Minimal Sedation During Knee Replacement Surgery

NCT07371390 | Recruiting

• 1 other identifier: 25-010602
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Total Knee Arthroplasty

Keywords

Spinal Anesthesia; Minimal Sedation; Total Knee Arthroplasty; Knee Replacement; Audiovisual Distraction; Localized Anesthesia

Outcome Measures

Primary Outcomes (3)

• Mean Richmond Agitation-Sedation Scale(RASS) Score

  Richmond Agitation-Sedation Scale (RASS) measures the amount of sedation necessary for a patient at different levels of discomfort or agitation during local anesthesia surgeries.

  30 minutes intraoperatively

• Protocol Completion

  This will measure the volume of patients that were unable to complete their procedure using spinal anesthesia and due to discomfort or agitation required deep sedation to continue to surgery.

  Intraoperatively

• Mean Propofol Infusion Rate

  Mean rate of propofol infusion necessary to achieve sedation targets during the procedure. Unit: mcg/kg/min

  Intraoperatively

Secondary Outcomes (3)

• Patient Satisfaction

  Within 48 hours post-operatively

• Surgeon Satisfaction

  Within 48 hours post-operatively

• Anesthetist Satisfaction

  Within 48 hours post-operatively

Study Arms (2)

No active noise cancelling headset

NO INTERVENTION

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

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.

Device: Active Noise Cancelling Headset System

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.

Active Noise Cancelling Headset

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary Total Knee Arthroplasty
• Indicated for Spinal Anesthesia
• + years old
• Participant can independently provide informed consent

You may not qualify if:

• Unicompartmental Knee Arthroplasty
• Revision Knee Arthroplasty

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Study Officials

• Matthew P Abdel, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriel D Schouten

CONTACT

507-266-5895; schouten.gabriel@mayo.edu

Matthew Hoplin

CONTACT

507-284-1003; hoplin.matthew@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Orthopedics

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 27, 2026
• Study Start: December 11, 2025
• Primary Completion (Estimated): November 24, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

US (1)