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NCT Number: NCT07371390

Minimal Sedation During Knee Replacement Surgery

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.

Recruiting

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Key information

Conditions

Total Knee Arthroplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Mean Richmond Agitation-Sedation Scale(RASS) Score

    Time frame: 30 minutes intraoperatively

    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.

  2. Protocol Completion

    Time frame: Intraoperatively

    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.

  3. Mean Propofol Infusion Rate

    Time frame: Intraoperatively

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

Secondary outcomes

  1. Patient Satisfaction

    Time frame: Within 48 hours post-operatively

    Patients will complete a satisfaction questionnaire post-operatively to determine their level of comfort with the sedation protocol they received during surgery.

  2. Surgeon Satisfaction

    Time frame: Within 48 hours post-operatively

    Surgeons will be asked if they experienced interruptions or difficulty completing the procedure due to the sedation protocol administered to the patient.

  3. Anesthetist Satisfaction

    Time frame: Within 48 hours post-operatively

    Anesthesia staff will receive a questionnaire regarding satisfaction with efficacy of the sedation protocol administered during the surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriel D Schouten

CONTACT

[email protected]

507-266-5895

Matthew Hoplin

CONTACT

[email protected]

507-284-1003

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 27, 2026
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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