Music Distraction and Its Influence on Anesthetic Requirements During Elective Knee Surgery

Prior to surgery, patient participants will receive a combined spinal-epidural per VCU total
joint protocol; the following steps are considered standard of care and not considered study
procedures. The combined spinal-epidural procedure creates complete numbness below the
abdomen down to the feet, which negates the need for general anesthesia. For patient comfort
during the combined-spinal epidural procedure, a one-time dose of 2 milligrams of intravenous
midazolam will be given; this dose is adequate for reducing anxiety while allowing the
patient to maintain conversation with health care providers if necessary. The standard
intrathecal dose for total knee replacement at our institution is 15 mg bupivacaine and 0.2
mg preservative-free morphine; this dose will provide complete numbness to the lower
extremities for approximately 3-6 hours. After this dose is administered, the patient will
then be positioned appropriately in the operating room and vital signs will monitored per
standard protocol.

Each patient participant will be randomized to one of two groups. Participants in the control
group will receive noise-cancelling wireless headphones that will not play any noise
throughout the procedure. Participants in the experimental group will receive the same
noise-cancelling wireless headphones but will be permitted to listen to the music of their
choice while in the operating room. Music will be provided via Spotify, which is an Internet
streaming music service, and will be played through headphones; this way, no other individual
in the operating room will be distracted or influenced by the patient's music selection.
Participants will not be able to change the Spotify channel. We will be using the paid
Spotify service with no commercials. If participants opt to have the music stopped, we will
withdraw them from the study and continue standard of care. The participants will have the
music playing for about two hours. If the participant has no music preference, the music will
be chosen for them and it will be the same for all participants that have no preference. The
volume will be adjusted in the operating room until the participant approves of the volume by
saying "yes, the volume is good" or giving another verbal cue of approval.The music will
continue playing until the surgical procedure is complete and the patient has reached the
post-anesthesia recovery unit.

As stated previously, spinal anesthesia provides numbness that negates the need for general
anesthesia, but patients often times need additional sedation, which will be defined as
anesthesia medication that is used to treat patient anxiety and discomfort in the operating
room. Patient participants in both groups will receive sedation via the same protocol, which
is outlined below.

Sedation will only be given as needed per patient request; the patient will be given a
noise-making device (such as a rubber duckie that makes sound when squeezed) that will inform
the anesthesia provider that the patient is uncomfortable and needs some sedation. A weight
based dose of 0.3 micrograms per kilogram of intravenous propofol will be given for each
patient request. This dose is expected to provide amnesia or light sleep for a few minutes.
For patient safety, if the patient requests sedation more than once within a two minute
window, the anesthesia provider will not administer any more medication during this two
minute period. Additionally, the anesthesia provider may withhold sedation if he or she
determines with physical exam and hemodynamic monitors that the patient is already
over-sedated.

After five propofol boluses have been given to a patient, a propofol continuous infusion will
be initiated at 25mcg/kg/min. The patient may still request additional sedation with the
request instrument if he or she is still conscious enough to do so. If the anesthesia
provider has given more than five boluses even with the baseline propofol infusion, the
infusion will be increased to 50mcg/kg/min. In the highly unlikely scenario that five
additional boluses are required with a propofol infusion rate of 50 mcg/kg/min, the
anesthesia providers and investigators will make a clinical decision as to what is the safest
next step.

There may be scenarios that warrant conversion to general anesthesia. These scenarios
include, but are not limited to, hemodynamic instability, regurgitation of gastric content,
obtundation, excessive agitation, and inadequate spinal anesthesia. The decision to convert
to the general anesthesia will be made by the anesthesiologist and anesthesia provider in the
operating room; implementation of this study should not prevent or delay this decision if it
is necessary.

Documentation will be completed by the anesthesia provider per standard protocol for
electronic anesthesia charting at VCU. This will allow for data acquisition by the
investigators through the anesthesiology printed record in Cerner.

Inclusion Criteria:

1. undergoing a primary elective total knee replacement by Dr. Gregory Golladay (VCU
surgeon and co-investigator for this research study)

2. 18 years of age or older

3. eligible for spinal anesthesia (which will be determined by the health care providers
during the standard pre-surgery clinic visits)

4. mentally capable of understanding instructions on how to request anesthesia medication

5. mentally capable of understanding instructions on how to rate pain scores, anxiety
level, and patient satisfaction

Exclusion Criteria:

1. identified as a member of a regulated vulnerable population (one exception: limited
English proficiency does not preclude them from this study; translation documents are
available)

2. ineligibility for spinal anesthesia (which will be determined by the health care
providers during the standard pre-surgery clinic visits)

3. morbid obesity, BMI greater than 40

4. allergy to propofol, midazolam, or morphine

5. pre-operative daily opioid consumption of more than 10 mg oxycodone every 6 hours

6. hearing impaired individuals