<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/NCT02213848</url>
  </required_header>
  <id_info>
    <org_study_id>Calcium RNMB</org_study_id>
    <nct_id>NCT02213848</nct_id>
  </id_info>
  <brief_title>Effect of Calcium Chloride on Recovery From Neuromuscular Blockade</brief_title>
  <official_title>Effect of Calcium Chloride on Recovery From Neuromuscular Blockade in Patients Undergoing General Anesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effect of calcium chloride against residual&#xD;
      neuromuscular blockade at the end of general anesthesia&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During general anesthesia, neuromuscular blocking agent is administered to facilitate&#xD;
      endotracheal intubation and the view of operative field. The neuromuscular blockade should be&#xD;
      reversed at the end of anesthesia to recover spontaneous breathing of the patient.&#xD;
&#xD;
      Residual neuromuscular blockade (RNMB) is defined as train of-four ratio &lt; 0.9. RNMB is a&#xD;
      risk factor for postoperative pulmonary complication and increases postoperative mortality.&#xD;
      Neostigmine is acetylcholinesterase inhibitor routinely used at the end of anesthesia to&#xD;
      prevent RNMB. A meta-analysis, however, showed that 40 percent of patients who received&#xD;
      intermediate-acting neuromuscular blocking agent during anesthesia showed RNMB in PACU.&#xD;
&#xD;
      Calcium triggers the release of acetylcholine from the motor nerve terminal and enhances&#xD;
      excitation-contraction coupling in muscle. Increasing calcium concentrations decreased the&#xD;
      sensitivity to dTc and pancuronium in an animal muscle-nerve model. The effect of calcium&#xD;
      chloride on residual neuromuscular blockade is not studied yet.&#xD;
&#xD;
      The purpose of this study is to evaluate the effect of calcium chloride on residual&#xD;
      neuromuscular blockade at the end of general anesthesia&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to train of-four ratio of 0.9.</measure>
    <time_frame>At 10 minutes (expected aeverage) after the surgery</time_frame>
    <description>Train of-four will be measured using acceleromyograph.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Train of-four ratio</measure>
    <time_frame>At 5, 10, 20 minutes after the administration of reversal drug</time_frame>
    <description>Train of-four will be measured using accelerography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of PACU stay</measure>
    <time_frame>At 60 minutes (expected average) after the surgery</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Residual Neuromuscular Blockade</condition>
  <arm_group>
    <arm_group_label>Calcium</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administration of calcium chloride 5 mg/kg along with neostigmine 25 mcg/kg + atropine 15 mcg/kg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>In the control group, all the procedures were the same with calcium group, except for the fact that calcium chloride is not administered</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Calcium</intervention_name>
    <description>Administration of calcium chloride 5 mg/kg along with neostigmine 25 mcg/kg + atropine 15 mcg/kg</description>
    <arm_group_label>Calcium</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>control</intervention_name>
    <description>In the control group, all the procedures were the same with calcium group, except for the fact that calcium chloride is not administered</description>
    <arm_group_label>control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-65 yr&#xD;
&#xD;
          -  Body mass index 15.0-25.0 kg/m2&#xD;
&#xD;
          -  American Society of Anesthesiologists physical status I-III&#xD;
&#xD;
          -  Scheduled for elective surgery with an expected duration of more than 60 min under&#xD;
             general anesthesia with endotracheal intubation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Suspected difficulty airway&#xD;
&#xD;
          -  Bronchial asthma, chronic obstructive pulmonary disease&#xD;
&#xD;
          -  Neuromuscular disease&#xD;
&#xD;
          -  Hepatic or renal dysfunction.&#xD;
&#xD;
          -  Taking medications that might influence the effect of neuromuscular blocking agents&#xD;
&#xD;
          -  Allergy to the medication that used in this trial&#xD;
&#xD;
          -  Pregnant, or breastfeeding state&#xD;
&#xD;
          -  Suspected malignant hyperthermia&#xD;
&#xD;
          -  Contraindication to the medication that used in this trial&#xD;
&#xD;
          -  Hypercalcemia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hyun Chang Kim, M.D., Ph. D.</last_name>
    <role>Study Director</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jae Woo Ju, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>June 29, 2015</last_update_submitted>
  <last_update_submitted_qc>June 29, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 30, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Deok Man Hong</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Neuromuscular blockade reversal</keyword>
  <keyword>TOF ratio</keyword>
  <keyword>Calcium chloride</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delayed Emergence from Anesthesia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcium</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02213848
org study id: Calcium RNMB
nct id: NCT02213848
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the effect of calcium chloride against residual
      neuromuscular blockade at the end of general anesthesia
During general anesthesia, neuromuscular blocking agent is administered to facilitate
      endotracheal intubation and the view of operative field. The neuromuscular blockade should be
      reversed at the end of anesthesia to recover spontaneous breathing of the patient.

      Residual neuromuscular blockade (RNMB) is defined as train of-four ratio < 0.9. RNMB is a
      risk factor for postoperative pulmonary complication and increases postoperative mortality.
      Neostigmine is acetylcholinesterase inhibitor routinely used at the end of anesthesia to
      prevent RNMB. A meta-analysis, however, showed that 40 percent of patients who received
      intermediate-acting neuromuscular blocking agent during anesthesia showed RNMB in PACU.

      Calcium triggers the release of acetylcholine from the motor nerve terminal and enhances
      excitation-contraction coupling in muscle. Increasing calcium concentrations decreased the
      sensitivity to dTc and pancuronium in an animal muscle-nerve model. The effect of calcium
      chloride on residual neuromuscular blockade is not studied yet.

      The purpose of this study is to evaluate the effect of calcium chloride on residual
      neuromuscular blockade at the end of general anesthesia
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Time to train of-four ratio of 0.9.
time frame: At 10 minutes (expected aeverage) after the surgery
description: Train of-four will be measured using acceleromyograph.
measure: Train of-four ratio
time frame: At 5, 10, 20 minutes after the administration of reversal drug
description: Train of-four will be measured using accelerography.
measure: Length of PACU stay
time frame: At 60 minutes (expected average) after the surgery
arm group label: Calcium
arm group type: Experimental
description: Administration of calcium chloride 5 mg/kg along with neostigmine 25 mcg/kg + atropine 15 mcg/kg
arm group label: control
arm group type: Placebo Comparator
description: In the control group, all the procedures were the same with calcium group, except for the fact that calcium chloride is not administered
intervention type: Drug
intervention name: Calcium
description: Administration of calcium chloride 5 mg/kg along with neostigmine 25 mcg/kg + atropine 15 mcg/kg
arm group label: Calcium
intervention type: Drug
intervention name: control
description: In the control group, all the procedures were the same with calcium group, except for the fact that calcium chloride is not administered
arm group label: control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Hyun Chang Kim, M.D., Ph. D.
role: Study Director
affiliation: Seoul National University Hospital
last name: Jae Woo Ju, M.D.
role: Study Director
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Deok Man Hong
investigator title: Associate Professor
mesh term: Delayed Emergence from Anesthesia
mesh term: Calcium