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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gabriel D Schouten | Contact | 507-266-5895 | schouten.gabriel@mayo.edu | |
| Matthew Hoplin | Contact | 507-284-1003 | hoplin.matthew@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Matthew P Abdel, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
Undecided, as publication plan has not been finalized at this time.
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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 |