<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03285243</url>
  </required_header>
  <id_info>
    <org_study_id>H-39878</org_study_id>
    <nct_id>NCT03285243</nct_id>
  </id_info>
  <brief_title>Effect of Monochromatic Light on Incidence of Emergence Delirium in Children</brief_title>
  <official_title>Effect of Monochromatic Light on Incidence of Emergence Delirium in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Baylor College of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Emergence delirium/emergence agitation (ED/EA) is a behavioral phenomenon of unclear etiology&#xD;
      consisting of short lived behavioral changes that can be both traumatic to families and pose&#xD;
      a safety risk to patients and staff. ED is characterized by a variety of presentations,&#xD;
      including crying, excitation and agitation, that occur during the early stage of recovery&#xD;
      from general anesthesia, generally in the first 30 minutes. Emergence delirium occurs in&#xD;
      children of all ages following an anesthetic with halogenated agents (e.g.&#xD;
      sevoflurane/isoflurane) with or without having undergone a surgical procedure (e.g. MRI&#xD;
      patients). Presently, the treatment for ED is to revert the patient back to a hypnotic state&#xD;
      mainly with sedatives so that they may &quot;reset&quot; themselves postulating that by re-inducing a&#xD;
      hypnotic state, the brain has time to resolve this issue. The hypothesis of this study is&#xD;
      that during ED, there is failure of organized EEG activity, especially alpha wave activity&#xD;
      and that by enhancing alpha activity, the incidence of ED may be reduced without the need for&#xD;
      additional pharmaceuticals which may be costly, delay recovery and are not without adverse&#xD;
      effects specifically cardiopulmonary depression through the use of blue monochromatic light.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Emergence delirium/emergence agitation (ED/EA) is a behavioral phenomenon of unclear etiology&#xD;
      consisting of short lived behavioral changes that can be both traumatic to families and pose&#xD;
      a safety risk to patients and staff. ED is characterized by a variety of presentations,&#xD;
      including crying, excitation and agitation, that occur during the early stage of recovery&#xD;
      from general anesthesia, generally in the first 30 minutes. Involuntary activity in the bed&#xD;
      and even thrashing about during an episode of ED can lead to dislodgement of IV cannulas,&#xD;
      surgical dressings and or surgically placed items such as drains and catheters. Emergence&#xD;
      delirium occurs in children of all ages following an anesthetic with halogenated agents (e.g.&#xD;
      sevoflurane/isoflurane) with or without having undergone a surgical procedure (e.g. MRI&#xD;
      patients). Electroencephalograms (EEG) in patients experiencing emergence delirium show&#xD;
      diffuse background slowing. Presently, the treatment for ED is to revert the patient back to&#xD;
      a hypnotic state mainly with sedatives so that they may &quot;reset&quot; themselves postulating that&#xD;
      by re-inducing a hypnotic state, the brain has time to resolve this issue. The hypothesis of&#xD;
      this study is that during ED, there is failure of organized EEG activity, especially alpha&#xD;
      wave activity and that by enhancing alpha activity, the incidence of ED may be reduced&#xD;
      without the need for additional pharmaceuticals which may be costly, delay recovery and are&#xD;
      not without adverse effects specifically cardiopulmonary depression.&#xD;
&#xD;
      Monochromatic light (ML) has been used in a variety of clinical and non-clinical applications&#xD;
      to affect a variety of changes. Exposure to light of short wavelength within the visible&#xD;
      spectrum (450-470nm) has been associated with effects on circadian rhythm, neuroendocrine and&#xD;
      neurobehavioral changes and enhanced cognitive performance. Blue ML has been studied safely&#xD;
      to enhance work-place alertness and productivity. Clinically, blue ML has been used safely&#xD;
      for decades in the neonatal intensive care unit to treat jaundice.&#xD;
&#xD;
      Blue ML, has been known to suppress melatonin secretion and enhance alertness and workplace&#xD;
      performance. The effect occurs within the retinal photoreceptive ganglion cells which mediate&#xD;
      the observed responses. The effect is even present in visually blind persons lacking outer&#xD;
      retinal function. Short exposure to bursts of blue light has revealed enhanced neural&#xD;
      activity on functional MRI. Use of blue ML has been shown to enhance EEG activity in the&#xD;
      alpha range (awake range) compared with light of greater wavelengths. Using blue ML in the&#xD;
      operating room may enhance alpha EEG activity, (a circadian marker for alertness) it may be&#xD;
      possible to reduce the incidence of emergence delirium in the post-operative period and&#xD;
      therefore the amount of (non-pain) sedative medication needed in recovery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">April 30, 2020</completion_date>
  <primary_completion_date type="Actual">April 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>This is a double blinded randomized control trial. The placebo arm will serve as the control group. After enrollment and consent, each patient will be randomized to either placebo or intervention group. 110 sealed envelopes randomizing patients to the exposure group A (monochromatic light) or bulb B (placebo) white light bulb with blue outer coating.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
    <masking_description>After enrollment and consent, each patient will be randomized to either placebo or intervention group. 110 sealed envelopes randomizing patients to the exposure group A (monochromatic light) or bulb B (placebo) white light bulb with blue outer coating. The recover room nursing staff will evaluate the patient using the PAED standard emergence delirium scale unaware of which light is monochromatic.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Identify if monochromatic light reduces subjective incidence of emergence delirium</measure>
    <time_frame>30 minutes</time_frame>
    <description>Assessment if monochromatic light reduces incidence of emergence delirium</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Calculate the percent reduction in PAED scores in patients exposed to monochromatic light</measure>
    <time_frame>30 minutes</time_frame>
    <description>Assessment of Pediatric Emergence Delirium Scale (PAED) scores at varying points during the initial recovery phase in patients exposure to monochromatic light vs. sham</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">105</enrollment>
  <condition>Emergence Delirium</condition>
  <condition>Anesthesia Emergence Delirium</condition>
  <arm_group>
    <arm_group_label>Blue light - non monochromatic</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Monochromatic blue light</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Monochromatic blue light</intervention_name>
    <description>Exposure to monochromatic light for the first 30 minutes in the recovery period after anesthesia to assess incidence of emergence delirium as noted by the PAED scale</description>
    <arm_group_label>Blue light - non monochromatic</arm_group_label>
    <arm_group_label>Monochromatic blue light</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologist Classification of 1,2&#xD;
&#xD;
          -  Patients ages 2-6 years&#xD;
&#xD;
          -  Routine tonsillectomy and adenoidectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        American Society of Anesthesiology classification other than 1,2; history of migraine&#xD;
        headaches; ocular disorders; seizure history; psychiatric conditions; anxiety; parental&#xD;
        refusal; developmental delay; patients on medication for attention deficit disorders or&#xD;
        caffeine stimulants; Patients with contraindications to receiving inhalation agents; Use of&#xD;
        premedication with midazolam or dexmedetomidine;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adam Adler, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baylor College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Texas childrens Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>March 4, 2021</last_update_submitted>
  <last_update_submitted_qc>March 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baylor College of Medicine</investigator_affiliation>
    <investigator_full_name>Adam Adler MD, MS, FAAP</investigator_full_name>
    <investigator_title>Assistant Professor of Anesthesiology</investigator_title>
  </responsible_party>
  <keyword>Delirium, anesthesia, pediatrics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delirium</mesh_term>
    <mesh_term>Emergence Delirium</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Patient Data will be kept on file and disclosed at discretion of the PI in accordance with Baylor College of Medicine regulations</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>April 13, 2021</submitted>
    <returned>May 7, 2021</returned>
    <submitted>May 13, 2021</submitted>
    <returned>June 8, 2021</returned>
    <submitted>September 29, 2021</submitted>
    <returned>October 26, 2021</returned>
    <submitted>July 5, 2023</submitted>
    <returned>July 24, 2023</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03285243
org study id: H-39878
nct id: NCT03285243
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Emergence delirium/emergence agitation (ED/EA) is a behavioral phenomenon of unclear etiology
      consisting of short lived behavioral changes that can be both traumatic to families and pose
      a safety risk to patients and staff. ED is characterized by a variety of presentations,
      including crying, excitation and agitation, that occur during the early stage of recovery
      from general anesthesia, generally in the first 30 minutes. Emergence delirium occurs in
      children of all ages following an anesthetic with halogenated agents (e.g.
      sevoflurane/isoflurane) with or without having undergone a surgical procedure (e.g. MRI
      patients). Presently, the treatment for ED is to revert the patient back to a hypnotic state
      mainly with sedatives so that they may "reset" themselves postulating that by re-inducing a
      hypnotic state, the brain has time to resolve this issue. The hypothesis of this study is
      that during ED, there is failure of organized EEG activity, especially alpha wave activity
      and that by enhancing alpha activity, the incidence of ED may be reduced without the need for
      additional pharmaceuticals which may be costly, delay recovery and are not without adverse
      effects specifically cardiopulmonary depression through the use of blue monochromatic light.
Emergence delirium/emergence agitation (ED/EA) is a behavioral phenomenon of unclear etiology
      consisting of short lived behavioral changes that can be both traumatic to families and pose
      a safety risk to patients and staff. ED is characterized by a variety of presentations,
      including crying, excitation and agitation, that occur during the early stage of recovery
      from general anesthesia, generally in the first 30 minutes. Involuntary activity in the bed
      and even thrashing about during an episode of ED can lead to dislodgement of IV cannulas,
      surgical dressings and or surgically placed items such as drains and catheters. Emergence
      delirium occurs in children of all ages following an anesthetic with halogenated agents (e.g.
      sevoflurane/isoflurane) with or without having undergone a surgical procedure (e.g. MRI
      patients). Electroencephalograms (EEG) in patients experiencing emergence delirium show
      diffuse background slowing. Presently, the treatment for ED is to revert the patient back to
      a hypnotic state mainly with sedatives so that they may "reset" themselves postulating that
      by re-inducing a hypnotic state, the brain has time to resolve this issue. The hypothesis of
      this study is that during ED, there is failure of organized EEG activity, especially alpha
      wave activity and that by enhancing alpha activity, the incidence of ED may be reduced
      without the need for additional pharmaceuticals which may be costly, delay recovery and are
      not without adverse effects specifically cardiopulmonary depression.

      Monochromatic light (ML) has been used in a variety of clinical and non-clinical applications
      to affect a variety of changes. Exposure to light of short wavelength within the visible
      spectrum (450-470nm) has been associated with effects on circadian rhythm, neuroendocrine and
      neurobehavioral changes and enhanced cognitive performance. Blue ML has been studied safely
      to enhance work-place alertness and productivity. Clinically, blue ML has been used safely
      for decades in the neonatal intensive care unit to treat jaundice.

      Blue ML, has been known to suppress melatonin secretion and enhance alertness and workplace
      performance. The effect occurs within the retinal photoreceptive ganglion cells which mediate
      the observed responses. The effect is even present in visually blind persons lacking outer
      retinal function. Short exposure to bursts of blue light has revealed enhanced neural
      activity on functional MRI. Use of blue ML has been shown to enhance EEG activity in the
      alpha range (awake range) compared with light of greater wavelengths. Using blue ML in the
      operating room may enhance alpha EEG activity, (a circadian marker for alertness) it may be
      possible to reduce the incidence of emergence delirium in the post-operative period and
      therefore the amount of (non-pain) sedative medication needed in recovery.
allocation: Randomized
intervention model: Single Group Assignment
intervention model description: This is a double blinded randomized control trial. The placebo arm will serve as the control group. After enrollment and consent, each patient will be randomized to either placebo or intervention group. 110 sealed envelopes randomizing patients to the exposure group A (monochromatic light) or bulb B (placebo) white light bulb with blue outer coating.
primary purpose: Prevention
masking: Double (Participant, Care Provider)
masking description: After enrollment and consent, each patient will be randomized to either placebo or intervention group. 110 sealed envelopes randomizing patients to the exposure group A (monochromatic light) or bulb B (placebo) white light bulb with blue outer coating. The recover room nursing staff will evaluate the patient using the PAED standard emergence delirium scale unaware of which light is monochromatic.
measure: Identify if monochromatic light reduces subjective incidence of emergence delirium
time frame: 30 minutes
description: Assessment if monochromatic light reduces incidence of emergence delirium
measure: Calculate the percent reduction in PAED scores in patients exposed to monochromatic light
time frame: 30 minutes
description: Assessment of Pediatric Emergence Delirium Scale (PAED) scores at varying points during the initial recovery phase in patients exposure to monochromatic light vs. sham
arm group label: Blue light - non monochromatic
arm group type: Sham Comparator
arm group label: Monochromatic blue light
arm group type: Experimental
intervention type: Device
intervention name: Monochromatic blue light
description: Exposure to monochromatic light for the first 30 minutes in the recovery period after anesthesia to assess incidence of emergence delirium as noted by the PAED scale
arm group label: Blue light - non monochromatic
arm group label: Monochromatic blue light
criteria: 
gender: All
minimum age: 2 Years
maximum age: 6 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Adam Adler, MD
role: Principal Investigator
affiliation: Baylor College of Medicine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Baylor College of Medicine
investigator full name: Adam Adler MD, MS, FAAP
investigator title: Assistant Professor of Anesthesiology
mesh term: Delirium
mesh term: Emergence Delirium
sharing ipd: Undecided
ipd description: Patient Data will be kept on file and disclosed at discretion of the PI in accordance with Baylor College of Medicine regulations
submitted: April 13, 2021
returned: May 7, 2021
submitted: May 13, 2021
returned: June 8, 2021
submitted: September 29, 2021
returned: October 26, 2021
submitted: July 5, 2023
returned: July 24, 2023