of care anesthesia during their total knee arthroplasty.
  • Experimental: Active Noise Cancelling Headset
    This arm will provide patients with an active noise cancelling headset system that they may use to select music or a movie for audiovisual distraction during the surgery.

Primary Outcome Measure

Mean Richmond Agitation-Sedation Scale(RASS) Score [ Time Frame: 30 minutes intraoperatively ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905
Gabriel D Schouten
[email protected]
507-266-5895
Matthew Hoplin
[email protected]
507-284-1003
Matthew P Abdel, MD (PRINCIPAL_INVESTIGATOR)

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