Total Knee Arthroplasty
Conditions
Keywords
Spinal Anesthesia, Minimal Sedation, Total Knee Arthroplasty, Knee Replacement, Audiovisual Distraction, Localized Anesthesia
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.
Interventions
DEVICEActive 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.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Richmond Agitation-Sedation Scale(RASS) Score | 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 | 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 | Intraoperatively | Mean rate of propofol infusion necessary to achieve sedation targets during the procedure. Unit: mcg/kg/min |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | 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. |
| Surgeon Satisfaction | 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. |
| Anesthetist Satisfaction | Within 48 hours post-operatively | Anesthesia staff will receive a questionnaire regarding satisfaction with efficacy of the sedation protocol administered during the surgery. |
Countries
United States
Contacts
CONTACTGabriel D Schouten
CONTACTMatthew Hoplin
PRINCIPAL_INVESTIGATORMatthew P Abdel, MD
Mayo Clinic
Outcome results
None listed