Minimal Sedation During Knee Replacement Surgery

Mayo Clinic

Status: Enrolling

Conditions: Total Knee Arthroplasty

Treatments: Device: Active Noise Cancelling Headset System

Study type: Interventional

Funder types: Other

Identifiers

NCT07371390

25-010602

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

No active noise cancelling headset

No Intervention group

Description:

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.

Active Noise Cancelling Headset

Experimental group

Description:

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.

Treatment:

Device: Active Noise Cancelling Headset System