<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/NCT03241004</url>
  </required_header>
  <id_info>
    <org_study_id>E-17-705</org_study_id>
    <nct_id>NCT03241004</nct_id>
  </id_info>
  <brief_title>Does Melatonin Affect Anesthetic MAC (Minimum Alveolar Concentration)?</brief_title>
  <official_title>Does Melatonin Affect Anesthetic MAC (Minimum Alveolar Concentration)?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Englewood Hospital and Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Englewood Hospital and Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to determine if anesthetic depth can be deepened non-pharmacologically&#xD;
      through use of sleep masks. This study seeks to demonstrate a relationship between the depth&#xD;
      of anesthesia with application of sleep masks intraoperatively and in the critical care&#xD;
      setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Depth of anesthesia will be monitored, both with a standard sleep mask applied and without,&#xD;
      in each subject using standard electroencephalogram (EEG) readings via forehead leads and&#xD;
      Masimo Sedline 2.0 4-lead EEG monitors.&#xD;
&#xD;
      OR Subjects:&#xD;
&#xD;
      Patients will be induced in a standard fashion using intravenous (IV) anesthetics. A&#xD;
      continuous administration of propofol and inhalational anesthetics will be used for&#xD;
      maintenance of anesthesia. The standard electroencephalogram (EEG) reading via forehead leads&#xD;
      and Masimo Sedline 2.0 4-lead EEG machines will be used to monitor the depth of anesthesia,&#xD;
      both with and without the sleep mask.&#xD;
&#xD;
      ICU Subjects:&#xD;
&#xD;
      Patients will be induced in a standard fashion using intravenous (IV) anesthetics. A&#xD;
      continuous administration of propofol will be used for maintenance of anesthesia. The&#xD;
      standard electroencephalogram (EEG) reading via Masimo Sedline 2.0 4-lead EEG monitors will&#xD;
      be used to track the depth of anesthesia, both with and without the sleep mask.&#xD;
&#xD;
      All Subjects:&#xD;
&#xD;
      In both settings,once baseline EEG readings are established (30 minutes), EEG data will be&#xD;
      recorded and a sleep mask will be applied to the patient for one hour. After one hour (90&#xD;
      minutes), EEG data will be recorded and the sleep mask will be removed. After another hour&#xD;
      (150 minutes), EEG data will be recorded and the mask reapplied. After another hour (210&#xD;
      minutes), EEG data will be recorded and the mask removed. The levels/doses of anesthetic&#xD;
      agent at each time point will also be recorded.&#xD;
&#xD;
      Subjective perception of depth of anesthesia will be obtained by means of a post-procedure&#xD;
      evaluation administered to each subject.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    change in study staffing&#xD;
  </why_stopped>
  <start_date type="Actual">July 7, 2017</start_date>
  <completion_date type="Actual">July 8, 2021</completion_date>
  <primary_completion_date type="Actual">July 8, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>EEG data</measure>
    <time_frame>2 hours</time_frame>
    <description>change in depth of anesthesia from baseline to two hours</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subject perception of depth of anesthesia</measure>
    <time_frame>within 24 hours of reversal of sedation</time_frame>
    <description>post-procedure evaluation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>Intensive Care Unit</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be induced in a standard fashion using intravenous (IV) anesthetics. A continuous administration of propofol will be used for maintenance of anesthesia.&#xD;
Baseline EEG readings will be established for 30 minutes, then EEG data will be recorded and a sleep mask applied to the patient for one hour. After one hour, eye masks will be removed for an hour and reapplied after another hour. During the hour that the mask is off, 2 hours into sedation, EEG data will again be recorded.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Operating Room</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be induced in a standard fashion using intravenous (IV) anesthetics. A continuous administration of propofol and inhalational anesthetics will be used for maintenance of anesthesia.&#xD;
Baseline EEG readings will be established for 30 minutes, then EEG data will be recorded and a sleep mask applied to the patient for one hour. After one hour, eye masks will be removed for an hour and reapplied after another hour. During the hour that the mask is off, 2 hours into sedation, EEG data will again be recorded.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sleep Mask</intervention_name>
    <description>sleep mask applied for two separate 60-minute periods during anesthesia</description>
    <arm_group_label>Intensive Care Unit</arm_group_label>
    <arm_group_label>Operating Room</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female at least 18 years of age.&#xD;
&#xD;
          -  Not pregnant.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Undergoing surgeries expected to last less than 3 hours.&#xD;
&#xD;
          -  Undergoing vascular or neurosurgical procedures.&#xD;
&#xD;
          -  Patients with history of CVA (Cardiovascular accidents or disease) or other&#xD;
             neurological dysfunction.&#xD;
&#xD;
          -  Patients or authorized representatives unable or unwilling to provide informed&#xD;
             consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeff Smok, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Englewood Hospital and Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Englewood Hospital and Medical Center</name>
      <address>
        <city>Englewood</city>
        <state>New Jersey</state>
        <zip>07631</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.englewoodhealth.org/for-healthcare-professionals/clinical-research-center</url>
    <description>Related Info</description>
  </link>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>August 16, 2021</last_update_submitted>
  <last_update_submitted_qc>August 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03241004
org study id: E-17-705
nct id: NCT03241004
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to determine if anesthetic depth can be deepened non-pharmacologically
      through use of sleep masks. This study seeks to demonstrate a relationship between the depth
      of anesthesia with application of sleep masks intraoperatively and in the critical care
      setting.
Depth of anesthesia will be monitored, both with a standard sleep mask applied and without,
      in each subject using standard electroencephalogram (EEG) readings via forehead leads and
      Masimo Sedline 2.0 4-lead EEG monitors.

      OR Subjects:

      Patients will be induced in a standard fashion using intravenous (IV) anesthetics. A
      continuous administration of propofol and inhalational anesthetics will be used for
      maintenance of anesthesia. The standard electroencephalogram (EEG) reading via forehead leads
      and Masimo Sedline 2.0 4-lead EEG machines will be used to monitor the depth of anesthesia,
      both with and without the sleep mask.

      ICU Subjects:

      Patients will be induced in a standard fashion using intravenous (IV) anesthetics. A
      continuous administration of propofol will be used for maintenance of anesthesia. The
      standard electroencephalogram (EEG) reading via Masimo Sedline 2.0 4-lead EEG monitors will
      be used to track the depth of anesthesia, both with and without the sleep mask.

      All Subjects:

      In both settings,once baseline EEG readings are established (30 minutes), EEG data will be
      recorded and a sleep mask will be applied to the patient for one hour. After one hour (90
      minutes), EEG data will be recorded and the sleep mask will be removed. After another hour
      (150 minutes), EEG data will be recorded and the mask reapplied. After another hour (210
      minutes), EEG data will be recorded and the mask removed. The levels/doses of anesthetic
      agent at each time point will also be recorded.

      Subjective perception of depth of anesthesia will be obtained by means of a post-procedure
      evaluation administered to each subject.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: EEG data
time frame: 2 hours
description: change in depth of anesthesia from baseline to two hours
measure: Subject perception of depth of anesthesia
time frame: within 24 hours of reversal of sedation
description: post-procedure evaluation
arm group label: Intensive Care Unit
arm group type: Experimental
description: Patients will be induced in a standard fashion using intravenous (IV) anesthetics. A continuous administration of propofol will be used for maintenance of anesthesia.
Baseline EEG readings will be established for 30 minutes, then EEG data will be recorded and a sleep mask applied to the patient for one hour. After one hour, eye masks will be removed for an hour and reapplied after another hour. During the hour that the mask is off, 2 hours into sedation, EEG data will again be recorded.
arm group label: Operating Room
arm group type: Experimental
description: Patients will be induced in a standard fashion using intravenous (IV) anesthetics. A continuous administration of propofol and inhalational anesthetics will be used for maintenance of anesthesia.
Baseline EEG readings will be established for 30 minutes, then EEG data will be recorded and a sleep mask applied to the patient for one hour. After one hour, eye masks will be removed for an hour and reapplied after another hour. During the hour that the mask is off, 2 hours into sedation, EEG data will again be recorded.
intervention type: Other
intervention name: Sleep Mask
description: sleep mask applied for two separate 60-minute periods during anesthesia
arm group label: Intensive Care Unit
arm group label: Operating Room
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jeff Smok, MD
role: Principal Investigator
affiliation: Englewood Hospital and Medical Center
facility: 
country: United States
url: http://www.englewoodhealth.org/for-healthcare-professionals/clinical-research-center
description: Related Info
responsible party type: Sponsor