<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/NCT02186132</url>
  </required_header>
  <id_info>
    <org_study_id>Si158/2012</org_study_id>
    <nct_id>NCT02186132</nct_id>
  </id_info>
  <brief_title>0.6 vs. 1.2 mg Atropine Together With Neostigmine 2.5 mg on Heart Rate in Patient Receiving Muscle Relaxant</brief_title>
  <official_title>The Effect of 0.6 vs. 1.2 Milligram Atropine Together With Neostigmine 2.5 Milligram on Heart Rate in Patient Receiving Muscle Relaxant During General Anesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mahidol University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mahidol University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Balanced general anesthesia with neuromuscular blocking agents has been widely used for&#xD;
      surgery.. At the end of surgery, neostigmine has been given for the reversal of neuromuscular&#xD;
      blocking agents with several adverse effects such as bradycardia and profuse secretion.&#xD;
      Atropine has been used to prevent those side effects of neostigmine. The routine dosages of&#xD;
      the two drugs are 2.5 mg of neostigmine and 1.2 mg of atropine.&#xD;
&#xD;
      Tribuddharat S ey al. (1) has demonstrated that after giving 0.9 mg atropine together with&#xD;
      2.5 mg of neostigmine the mean heart rate during 1-8 minutes after the administration was&#xD;
      increase 2-26 beats/min (bpm). At 9 and 10 minutes after administration of the drugs, the&#xD;
      mean heart rate were decrease 0.9 and 1.6 bpm In the control group which receiving 1.2 mg of&#xD;
      atropine, the mean heart rate during 1-10 minutes after administration was increase 4-32 bpm.&#xD;
      However this study did not report the incidence of bradycardia and blood pressure. The mean&#xD;
      heart rate prior to atropine and neostigmine was 74.43 + 11.82 bpm.(1)&#xD;
&#xD;
      Salem MG et al. (2) has demonstrated that after receiving 1.2 mg of atropine and 5 mg of&#xD;
      neostigmine the mean heart rate during 2-110 minutes was decrease 5-29 bpm with the lowest&#xD;
      heart rate at 40 minutes after administration. This study also did not report the blood&#xD;
      pressure.&#xD;
&#xD;
      The baseline heart rate (HR) before administration of the reversal was associated with the&#xD;
      following heart rate. Heinonen J et al. (3) has demonstrated that 80% of the patients after&#xD;
      receiving 0.015 mg/kg of atropine 3 minutes before 0.03 mg of neostigmine for the reversal of&#xD;
      pancuronium experienced bradycardia (heart rate &lt; 50 bpm) compared with none in patients&#xD;
      receiving alcuronium. However, before administration of atropine and neostigmine, the mean&#xD;
      heart rate of patients was significantly lower in the pancuronium group.&#xD;
&#xD;
      Either tachycardia or bradycardia with hypotension causes adverse affect to patient&#xD;
      especially in specific group like patient with coronary artery disease or undergoing&#xD;
      craniotomy.&#xD;
&#xD;
      The primary objective of our study is to demonstrate the effect on heart rate (HR) and blood&#xD;
      pressure of 0.6 mg atropine and 2.5 mg neostigmine for the reversal of muscle relaxant&#xD;
      compare to 1.2 mg atropine.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>heart rate</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>bradycardia</measure>
    <time_frame>24 hours</time_frame>
    <description>heart rate &lt; 60 beats/min</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Bradycardia</condition>
  <condition>Neostigmine Adverse Reaction</condition>
  <condition>Adverse Reaction to Belladonna or Atropine</condition>
  <arm_group>
    <arm_group_label>Atropine 0.6 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Atropine 0.6 mg intravenous</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Atropine 1.2 mg intravenous</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Atropine 1.2 mg intravenous</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atropine 0.6 mg</intervention_name>
    <description>Atropine 0.6 mg intravenous</description>
    <arm_group_label>Atropine 0.6 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atropine 1.2 mg</intervention_name>
    <description>Atropine 1.2 mg intravenous</description>
    <arm_group_label>Atropine 1.2 mg intravenous</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA physical status 1-3&#xD;
&#xD;
          -  age = or &gt; 18 years&#xD;
&#xD;
          -  patient receiving neuromuscular blocking agent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  baseline heart rate before administration of the study drugs &lt; 65 bpm&#xD;
&#xD;
          -  history of allergy to the study drugs&#xD;
&#xD;
          -  patient receiving either of the following drugs include beta-blockers, calcium channel&#xD;
             blocker, amiodarone or digoxin&#xD;
&#xD;
          -  history of complete heart block or second degree AV block.&#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>Sirilak Suksompong, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mahidol University</affiliation>
  </overall_official>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>July 7, 2014</last_update_submitted>
  <last_update_submitted_qc>July 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 10, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>heart rate</keyword>
  <keyword>neostigmine</keyword>
  <keyword>atropine</keyword>
  <keyword>dosage</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Hypotonia</mesh_term>
    <mesh_term>Bradycardia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atropine</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/NCT02186132
org study id: Si158/2012
nct id: NCT02186132
lead sponsor: 
has dmc: No
Balanced general anesthesia with neuromuscular blocking agents has been widely used for
      surgery.. At the end of surgery, neostigmine has been given for the reversal of neuromuscular
      blocking agents with several adverse effects such as bradycardia and profuse secretion.
      Atropine has been used to prevent those side effects of neostigmine. The routine dosages of
      the two drugs are 2.5 mg of neostigmine and 1.2 mg of atropine.

      Tribuddharat S ey al. (1) has demonstrated that after giving 0.9 mg atropine together with
      2.5 mg of neostigmine the mean heart rate during 1-8 minutes after the administration was
      increase 2-26 beats/min (bpm). At 9 and 10 minutes after administration of the drugs, the
      mean heart rate were decrease 0.9 and 1.6 bpm In the control group which receiving 1.2 mg of
      atropine, the mean heart rate during 1-10 minutes after administration was increase 4-32 bpm.
      However this study did not report the incidence of bradycardia and blood pressure. The mean
      heart rate prior to atropine and neostigmine was 74.43 + 11.82 bpm.(1)

      Salem MG et al. (2) has demonstrated that after receiving 1.2 mg of atropine and 5 mg of
      neostigmine the mean heart rate during 2-110 minutes was decrease 5-29 bpm with the lowest
      heart rate at 40 minutes after administration. This study also did not report the blood
      pressure.

      The baseline heart rate (HR) before administration of the reversal was associated with the
      following heart rate. Heinonen J et al. (3) has demonstrated that 80% of the patients after
      receiving 0.015 mg/kg of atropine 3 minutes before 0.03 mg of neostigmine for the reversal of
      pancuronium experienced bradycardia (heart rate < 50 bpm) compared with none in patients
      receiving alcuronium. However, before administration of atropine and neostigmine, the mean
      heart rate of patients was significantly lower in the pancuronium group.

      Either tachycardia or bradycardia with hypotension causes adverse affect to patient
      especially in specific group like patient with coronary artery disease or undergoing
      craniotomy.

      The primary objective of our study is to demonstrate the effect on heart rate (HR) and blood
      pressure of 0.6 mg atropine and 2.5 mg neostigmine for the reversal of muscle relaxant
      compare to 1.2 mg atropine.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: heart rate
time frame: 24 hours
measure: bradycardia
time frame: 24 hours
description: heart rate < 60 beats/min
arm group label: Atropine 0.6 mg
arm group type: Experimental
description: Atropine 0.6 mg intravenous
arm group label: Atropine 1.2 mg intravenous
arm group type: Active Comparator
description: Atropine 1.2 mg intravenous
intervention type: Drug
intervention name: Atropine 0.6 mg
description: Atropine 0.6 mg intravenous
arm group label: Atropine 0.6 mg
intervention type: Drug
intervention name: Atropine 1.2 mg
description: Atropine 1.2 mg intravenous
arm group label: Atropine 1.2 mg intravenous
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sirilak Suksompong, MD
role: Principal Investigator
affiliation: Mahidol University
responsible party type: Sponsor
mesh term: Muscle Hypotonia
mesh term: Bradycardia
mesh term: Atropine