xml: <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/NCT05997004</url>
    </required_header>
    <id_info>
      <org_study_id>NAMS Nepal</org_study_id>
      <nct_id>NCT05997004</nct_id>
    </id_info>
    <brief_title>Glycopyrrolate Prophylaxis for Prevention of Bradyarrhythmia During Laparoscopic Cholecystectomy</brief_title>
    <official_title>Glycopyrrolate Prophylaxis for Prevention of Bradyarrhythmia During Laparoscopic Cholecystectomy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Academy of Medical Sciences, Nepal</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Academy of Medical Sciences, Nepal</source>
    <oversight_info>
      <has_dmc>Yes</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>
        The goal of this clinical trial is to evaluate the incidence of bradycardia during&#xD;
        laparoscopic cholecystectomy. The main question[s] it aims to answer are:&#xD;
  &#xD;
          -  Does bradycardia really occurs during pneumoperitoneum/laparoscopic surgery?&#xD;
  &#xD;
          -  If the patient get Glycopyrrolate, Does it really prevent pneumoperitoneum/laparoscopic&#xD;
             surgery induced bradycardia?&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The emergence of laparoscopic surgery has changed the way of approach for several organs.&#xD;
        Despite several advantages, laparoscopic surgery may result in serious complications due to&#xD;
        the physiologic changes which occur during the procedure. The cardiovascular system is one of&#xD;
        the most challenged systems of the human body during laparoscopy. The insufflation of gas&#xD;
        into the peritoneal cavity can provoke arrhythmias. Their incidence is as high as 14-27% of&#xD;
        laparoscopies which is higher than in 'open' surgery. The life-threatening bradyarrhythmia&#xD;
        (sinus bradycardia, nodal rhythm, atrio-ventricular dissociation and asystole) are frequently&#xD;
        encountered during laparoscopic procedure which are due to a vagal-mediated cardiovascular&#xD;
        reflex initiated by rapid stretching of the peritoneum at the beginning of peritoneal&#xD;
        insufflation. There are studies addressing measures to prevent or control cardiovascular&#xD;
        catastrophes during laparoscopic cholecystectomy. Some studies suggest administration of&#xD;
        anticholinergic agents especially glycopyrrolate and atropine for prevention of bradycardia&#xD;
        during intra-abdominal laparoscopic surgeries. Whereas some study suggests judicious use of&#xD;
        Atropine as it increases the risk of tachyarrhythmia. Glycopyrrolate is a synthetic&#xD;
        anticholinergic commonly used as a preoperative antimuscarinic agent to reduce salivary,&#xD;
        tracheobronchial, and pharyngeal secretions, to reduce the volume and free acidity of gastric&#xD;
        secretions, and to block cardiac vagal inhibitory reflexes during induction of anesthesia and&#xD;
        intubation.&#xD;
  &#xD;
        HYPOTHESIS Glycopyrrolate administration reduces the incidence of bradycardia during&#xD;
        Laparoscopic Cholecystectomy.&#xD;
  &#xD;
        General objectives To evaluate the role of Glycopyrrolate on prevention of bradyarrhythmia&#xD;
        during Laparoscopic cholecystectomy.&#xD;
  &#xD;
        Specific objective&#xD;
  &#xD;
          1. To evaluate the change in heart rate and rhythm at different time interval after&#xD;
             pneumoperitoneum.&#xD;
  &#xD;
          2. To evaluate the change in Systolic, diastolic and Mean arterial blood pressure at&#xD;
             different time interval after pneumoperitoneum.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">May 1, 2018</start_date>
    <completion_date type="Actual">November 15, 2019</completion_date>
    <primary_completion_date type="Actual">May 20, 2019</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>
      <intervention_model_description>Patients were randomly assigned to two groups having 31 in each, by using a computer-generated table of random numbers which was enclosed in a sealed envelope and was opened by an anesthesiologist who were not involved in the study.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Heart Rate (Bradycardia)</measure>
      <time_frame>Starting at 1minutes after creation of pneumoperitoneum up to Extubation (Recorded at 1,3,5,10,20,30,40,50 minutes after pneumoperitoneum and before and after extubation)</time_frame>
      <description>The primary outcome will be Bradycardia defined as heart rate below 60beats per minute</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Systolic Blood Pressure</measure>
      <time_frame>Starting at 1minutes after creation of pneumoperitoneum up to Extubation (Recorded at 1,3,5,10,20,30,40,50 minutes after pneumoperitoneum and before and after extubation)</time_frame>
      <description>Monitoring of systolic Blood pressure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Diastolic Blood Pressure</measure>
      <time_frame>Starting at 1minutes after creation of pneumoperitoneum up to Extubation (Recorded at 1,3,5,10,20,30,40,50 minutes after pneumoperitoneum and before and after extubation)</time_frame>
      <description>Monitoring of diastolic Blood pressure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean Arterial Pressure</measure>
      <time_frame>Starting at 1minutes after creation of pneumoperitoneum up to Extubation (Recorded at 1,3,5,10,20,30,40,50 minutes after pneumoperitoneum and before and after extubation)</time_frame>
      <description>Monitoring of Mean Arteria pressure</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">62</enrollment>
    <condition>Bradyarrhythmia</condition>
    <condition>Cardiac Arrest</condition>
    <condition>Tachycardia</condition>
    <condition>Asystole</condition>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>31 participants received 1ml of Normal Saline</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Glyco</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>31 participants received 1ml (0.2mg) of Glycopyrrolate</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Normal Saline</intervention_name>
      <description>After surgical creation of umbilical port Control group received injection normal saline 1ml.</description>
      <arm_group_label>Control</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Glycopyrrolate</intervention_name>
      <description>After surgical creation of umbilical port Group II received injection Glycopyrrolate 1ml=0.2mg</description>
      <arm_group_label>Glyco</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Adult patients of either sex aged 15-65 years&#xD;
  &#xD;
            2. Patient undergoing elective laparoscopic cholecystectomy&#xD;
  &#xD;
            3. American Society of Anesthesiologists (ASA) physical status I&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients with history of recent or past cardiac diseases&#xD;
  &#xD;
            2. Patients with pre-operative heart rate ≤60beats/min.&#xD;
  &#xD;
            3. Patients on cardiac medications&#xD;
  &#xD;
            4. Allergic to Glycopyrrolate&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Brihaspati K C, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>NAMS Bir Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Brahmadev Jha, MD</last_name>
      <role>Study Chair</role>
      <affiliation>NAMS Bir Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Surendra Bhusal, MD</last_name>
      <role>Study Chair</role>
      <affiliation>NAMS Bir Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>National Academy of Medical Sciences</name>
        <address>
          <city>Kathmandu</city>
          <country>Nepal</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Nepal</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>National Academy of Medical Sciences, Nepal</investigator_affiliation>
      <investigator_full_name>Brihaspati K C</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Glycopyrrolate</keyword>
    <keyword>Bradyarrhythmia</keyword>
    <keyword>Laparoscopy</keyword>
    <keyword>Pneumoperitoneum</keyword>
    <keyword>Cardiac Arrest</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Arrest</mesh_term>
      <mesh_term>Tachycardia</mesh_term>
      <mesh_term>Bradycardia</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Glycopyrrolate</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05997004
  org study id: NAMS Nepal
  nct id: NCT05997004
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to evaluate the incidence of bradycardia during
        laparoscopic cholecystectomy. The main question[s] it aims to answer are:
  
          -  Does bradycardia really occurs during pneumoperitoneum/laparoscopic surgery?
  
          -  If the patient get Glycopyrrolate, Does it really prevent pneumoperitoneum/laparoscopic
             surgery induced bradycardia?
  The emergence of laparoscopic surgery has changed the way of approach for several organs.
        Despite several advantages, laparoscopic surgery may result in serious complications due to
        the physiologic changes which occur during the procedure. The cardiovascular system is one of
        the most challenged systems of the human body during laparoscopy. The insufflation of gas
        into the peritoneal cavity can provoke arrhythmias. Their incidence is as high as 14-27% of
        laparoscopies which is higher than in 'open' surgery. The life-threatening bradyarrhythmia
        (sinus bradycardia, nodal rhythm, atrio-ventricular dissociation and asystole) are frequently
        encountered during laparoscopic procedure which are due to a vagal-mediated cardiovascular
        reflex initiated by rapid stretching of the peritoneum at the beginning of peritoneal
        insufflation. There are studies addressing measures to prevent or control cardiovascular
        catastrophes during laparoscopic cholecystectomy. Some studies suggest administration of
        anticholinergic agents especially glycopyrrolate and atropine for prevention of bradycardia
        during intra-abdominal laparoscopic surgeries. Whereas some study suggests judicious use of
        Atropine as it increases the risk of tachyarrhythmia. Glycopyrrolate is a synthetic
        anticholinergic commonly used as a preoperative antimuscarinic agent to reduce salivary,
        tracheobronchial, and pharyngeal secretions, to reduce the volume and free acidity of gastric
        secretions, and to block cardiac vagal inhibitory reflexes during induction of anesthesia and
        intubation.
  
        HYPOTHESIS Glycopyrrolate administration reduces the incidence of bradycardia during
        Laparoscopic Cholecystectomy.
  
        General objectives To evaluate the role of Glycopyrrolate on prevention of bradyarrhythmia
        during Laparoscopic cholecystectomy.
  
        Specific objective
  
          1. To evaluate the change in heart rate and rhythm at different time interval after
             pneumoperitoneum.
  
          2. To evaluate the change in Systolic, diastolic and Mean arterial blood pressure at
             different time interval after pneumoperitoneum.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Patients were randomly assigned to two groups having 31 in each, by using a computer-generated table of random numbers which was enclosed in a sealed envelope and was opened by an anesthesiologist who were not involved in the study.
  primary purpose: Prevention
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Heart Rate (Bradycardia)
  time frame: Starting at 1minutes after creation of pneumoperitoneum up to Extubation (Recorded at 1,3,5,10,20,30,40,50 minutes after pneumoperitoneum and before and after extubation)
  description: The primary outcome will be Bradycardia defined as heart rate below 60beats per minute
  measure: Systolic Blood Pressure
  time frame: Starting at 1minutes after creation of pneumoperitoneum up to Extubation (Recorded at 1,3,5,10,20,30,40,50 minutes after pneumoperitoneum and before and after extubation)
  description: Monitoring of systolic Blood pressure
  measure: Diastolic Blood Pressure
  time frame: Starting at 1minutes after creation of pneumoperitoneum up to Extubation (Recorded at 1,3,5,10,20,30,40,50 minutes after pneumoperitoneum and before and after extubation)
  description: Monitoring of diastolic Blood pressure
  measure: Mean Arterial Pressure
  time frame: Starting at 1minutes after creation of pneumoperitoneum up to Extubation (Recorded at 1,3,5,10,20,30,40,50 minutes after pneumoperitoneum and before and after extubation)
  description: Monitoring of Mean Arteria pressure
  arm group label: Control
  arm group type: Placebo Comparator
  description: 31 participants received 1ml of Normal Saline
  arm group label: Glyco
  arm group type: Experimental
  description: 31 participants received 1ml (0.2mg) of Glycopyrrolate
  intervention type: Drug
  intervention name: Normal Saline
  description: After surgical creation of umbilical port Control group received injection normal saline 1ml.
  arm group label: Control
  intervention type: Drug
  intervention name: Glycopyrrolate
  description: After surgical creation of umbilical port Group II received injection Glycopyrrolate 1ml=0.2mg
  arm group label: Glyco
  criteria: 
  gender: All
  minimum age: 15 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Brihaspati K C, MD
  role: Principal Investigator
  affiliation: NAMS Bir Hospital
  last name: Brahmadev Jha, MD
  role: Study Chair
  affiliation: NAMS Bir Hospital
  last name: Surendra Bhusal, MD
  role: Study Chair
  affiliation: NAMS Bir Hospital
  facility: 
  country: Nepal
  responsible party type: Principal Investigator
  investigator affiliation: National Academy of Medical Sciences, Nepal
  investigator full name: Brihaspati K C
  investigator title: Principal Investigator
  mesh term: Heart Arrest
  mesh term: Tachycardia
  mesh term: Bradycardia
  mesh term: Glycopyrrolate