Total Knee ArthroplastyNCT07371390
Minimal Sedation During Knee Replacement Surgery
A study testing Active Noise Cancelling Headset System in people with Total Knee Arthroplasty, run by Mayo Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Active Noise Cancelling Headset System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2025to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary Total Knee Arthroplasty
- Indicated for Spinal Anesthesia
- 18+ years old
- Participant can independently provide informed consent
Who cannot join
- Unicompartmental Knee Arthroplasty
- Revision Knee Arthroplasty
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Gabriel D Schouten, 507-266-5895, schouten.gabriel@mayo.edu
Matthew Hoplin, 507-284-1003, hoplin.matthew@mayo.edu
About this study
Official title: 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.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Active Noise Cancelling Headset System
- Keywords
- Spinal Anesthesia, Minimal Sedation, Total Knee Arthroplasty, Knee Replacement, Audiovisual Distraction, Localized Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Noise Cancelling Headset SystemDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Active Noise Cancelling Headset System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Intraoperatively
Mean Propofol Infusion Rate
Mean rate of propofol infusion necessary to achieve sedation targets during the procedure. Unit: mcg/kg/min
Measured: Intraoperatively
Secondary outcomes (3)
Patient Satisfaction
Patients will complete a satisfaction questionnaire post-operatively to determine their level of comfort with the sedation protocol they received during surgery.
Measured: 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.
Measured: 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.
Measured: Within 48 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start11 Dec 2025
- Primary completion24 Nov 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew P. Abdel, M.D., Mayo Clinic
- Investigators
- Matthew P Abdel, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07371390
- Sponsor's protocol ID
- 25-010602
- Status last verified
- Jan 2026
- First submitted
- 23 Dec 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided, as publication plan has not been finalized at this time.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal Sedation During Total Knee Arthroplasty: A Prospective Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07371390
- Acronym / sponsor ID
- 25-010602
- Conditions
- Total Knee Arthroplasty
- Keywords
- Spinal Anesthesia, Minimal Sedation, Total Knee Arthroplasty, Knee Replacement, Audiovisual Distraction, Localized Anesthesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 11 Dec 2025 (actual)
- Primary completion
- 24 Nov 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Active Noise Cancelling Headset SystemThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary Total Knee Arthroplasty
- Indicated for Spinal Anesthesia
- 18+ years old
- Participant can independently provide informed consent
Key exclusion criteria (2 listed)
- Unicompartmental Knee Arthroplasty
- Revision Knee Arthroplasty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Noise Cancelling Headset SystemThe 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. | Device | Active Noise Cancelling Headset |
Primary outcome
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.
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.
Mean Propofol Infusion Rate
Time frame: Intraoperatively
Mean rate of propofol infusion necessary to achieve sedation targets during the procedure. Unit: mcg/kg/min
3 secondary outcomes
Patient Satisfaction
Time frame: Within 48 hours post-operatively
Surgeon Satisfaction
Time frame: Within 48 hours post-operatively
Anesthetist Satisfaction
Time frame: Within 48 hours post-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: Undecided. Undecided, as publication plan has not been finalized at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew P Abdel, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Noise Cancelling Headset System in people with Total Knee Arthroplasty, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriel D Schouten (507-266-5895, schouten.gabriel@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Richmond Agitation-Sedation Scale(RASS) Score (time frame: 30 minutes intraoperatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.