<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/NCT02256358</url>
  </required_header>
  <id_info>
    <org_study_id>2012-127</org_study_id>
    <nct_id>NCT02256358</nct_id>
  </id_info>
  <brief_title>Comparison of Effects of Intravenous Midazolam and Ketamine on Emergence Agitation</brief_title>
  <official_title>Comparison of Effects of Intravenous Midazolam and Ketamine on Emergence Agitation : a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inje University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Inje University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Compare the effects of intravenous midazolam and ketamine on emergence agitation after&#xD;
      sevoflurane anesthesia&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Emergence agitation is self-limiting aggressive behavior that develops in the early period of&#xD;
      awakening from anesthesia. A high level of preoperative anxiety is a risk factor for&#xD;
      emergence agitation using Aono's four-point scale. Midazolam and ketamine was administered to&#xD;
      the patients to decrease of preoperative anxiety. We aimed to compare the emergence agitation&#xD;
      between midazolam group and ketamine group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Emergence Agitation</measure>
    <time_frame>During 30 minutes after extubation at post-anesthetic care unit, every 5 minutes</time_frame>
    <description>The primary endpoint is the incidence of postoperative emergence agitation that was defined as an Aono's four-point scale(AFPS) score of 3 or higher.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Psychomotor Agitation</condition>
  <arm_group>
    <arm_group_label>Midazolam</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ketamine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Midazolam</intervention_name>
    <description>preoperatively injected intravenous 0.1 mg/kg midazolam</description>
    <arm_group_label>Midazolam</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketamine</intervention_name>
    <description>Preoperatively injected intravenous 1mg/kg ketamine</description>
    <arm_group_label>Ketamine</arm_group_label>
    <other_name>Ketamine HCl</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American society of anesthesiologists physical status 1-2 aged 2-6 years old, who were&#xD;
             scheduled to undergo ophthalmic surgery (&lt;2hr)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  children with central nervous system disorders,history of allergy to the study drugs&#xD;
             (midazolam and ketamine), history of recent respiratory tract infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kihwa Lee, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Haeundae paik hospital, inje university</affiliation>
  </overall_official>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>October 1, 2014</study_first_submitted>
  <study_first_submitted_qc>October 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <results_first_submitted>October 6, 2014</results_first_submitted>
  <results_first_submitted_qc>October 6, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 9, 2014</results_first_posted>
  <last_update_submitted>October 9, 2014</last_update_submitted>
  <last_update_submitted_qc>October 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 20, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Inje University</investigator_affiliation>
    <investigator_full_name>Ki Hwa Lee</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <keyword>child, ketamine, midazolam</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psychomotor Agitation</mesh_term>
    <mesh_term>Emergence Delirium</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Midazolam</mesh_term>
    <mesh_term>Ketamine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Midazolam</title>
          <description>Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room.&#xD;
Midazolam: preoperatively injected intravenous 0.1 mg/kg midazolam</description>
        </group>
        <group group_id="P2">
          <title>Ketamine</title>
          <description>Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.&#xD;
Ketamine: Preoperatively injected intravenous 1mg/kg ketamine</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="34"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Midazolam</title>
          <description>Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room.&#xD;
Midazolam: preoperatively injected intravenous 0.1 mg/kg midazolam</description>
        </group>
        <group group_id="B2">
          <title>Ketamine</title>
          <description>Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.&#xD;
Ketamine: Preoperatively injected intravenous 1mg/kg ketamine</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="34"/>
            <count group_id="B2" value="33"/>
            <count group_id="B3" value="67"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>year</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.15" spread="1.40"/>
                    <measurement group_id="B2" value="4.21" spread="1.32"/>
                    <measurement group_id="B3" value="4.18" spread="1.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Emergence Agitation</title>
        <description>The primary endpoint is the incidence of postoperative emergence agitation that was defined as an Aono's four-point scale(AFPS) score of 3 or higher.</description>
        <time_frame>During 30 minutes after extubation at post-anesthetic care unit, every 5 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Midazolam</title>
            <description>Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room.&#xD;
Midazolam: preoperatively injected intravenous 0.1 mg/kg midazolam</description>
          </group>
          <group group_id="O2">
            <title>Ketamine</title>
            <description>Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.&#xD;
Ketamine: Preoperatively injected intravenous 1mg/kg ketamine</description>
          </group>
        </group_list>
        <measure>
          <title>Emergence Agitation</title>
          <description>The primary endpoint is the incidence of postoperative emergence agitation that was defined as an Aono's four-point scale(AFPS) score of 3 or higher.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 day</time_frame>
      <desc>Recording of complications at 5 minutes intervals during 30 minutes after operation</desc>
      <group_list>
        <group group_id="E1">
          <title>Midazolam</title>
          <description>Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room.&#xD;
Midazolam: preoperatively injected intravenous 0.1 mg/kg midazolam</description>
        </group>
        <group group_id="E2">
          <title>Ketamine</title>
          <description>Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.&#xD;
Ketamine: Preoperatively injected intravenous 1mg/kg ketamine</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>We did not include a placebo group.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Kihwa Lee</name_or_title>
      <organization>Haeundae Paik Hospital, Inje University</organization>
      <phone>82-51-797-0426</phone>
      <email>tedy333@paik.ac.kr</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02256358
org study id: 2012-127
nct id: NCT02256358
lead sponsor: 
has dmc: No
Compare the effects of intravenous midazolam and ketamine on emergence agitation after
      sevoflurane anesthesia
Emergence agitation is self-limiting aggressive behavior that develops in the early period of
      awakening from anesthesia. A high level of preoperative anxiety is a risk factor for
      emergence agitation using Aono's four-point scale. Midazolam and ketamine was administered to
      the patients to decrease of preoperative anxiety. We aimed to compare the emergence agitation
      between midazolam group and ketamine group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Emergence Agitation
time frame: During 30 minutes after extubation at post-anesthetic care unit, every 5 minutes
description: The primary endpoint is the incidence of postoperative emergence agitation that was defined as an Aono's four-point scale(AFPS) score of 3 or higher.
arm group label: Midazolam
arm group type: Active Comparator
description: Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room.
arm group label: Ketamine
arm group type: Experimental
description: Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.
intervention type: Drug
intervention name: Midazolam
description: preoperatively injected intravenous 0.1 mg/kg midazolam
arm group label: Midazolam
intervention type: Drug
intervention name: Ketamine
description: Preoperatively injected intravenous 1mg/kg ketamine
arm group label: Ketamine
other name: Ketamine HCl
criteria: 
gender: All
minimum age: 2 Years
maximum age: 6 Years
healthy volunteers: No
last name: Kihwa Lee, MD
role: Study Chair
affiliation: Haeundae paik hospital, inje university
responsible party type: Principal Investigator
investigator affiliation: Inje University
investigator full name: Ki Hwa Lee
investigator title: Assistant professor
mesh term: Psychomotor Agitation
mesh term: Emergence Delirium
mesh term: Midazolam
mesh term: Ketamine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: We did not include a placebo group.
point of contact: 