<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/NCT01709422</url>
  </required_header>
  <id_info>
    <org_study_id>1774906506805161</org_study_id>
    <nct_id>NCT01709422</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety Profiles of Combination Sedation Propofol With Midazolam and Meperidine.</brief_title>
  <acronym>ERCP</acronym>
  <official_title>Efficacy and Safety Profiles of Sedation With Propofol Combined With Intravenous Midazolam and Meperidine Versus Intravenous Midazolam and Meperidine for Ambulatory Endoscopic Retrograde-cholangiopancreatography(ERCP).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prince of Songkla University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Prince of Songkla University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare efficacy and safety of combination of propofol and&#xD;
      midazolam with meperidine versus midazolam and meperidine for ambulatory ERCP&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      ERCP is commonly done under sedation with midazolam and meperidine, however some studies&#xD;
      showed varying outcomes of this conventional sedation for maintained sedation. Propofol is&#xD;
      increasing used for sedation in gastrointestinal procedure owing to its rapid recovery&#xD;
      profiles but the complications associated with propofol are not negligible.The investigators&#xD;
      prospectively compare the efficacy, induction time, recovery time, patient satisfaction and&#xD;
      side effect between propofol based and conventional sedations in patients undergoing ERCP.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2010</start_date>
  <completion_date type="Actual">November 2012</completion_date>
  <primary_completion_date type="Actual">November 2012</primary_completion_date>
  <phase>Phase 4</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Procedure Related Time</measure>
    <time_frame>participants will be followed for the duration of procedure, an expected average of 2.0 hours ]</time_frame>
    <description>(1) induction time ( the time from sedation to scope intubation ), (2) procedure time ( the time from scope intubation to scope withdrawal ) and (3) recovery time ( the time from scope withdrawal to full recovery ).The induction time, procedural time and recovery time were recorded by the nurse in the endoscopy unit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular Adverse Events.</measure>
    <time_frame>participants will be followed for the duration of procedure, an expected average of 2.0 hours</time_frame>
    <description>(1) desaturation(oxygen saturation &lt; 90 % at least 10 second ) (2) hypotension ( systolic blood pressure &lt; 90 mmHg or dropped more than 25 % of baseline ) (3)bradycardia (heart rate &lt; 50 beats/min) and (4) apnea ( cessation of respiratory activity for over 10 seconds ). When patients developed oxygen saturation &lt; 90 %, then nasal oxygen was administered, If patients not able to recover from oxygen therapy and tactile stimulations thus the procedure was terminated. The procedure was terminated if patients developed serious adverse event as heart rate below 5 beats/min and or apnea.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Disorders of Gallbladder, Biliary Tract and Pancrease</condition>
  <arm_group>
    <arm_group_label>Propofol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>both midazolam (1mg if aged &lt;= 70 years or 0.5mg in age &gt;70 years) and meperidine 20 mg were given intravenously at the initiation of sedation, Thereafter, an initial bolus of propofol 20 mg intravenously. Sedation was maintained with repeated dose of 5 to 10 mg propofol.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>both midazolam 2 to 5 mg and meperidine 25 to 50 mg were given intravenously at the initiation of sedation. Sedation was maintained with repeated doses of 0.5 to 1.0 mg midazolam and 5 to 10 mg meperidine.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol</intervention_name>
    <description>Propofol is the sedative drug used as an additional sedation to one of the study arm.</description>
    <arm_group_label>Propofol</arm_group_label>
    <other_name>Diprivan</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Midazolam</intervention_name>
    <description>Midazolam is one of the two conventional sedative drugs included in both arms.</description>
    <arm_group_label>Conventional</arm_group_label>
    <arm_group_label>Propofol</arm_group_label>
    <other_name>Benzodiazepine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Meperidine</intervention_name>
    <description>Meperidine is one of the two conventional sedative drugs included in both arms.</description>
    <arm_group_label>Conventional</arm_group_label>
    <arm_group_label>Propofol</arm_group_label>
    <other_name>Pethidine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        . All outpatients aged more than 18 years who were schedule for ERCP -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant woman&#xD;
&#xD;
          -  emergency situation ( i.e. concomitant upper gastrointestinal bleeding, acute&#xD;
             cholangitis )&#xD;
&#xD;
          -  American Society of Anesthesiologist ( ASA )Class IV or V&#xD;
&#xD;
          -  respiratory disease,&#xD;
&#xD;
          -  sleep apnea&#xD;
&#xD;
          -  allergy to egg or soybean&#xD;
&#xD;
          -  drug abuse( benzodiazepine, opioid agonist )&#xD;
&#xD;
          -  previous history of failure sedation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nisa Netinatsunton, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NKC Institute of Gastroenterology and Hepatology, Prince of Songklanakarind University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nisa Netinatsunton, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Prince of Songkla University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NKC Institues of Gastroenterology and Hepatology, Prince of Songkla University</name>
      <address>
        <city>Hatyai</city>
        <state>Songkhla</state>
        <zip>90110</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <link>
    <url>http://www.nkc-psu.org</url>
    <description>Prince of Songkhla University</description>
  </link>
  <verification_date>September 2013</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <results_first_submitted>November 30, 2012</results_first_submitted>
  <results_first_submitted_qc>August 24, 2013</results_first_submitted_qc>
  <results_first_posted type="Estimate">August 27, 2013</results_first_posted>
  <last_update_submitted>September 12, 2013</last_update_submitted>
  <last_update_submitted_qc>September 12, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 22, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Prince of Songkla University</investigator_affiliation>
    <investigator_full_name>Nisa Netinatsunton</investigator_full_name>
    <investigator_title>NKC Institute of Gastroenterology and Hepatology</investigator_title>
  </responsible_party>
  <keyword>Propofol</keyword>
  <keyword>Midazolam</keyword>
  <keyword>Meperidine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gallbladder Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Midazolam</mesh_term>
    <mesh_term>Meperidine</mesh_term>
    <mesh_term>Propofol</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Patients who were schedule for endoscopic retrograde cholangiopancreatography in NKC Institute ,Prince of Songkla University during January 2010-December 2011</recruitment_details>
      <pre_assignment_details>Patients were excluded from the final analysis if the procedure was terminated due to technical reasons prior to attempted cannulation.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Propofol</title>
          <description>The propofol was given as initial bolus of 20 mg and then the dose was given 5-10 mg every 30-60 second.the dose of midazolam was 1 mg in patients below 70 years and 0.5 mg in patients ≥ 70 years and the dose of meperidine was fixed at 20 mg.</description>
        </group>
        <group group_id="P2">
          <title>Conventional</title>
          <description>The initial dose of midazolam and meperidine were 2-5 mg iv and 25-50 mg iv respectively then the midazolam dose was given 0.5-1.0 mg iv and meperidine dose was given 5-10 mg iv every 2-3 minutes</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="70"/>
                <participants group_id="P2" count="70"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="70"/>
                <participants group_id="P2" count="70"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Propofol,Midazolam and Meperidine</title>
          <description>The propofol was given as initial bolus of 20 mg and then the dose was given 5-10 mg every 30-60 second.the dose of midazolam was 1 mg in patients below 70 years and 0.5 mg in patients ≥ 70 years and the dose of meperidine was fixed at 20 mg.</description>
        </group>
        <group group_id="B2">
          <title>Midazolam and Meperidine</title>
          <description>The initial dose of midazolam and meperidine were 2-5 mg iv and 25-50 mg iv respectively then the midazolam dose was given 0.5-1.0 mg iv and meperidine dose was given 5-10 mg iv every 2-3 minutes</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="70"/>
            <count group_id="B2" value="70"/>
            <count group_id="B3" value="140"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="84"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55.77" spread="17.35"/>
                    <measurement group_id="B2" value="61.31" spread="16.52"/>
                    <measurement group_id="B3" value="58.54" spread="17.11"/>
                  </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="38"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="72"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Thailand</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                    <measurement group_id="B2" value="70"/>
                    <measurement group_id="B3" value="140"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Secondary</type>
        <title>Cardiovascular Adverse Events.</title>
        <description>(1) desaturation(oxygen saturation &lt; 90 % at least 10 second ) (2) hypotension ( systolic blood pressure &lt; 90 mmHg or dropped more than 25 % of baseline ) (3)bradycardia (heart rate &lt; 50 beats/min) and (4) apnea ( cessation of respiratory activity for over 10 seconds ). When patients developed oxygen saturation &lt; 90 %, then nasal oxygen was administered, If patients not able to recover from oxygen therapy and tactile stimulations thus the procedure was terminated. The procedure was terminated if patients developed serious adverse event as heart rate below 5 beats/min and or apnea.</description>
        <time_frame>participants will be followed for the duration of procedure, an expected average of 2.0 hours</time_frame>
        <population>Intention to treat population include participants who received sedative agents and underwent ERCP.</population>
        <group_list>
          <group group_id="O1">
            <title>Propofol,Midazolam and Meperidine</title>
            <description>the dose of midazolam was 1 mg in patients below 70 years and 0.5 mg in patients ≥ 70 years and the dose of meperidine was fixed at 20 mg. The propofol was given as initial bolus of 20 mg and then the dose was given 5-10 mg every 30-60 second to maintained the desired level of sedation(moderate to deep sedation ) without maximum limit.</description>
          </group>
          <group group_id="O2">
            <title>Midazolam and Meperidine</title>
            <description>the initial dose of midazolam and meperidine were 2-5 mg iv and 25-50 mg iv respectively then the midazolam dose was given 0.5-1.0 mg iv and meperidine dose was given 5-10 mg iv every 2-3 minutes to maintain the desired level of sedation(moderate to deep sedation ) without maximum limit.</description>
          </group>
        </group_list>
        <measure>
          <title>Cardiovascular Adverse Events.</title>
          <description>(1) desaturation(oxygen saturation &lt; 90 % at least 10 second ) (2) hypotension ( systolic blood pressure &lt; 90 mmHg or dropped more than 25 % of baseline ) (3)bradycardia (heart rate &lt; 50 beats/min) and (4) apnea ( cessation of respiratory activity for over 10 seconds ). When patients developed oxygen saturation &lt; 90 %, then nasal oxygen was administered, If patients not able to recover from oxygen therapy and tactile stimulations thus the procedure was terminated. The procedure was terminated if patients developed serious adverse event as heart rate below 5 beats/min and or apnea.</description>
          <population>Intention to treat population include participants who received sedative agents and underwent ERCP.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participants with desatuartion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with hypotension</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with bradycardia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.05</p_value>
            <method>Chi-squared</method>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>0.2</param_value>
            <ci_percent>95</ci_percent>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Procedure Related Time</title>
        <description>(1) induction time ( the time from sedation to scope intubation ), (2) procedure time ( the time from scope intubation to scope withdrawal ) and (3) recovery time ( the time from scope withdrawal to full recovery ).The induction time, procedural time and recovery time were recorded by the nurse in the endoscopy unit.</description>
        <time_frame>participants will be followed for the duration of procedure, an expected average of 2.0 hours ]</time_frame>
        <population>Intention to treat population include participants who received sedative agents and underwent endoscopic retrograde cholangiopancreatography(ERCP).</population>
        <group_list>
          <group group_id="O1">
            <title>Propofol,Midazolam and Meperidine</title>
            <description>the dose of midazolam was 1 mg in patients below 70 years and 0.5 mg in patients ≥ 70 years and the dose of meperidine was fixed at 20 mg. The propofol was given as initial bolus of 20 mg and then the dose was given 5-10 mg every 30-60 second to maintained the desired level of sedation (moderate to deep sedation ) without maximum limit</description>
          </group>
          <group group_id="O2">
            <title>Midazolam and Meperidine</title>
            <description>the initial dose of midazolam and meperidine were 2-5 mg iv and 25-50 mg iv respectively then the midazolam dose was given 0.5-1.0 mg iv and meperidine dose was given 5-10 mg iv every 2-3minutes to maintain the desired level of sedation (moderate to deep sedation ) without maximum limit.</description>
          </group>
        </group_list>
        <measure>
          <title>Procedure Related Time</title>
          <description>(1) induction time ( the time from sedation to scope intubation ), (2) procedure time ( the time from scope intubation to scope withdrawal ) and (3) recovery time ( the time from scope withdrawal to full recovery ).The induction time, procedural time and recovery time were recorded by the nurse in the endoscopy unit.</description>
          <population>Intention to treat population include participants who received sedative agents and underwent endoscopic retrograde cholangiopancreatography(ERCP).</population>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>procedure time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.67" spread="27.50"/>
                    <measurement group_id="O2" value="43.24" spread="31.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>induction time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.94" spread="2.18"/>
                    <measurement group_id="O2" value="5.47" spread="2.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>recovery time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.71" spread="23.03"/>
                    <measurement group_id="O2" value="88.50" spread="54.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.05</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>28</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 month</time_frame>
      <desc>ERCP complications and sedation related complications are assessed one month after the procedure date.</desc>
      <group_list>
        <group group_id="E1">
          <title>Propofol,Midazolam and Meperidine</title>
          <description>The propofol was given as initial bolus of 20 mg and then the dose was given 5-10 mg every 30-60 second.the dose of midazolam was 1 mg in patients below 70 years and 0.5 mg in patients ≥ 70 years and the dose of meperidine was fixed at 20 mg.</description>
        </group>
        <group group_id="E2">
          <title>Midazolam and Meperidine</title>
          <description>The initial dose of midazolam and meperidine were 2-5 mg iv and 25-50 mg iv respectively then the midazolam dose was given 0.5-1.0 mg iv and meperidine dose was given 5-10 mg iv every 2-3 minutes</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>ERCP complications</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Severe bradycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>ERCP complications</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="40" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="26" subjects_affected="26" subjects_at_risk="70"/>
                <counts group_id="E2" events="40" subjects_affected="40" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>
    <point_of_contact>
      <name_or_title>Dr. Nisa Netinatsunton</name_or_title>
      <organization>Prince of Songkhla University</organization>
      <phone>6674451965 ext 9</phone>
      <email>nisasan@yahoo.com</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/NCT01709422
org study id: 1774906506805161
nct id: NCT01709422
lead sponsor: 
has dmc: Yes
The purpose of this study is to compare efficacy and safety of combination of propofol and
      midazolam with meperidine versus midazolam and meperidine for ambulatory ERCP
ERCP is commonly done under sedation with midazolam and meperidine, however some studies
      showed varying outcomes of this conventional sedation for maintained sedation. Propofol is
      increasing used for sedation in gastrointestinal procedure owing to its rapid recovery
      profiles but the complications associated with propofol are not negligible.The investigators
      prospectively compare the efficacy, induction time, recovery time, patient satisfaction and
      side effect between propofol based and conventional sedations in patients undergoing ERCP.
allocation: Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: Procedure Related Time
time frame: participants will be followed for the duration of procedure, an expected average of 2.0 hours ]
description: (1) induction time ( the time from sedation to scope intubation ), (2) procedure time ( the time from scope intubation to scope withdrawal ) and (3) recovery time ( the time from scope withdrawal to full recovery ).The induction time, procedural time and recovery time were recorded by the nurse in the endoscopy unit.
measure: Cardiovascular Adverse Events.
time frame: participants will be followed for the duration of procedure, an expected average of 2.0 hours
description: (1) desaturation(oxygen saturation < 90 % at least 10 second ) (2) hypotension ( systolic blood pressure < 90 mmHg or dropped more than 25 % of baseline ) (3)bradycardia (heart rate < 50 beats/min) and (4) apnea ( cessation of respiratory activity for over 10 seconds ). When patients developed oxygen saturation < 90 %, then nasal oxygen was administered, If patients not able to recover from oxygen therapy and tactile stimulations thus the procedure was terminated. The procedure was terminated if patients developed serious adverse event as heart rate below 5 beats/min and or apnea.
arm group label: Propofol
arm group type: Active Comparator
description: both midazolam (1mg if aged <= 70 years or 0.5mg in age >70 years) and meperidine 20 mg were given intravenously at the initiation of sedation, Thereafter, an initial bolus of propofol 20 mg intravenously. Sedation was maintained with repeated dose of 5 to 10 mg propofol.
arm group label: Conventional
arm group type: Active Comparator
description: both midazolam 2 to 5 mg and meperidine 25 to 50 mg were given intravenously at the initiation of sedation. Sedation was maintained with repeated doses of 0.5 to 1.0 mg midazolam and 5 to 10 mg meperidine.
intervention type: Drug
intervention name: Propofol
description: Propofol is the sedative drug used as an additional sedation to one of the study arm.
arm group label: Propofol
other name: Diprivan
intervention type: Drug
intervention name: Midazolam
description: Midazolam is one of the two conventional sedative drugs included in both arms.
arm group label: Conventional
arm group label: Propofol
other name: Benzodiazepine
intervention type: Drug
intervention name: Meperidine
description: Meperidine is one of the two conventional sedative drugs included in both arms.
arm group label: Conventional
arm group label: Propofol
other name: Pethidine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Nisa Netinatsunton, MD
role: Principal Investigator
affiliation: NKC Institute of Gastroenterology and Hepatology, Prince of Songklanakarind University
last name: Nisa Netinatsunton, MD
role: Principal Investigator
affiliation: Prince of Songkla University
facility: 
country: Thailand
url: http://www.nkc-psu.org
description: Prince of Songkhla University
responsible party type: Principal Investigator
investigator affiliation: Prince of Songkla University
investigator full name: Nisa Netinatsunton
investigator title: NKC Institute of Gastroenterology and Hepatology
mesh term: Gallbladder Diseases
mesh term: Midazolam
mesh term: Meperidine
mesh term: Propofol
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 