Minimal Sedation During Knee Replacement Surgery

Minimal Sedation During Total Knee Arthroplasty: A Prospective Randomized Control Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Total Knee Arthroplasty
• Intervention / Treatment: Device: Active Noise Cancelling Headset System

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gabriel D Schouten; Phone Number: 507-266-5895; Email: schouten.gabriel@mayo.edu
• Study Contact Backup: Name: Matthew Hoplin; Phone Number: 507-284-1003; Email: hoplin.matthew@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Principal Investigator: Matthew P Abdel, MD
      • Contact: Gabriel D Schouten; Phone Number: 507-266-5895; Email: schouten.gabriel@mayo.edu
      • Contact: Matthew Hoplin; Phone Number: 507-284-1003; Email: hoplin.matthew@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Active Noise Cancelling Headset System; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction	Patients will complete a satisfaction questionnaire post-operatively to determine their level of comfort with the sedation protocol they received during surgery.	Within 48 hours post-operatively
Surgeon Satisfaction	Surgeons will be asked if they experienced interruptions or difficulty completing the procedure due to the sedation protocol administered to the patient.	Within 48 hours post-operatively
Anesthetist Satisfaction	Anesthesia staff will receive a questionnaire regarding satisfaction with efficacy of the sedation protocol administered during the surgery.	Within 48 hours post-operatively

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Matthew P Abdel, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2025
• Primary Completion (Estimated): November 24, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: December 23, 2025
• First Submitted That Met QC Criteria: January 19, 2026
• First Posted (Actual): January 27, 2026

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 19, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Total Knee Arthroplasty; Knee Replacement; Spinal Anesthesia; Minimal Sedation; Audiovisual Distraction; Localized Anesthesia
• Other Study ID Numbers: 25-010602

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Undecided, as publication plan has not been finalized at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No