Minimal Sedation During Knee Replacement Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Active Noise Cancelling Headset System.
- Who it may be relevant to
- Registry conditions: Total Knee Arthroplasty. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Minimal Sedation During Total Knee Arthroplasty: A Prospective Randomized Control Trial
Overview
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.
Interventions
- 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.
Primary outcome measures
- Mean Richmond Agitation-Sedation Scale(RASS) Score [Time frame: 30 minutes intraoperatively]
- Protocol Completion [Time frame: Intraoperatively]
- Mean Propofol Infusion Rate [Time frame: Intraoperatively]
Secondary outcome measures (3)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Mayo Clinic — Rochester
Identifiers
NCT: NCT07371390 · 25-010602