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


Ontology type: schema:MedicalStudy     


Clinical Trial Info

YEARS

2018-2019

ABSTRACT

This study evaluates the effect of music and its influence on anesthetic requirements during total knee replacement surgery. Half of the participants will receive noise-cancelling headphones in the operating room, and the other half of participants will receive noise-cancelling headphones with music playing. Detailed Description 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. More... »

URL

https://clinicaltrials.gov/show/NCT03486106

Related SciGraph Publications

JSON-LD is the canonical representation for SciGraph data.

TIP: You can open this SciGraph record using an external JSON-LD service: JSON-LD Playground Google SDTT

[
  {
    "@context": "https://springernature.github.io/scigraph/jsonld/sgcontext.json", 
    "about": [
      {
        "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/3053", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "type": "DefinedTerm"
      }
    ], 
    "description": "This study evaluates the effect of music and its influence on anesthetic requirements during total knee replacement surgery. Half of the participants will receive noise-cancelling headphones in the operating room, and the other half of participants will receive noise-cancelling headphones with music playing.\n\nDetailed Description\nPrior 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.", 
    "endDate": "2019-02-01T00:00:00Z", 
    "id": "sg:clinicaltrial.NCT03486106", 
    "keywords": [
      "distraction", 
      "anesthetic", 
      "knee surgery", 
      "music", 
      "knee replacement surgery", 
      "half", 
      "headphone", 
      "room", 
      "General Surgery", 
      "patient", 
      "protocol", 
      "care", 
      "study procedure", 
      "abdomen", 
      "foot", 
      "negate", 
      "general anesthesia", 
      "patient comfort", 
      "Time", 
      "midazolam", 
      "dose", 
      "anxiety", 
      "conversation", 
      "Health Personnel", 
      "Knee Replacement Arthroplasty", 
      "institution", 
      "bupivacaine", 
      "preservative", 
      "low extremity", 
      "vital sign", 
      "standard protocol", 
      "control group", 
      "noise", 
      "method", 
      "experimental group", 
      "Internet", 
      "service", 
      "selection", 
      "commercial", 
      "preference", 
      "volume", 
      "cue", 
      "approval", 
      "surgical procedure", 
      "anesthesia", 
      "spinal anesthesia", 
      "Hypesthesia", 
      "sedation", 
      "patient anxiety", 
      "discomfort", 
      "same protocol", 
      "making", 
      "rubber", 
      "weight", 
      "propofol", 
      "amnesia", 
      "light", 
      "patient safety", 
      "window", 
      "medication", 
      "period", 
      "withhold", 
      "physical exam", 
      "hemodynamics", 
      "continuous infusion", 
      "instrument", 
      "bolus", 
      "baseline", 
      "infusion", 
      "infusion rate", 
      "clinical decision", 
      "safest", 
      "conversion", 
      "hemodynamic instability", 
      "regurgitation", 
      "gastric content", 
      "agitation", 
      "anesthesiologist", 
      "implementation", 
      "delay", 
      "documentation", 
      "electronics", 
      "VCU", 
      "data acquisition", 
      "anesthesiology"
    ], 
    "name": "Music Distraction and Its Influence on Anesthetic Requirements During Elective Knee Surgery", 
    "sameAs": [
      "https://app.dimensions.ai/details/clinical_trial/NCT03486106"
    ], 
    "sdDataset": "clinical_trials", 
    "sdDatePublished": "2019-03-07T15:27", 
    "sdLicense": "https://scigraph.springernature.com/explorer/license/", 
    "sdPublisher": {
      "name": "Springer Nature - SN SciGraph project", 
      "type": "Organization"
    }, 
    "sdSource": "file:///pack/app/us_ct_data_00027.json", 
    "sponsor": [
      {
        "id": "https://www.grid.ac/institutes/grid.224260.0", 
        "type": "Organization"
      }
    ], 
    "startDate": "2018-07-01T00:00:00Z", 
    "subjectOf": [
      {
        "id": "https://doi.org/10.1016/j.jaad.2016.02.1143", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1002046000"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1089/acm.2014.0310", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1059219662"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1080/19932820.2017.1260886", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1083439312"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/j.ctim.2017.03.007", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1084068942"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1186/s12906-017-1669-4", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1084250892", 
          "https://doi.org/10.1186/s12906-017-1669-4"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1186/s12906-017-1669-4", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1084250892", 
          "https://doi.org/10.1186/s12906-017-1669-4"
        ], 
        "type": "CreativeWork"
      }
    ], 
    "type": "MedicalStudy", 
    "url": "https://clinicaltrials.gov/show/NCT03486106"
  }
]
 

Download the RDF metadata as:  json-ld nt turtle xml License info

HOW TO GET THIS DATA PROGRAMMATICALLY:

JSON-LD is a popular format for linked data which is fully compatible with JSON.

curl -H 'Accept: application/ld+json' 'https://scigraph.springernature.com/clinicaltrial.NCT03486106'

N-Triples is a line-based linked data format ideal for batch operations.

curl -H 'Accept: application/n-triples' 'https://scigraph.springernature.com/clinicaltrial.NCT03486106'

Turtle is a human-readable linked data format.

curl -H 'Accept: text/turtle' 'https://scigraph.springernature.com/clinicaltrial.NCT03486106'

RDF/XML is a standard XML format for linked data.

curl -H 'Accept: application/rdf+xml' 'https://scigraph.springernature.com/clinicaltrial.NCT03486106'


 

This table displays all metadata directly associated to this object as RDF triples.

120 TRIPLES      16 PREDICATES      105 URIs      94 LITERALS      1 BLANK NODES

Subject Predicate Object
1 sg:clinicaltrial.NCT03486106 schema:about anzsrc-for:3053
2 schema:description This study evaluates the effect of music and its influence on anesthetic requirements during total knee replacement surgery. Half of the participants will receive noise-cancelling headphones in the operating room, and the other half of participants will receive noise-cancelling headphones with music playing. Detailed Description 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.
3 schema:endDate 2019-02-01T00:00:00Z
4 schema:keywords General Surgery
5 Health Personnel
6 Hypesthesia
7 Internet
8 Knee Replacement Arthroplasty
9 Time
10 VCU
11 abdomen
12 agitation
13 amnesia
14 anesthesia
15 anesthesiologist
16 anesthesiology
17 anesthetic
18 anxiety
19 approval
20 baseline
21 bolus
22 bupivacaine
23 care
24 clinical decision
25 commercial
26 continuous infusion
27 control group
28 conversation
29 conversion
30 cue
31 data acquisition
32 delay
33 discomfort
34 distraction
35 documentation
36 dose
37 electronics
38 experimental group
39 foot
40 gastric content
41 general anesthesia
42 half
43 headphone
44 hemodynamic instability
45 hemodynamics
46 implementation
47 infusion
48 infusion rate
49 institution
50 instrument
51 knee replacement surgery
52 knee surgery
53 light
54 low extremity
55 making
56 medication
57 method
58 midazolam
59 music
60 negate
61 noise
62 patient
63 patient anxiety
64 patient comfort
65 patient safety
66 period
67 physical exam
68 preference
69 preservative
70 propofol
71 protocol
72 regurgitation
73 room
74 rubber
75 safest
76 same protocol
77 sedation
78 selection
79 service
80 spinal anesthesia
81 standard protocol
82 study procedure
83 surgical procedure
84 vital sign
85 volume
86 weight
87 window
88 withhold
89 schema:name Music Distraction and Its Influence on Anesthetic Requirements During Elective Knee Surgery
90 schema:sameAs https://app.dimensions.ai/details/clinical_trial/NCT03486106
91 schema:sdDatePublished 2019-03-07T15:27
92 schema:sdLicense https://scigraph.springernature.com/explorer/license/
93 schema:sdPublisher Nc80391dc23e543f1a173a525fe91b3e4
94 schema:sponsor https://www.grid.ac/institutes/grid.224260.0
95 schema:startDate 2018-07-01T00:00:00Z
96 schema:subjectOf sg:pub.10.1186/s12906-017-1669-4
97 https://doi.org/10.1016/j.ctim.2017.03.007
98 https://doi.org/10.1016/j.jaad.2016.02.1143
99 https://doi.org/10.1080/19932820.2017.1260886
100 https://doi.org/10.1089/acm.2014.0310
101 schema:url https://clinicaltrials.gov/show/NCT03486106
102 sgo:license sg:explorer/license/
103 sgo:sdDataset clinical_trials
104 rdf:type schema:MedicalStudy
105 Nc80391dc23e543f1a173a525fe91b3e4 schema:name Springer Nature - SN SciGraph project
106 rdf:type schema:Organization
107 anzsrc-for:3053 schema:inDefinedTermSet anzsrc-for:
108 rdf:type schema:DefinedTerm
109 sg:pub.10.1186/s12906-017-1669-4 schema:sameAs https://app.dimensions.ai/details/publication/pub.1084250892
110 https://doi.org/10.1186/s12906-017-1669-4
111 rdf:type schema:CreativeWork
112 https://doi.org/10.1016/j.ctim.2017.03.007 schema:sameAs https://app.dimensions.ai/details/publication/pub.1084068942
113 rdf:type schema:CreativeWork
114 https://doi.org/10.1016/j.jaad.2016.02.1143 schema:sameAs https://app.dimensions.ai/details/publication/pub.1002046000
115 rdf:type schema:CreativeWork
116 https://doi.org/10.1080/19932820.2017.1260886 schema:sameAs https://app.dimensions.ai/details/publication/pub.1083439312
117 rdf:type schema:CreativeWork
118 https://doi.org/10.1089/acm.2014.0310 schema:sameAs https://app.dimensions.ai/details/publication/pub.1059219662
119 rdf:type schema:CreativeWork
120 https://www.grid.ac/institutes/grid.224260.0 schema:Organization
 




Preview window. Press ESC to close (or click here)


...