<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/NCT03232125</url>
  </required_header>
  <id_info>
    <org_study_id>4-2017-0487</org_study_id>
    <nct_id>NCT03232125</nct_id>
  </id_info>
  <brief_title>Effect of Ramosetron on Heart Rate-corrected QT Interval During Robot-assisted Laparoscopic Prostatectomy With Steep Trendelenburg Position</brief_title>
  <official_title>Effect of Ramosetron on Heart Rate-corrected QT Interval During Robot-assisted Laparoscopic Prostatectomy With Steep Trendelenburg Position</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</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>
      Intraperitoneal insufflation of carbon dioxide may affect the sympathetic activity that leads&#xD;
      to changes in ventricular re-polarization. This in turn can result in changes of heart&#xD;
      rate-corrected QT (QTc) interval. Ramosetron is a 5-hydroxytryptamine three receptor&#xD;
      antagonist and widely used anti-emetics. However, QTc interval prolongation has been observed&#xD;
      in a number of patients after administration of 5-HT3 receptor antagonists. The aim of this&#xD;
      study is to evaluate the effects of ramosetron on QTc interval and possible cardiovascular&#xD;
      adverse effects during robot-assisted laparoscopic prostatectomy with steep Trendelenburg&#xD;
      position.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intraperitoneal insufflation of carbon dioxide may affect the sympathetic activity that leads&#xD;
      to changes in ventricular re-polarization. This in turn can result in changes of heart&#xD;
      rate-corrected QT (QTc) interval. Ramosetron is a 5-hydroxytryptamine three receptor&#xD;
      antagonist and widely used anti-emetics. However, QTc interval prolongation has been observed&#xD;
      in a number of patients after administration of 5-HT3 receptor antagonists. The aim of this&#xD;
      study is to evaluate the effects of ramosetron on QTc interval and possible cardiovascular&#xD;
      adverse effects during robot-assisted laparoscopic prostatectomy with steep Trendelenburg&#xD;
      position. Fifty-six patients, aged more than 19 years, undergoing robot-assisted laparoscopic&#xD;
      prostatectomy will be divided into ramosetron group (n=28) and control group (n=28). Randomly&#xD;
      selected patients of the ramoseton group are given a 0.3 mg of ramosetron after induction. In&#xD;
      contrast, patients in the control group are given the same volume of normal saline after&#xD;
      induction and given a 0.3 mg of ramosetron after measurement of QTc interval. The primary&#xD;
      endpoint is the difference in maximal change of QTc interval between groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">June 12, 2020</completion_date>
  <primary_completion_date type="Actual">June 9, 2020</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>Randomly selected patients of the ramoseton group are given a 0.3 mg of ramosetron after induction. In contrast, patients in the control group are given the same volume of normal saline after induction and given a 0.3 mg of ramosetron after measurement of QTc interval.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>Participants, care provider and investigator are blinded to group assignment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum change of QTc interval</measure>
    <time_frame>Before induction of anesthesia in the supine position (Baseline)</time_frame>
    <description>Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum change of QTc interval</measure>
    <time_frame>10 minutes after tracheal intubation (Intu-10 min.)</time_frame>
    <description>Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum change of QTc interval</measure>
    <time_frame>immediately after steep Trendelenburg position with CO2 pneumoperitoneum (T-on)</time_frame>
    <description>Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum change of QTc interval</measure>
    <time_frame>30 minutes after steep Trendelenburg position with CO2 pneumoperitoneum (T-30 min)</time_frame>
    <description>Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum change of QTc interval</measure>
    <time_frame>60 minutes after steep Trendelenburg position with CO2 pneumoperitoneum (T-60 min)</time_frame>
    <description>Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum change of QTc interval</measure>
    <time_frame>90 minutes after steep Trendelenburg position with CO2 pneumoperitoneum (T-90 min)</time_frame>
    <description>Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum change of QTc interval</measure>
    <time_frame>immediately after a supine position with CO2 desufflation (T-off)</time_frame>
    <description>Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum change of QTc interval</measure>
    <time_frame>at the end of surgery (Surgery end)</time_frame>
    <description>Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Ramosetron group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Randomly selected patients of the ramoseton group are given a 0.3 mg of ramosetron after induction.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>In contrast, patients in the control group are given the same volume of normal saline after induction and given a 0.3 mg of ramosetron after measurement of QTc interval.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ramosetron</intervention_name>
    <description>Randomly selected patients of the ramoseton group are given a 0.3 mg of ramosetron after induction.</description>
    <arm_group_label>Ramosetron group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline</intervention_name>
    <description>In contrast, patients in the control group are given the same volume of normal saline after induction and given a 0.3 mg of ramosetron after measurement of QTc interval.</description>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing robot-assisted laparoscopic prostatectomy&#xD;
&#xD;
          -  Age more than 19 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Preoperative electrocardiography (ECG) abnormalities, including a QTc interval of &gt;500&#xD;
             ms, ventricular conduction abnormalities, or arrhythmias&#xD;
&#xD;
          -  History of cardiac disease such as pacemaker insertion, unstable angina&#xD;
&#xD;
          -  Use of antiarrhythmic agents or medications that are known to prolong the QTc interval&#xD;
&#xD;
          -  Abnormal levels of preoperative serum electrolyte&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Professor, Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <results_reference>
    <citation>Kim TK, Cho YJ, Lim CW, Min JJ, Choi EK, Hong DM, Jeon Y. Effect of ramosetron on QTc interval: a randomised controlled trial in patients undergoing off-pump coronary artery bypass surgery. BMC Anesthesiol. 2016 Aug 3;16(1):56. doi: 10.1186/s12871-016-0222-1.</citation>
    <PMID>27488394</PMID>
  </results_reference>
  <results_reference>
    <citation>Lee JH, Yoo EK, Song IK, Kim JT, Kim HS. Effect of ramosetron on the QT interval during sevoflurane anaesthesia in children: a prospective observational study. Eur J Anaesthesiol. 2015 May;32(5):330-5. doi: 10.1097/EJA.0000000000000200.</citation>
    <PMID>25485883</PMID>
  </results_reference>
  <results_reference>
    <citation>Kim SH, Lee SM, Kim YK, Park SY, Lee JH, Cho SH, Chai WS, Jin HC. Effects of prophylactic ramosetron and ondansetron on corrected QT interval during general anesthesia. J Clin Anesth. 2014 Nov;26(7):511-6. doi: 10.1016/j.jclinane.2014.02.011. Epub 2014 Oct 18.</citation>
    <PMID>25439413</PMID>
  </results_reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>August 23, 2020</last_update_submitted>
  <last_update_submitted_qc>August 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ramosetron</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03232125
org study id: 4-2017-0487
nct id: NCT03232125
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Intraperitoneal insufflation of carbon dioxide may affect the sympathetic activity that leads
      to changes in ventricular re-polarization. This in turn can result in changes of heart
      rate-corrected QT (QTc) interval. Ramosetron is a 5-hydroxytryptamine three receptor
      antagonist and widely used anti-emetics. However, QTc interval prolongation has been observed
      in a number of patients after administration of 5-HT3 receptor antagonists. The aim of this
      study is to evaluate the effects of ramosetron on QTc interval and possible cardiovascular
      adverse effects during robot-assisted laparoscopic prostatectomy with steep Trendelenburg
      position.
Intraperitoneal insufflation of carbon dioxide may affect the sympathetic activity that leads
      to changes in ventricular re-polarization. This in turn can result in changes of heart
      rate-corrected QT (QTc) interval. Ramosetron is a 5-hydroxytryptamine three receptor
      antagonist and widely used anti-emetics. However, QTc interval prolongation has been observed
      in a number of patients after administration of 5-HT3 receptor antagonists. The aim of this
      study is to evaluate the effects of ramosetron on QTc interval and possible cardiovascular
      adverse effects during robot-assisted laparoscopic prostatectomy with steep Trendelenburg
      position. Fifty-six patients, aged more than 19 years, undergoing robot-assisted laparoscopic
      prostatectomy will be divided into ramosetron group (n=28) and control group (n=28). Randomly
      selected patients of the ramoseton group are given a 0.3 mg of ramosetron after induction. In
      contrast, patients in the control group are given the same volume of normal saline after
      induction and given a 0.3 mg of ramosetron after measurement of QTc interval. The primary
      endpoint is the difference in maximal change of QTc interval between groups.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomly selected patients of the ramoseton group are given a 0.3 mg of ramosetron after induction. In contrast, patients in the control group are given the same volume of normal saline after induction and given a 0.3 mg of ramosetron after measurement of QTc interval.
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
masking description: Participants, care provider and investigator are blinded to group assignment.
measure: Maximum change of QTc interval
time frame: Before induction of anesthesia in the supine position (Baseline)
description: Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.
measure: Maximum change of QTc interval
time frame: 10 minutes after tracheal intubation (Intu-10 min.)
description: Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.
measure: Maximum change of QTc interval
time frame: immediately after steep Trendelenburg position with CO2 pneumoperitoneum (T-on)
description: Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.
measure: Maximum change of QTc interval
time frame: 30 minutes after steep Trendelenburg position with CO2 pneumoperitoneum (T-30 min)
description: Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.
measure: Maximum change of QTc interval
time frame: 60 minutes after steep Trendelenburg position with CO2 pneumoperitoneum (T-60 min)
description: Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.
measure: Maximum change of QTc interval
time frame: 90 minutes after steep Trendelenburg position with CO2 pneumoperitoneum (T-90 min)
description: Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.
measure: Maximum change of QTc interval
time frame: immediately after a supine position with CO2 desufflation (T-off)
description: Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.
measure: Maximum change of QTc interval
time frame: at the end of surgery (Surgery end)
description: Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.
arm group label: Ramosetron group
arm group type: Experimental
description: Randomly selected patients of the ramoseton group are given a 0.3 mg of ramosetron after induction.
arm group label: Placebo group
arm group type: Placebo Comparator
description: In contrast, patients in the control group are given the same volume of normal saline after induction and given a 0.3 mg of ramosetron after measurement of QTc interval.
intervention type: Drug
intervention name: Ramosetron
description: Randomly selected patients of the ramoseton group are given a 0.3 mg of ramosetron after induction.
arm group label: Ramosetron group
intervention type: Drug
intervention name: Normal saline
description: In contrast, patients in the control group are given the same volume of normal saline after induction and given a 0.3 mg of ramosetron after measurement of QTc interval.
arm group label: Placebo group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
citation: Kim TK, Cho YJ, Lim CW, Min JJ, Choi EK, Hong DM, Jeon Y. Effect of ramosetron on QTc interval: a randomised controlled trial in patients undergoing off-pump coronary artery bypass surgery. BMC Anesthesiol. 2016 Aug 3;16(1):56. doi: 10.1186/s12871-016-0222-1.
PMID: 27488394
citation: Lee JH, Yoo EK, Song IK, Kim JT, Kim HS. Effect of ramosetron on the QT interval during sevoflurane anaesthesia in children: a prospective observational study. Eur J Anaesthesiol. 2015 May;32(5):330-5. doi: 10.1097/EJA.0000000000000200.
PMID: 25485883
citation: Kim SH, Lee SM, Kim YK, Park SY, Lee JH, Cho SH, Chai WS, Jin HC. Effects of prophylactic ramosetron and ondansetron on corrected QT interval during general anesthesia. J Clin Anesth. 2014 Nov;26(7):511-6. doi: 10.1016/j.jclinane.2014.02.011. Epub 2014 Oct 18.
PMID: 25439413
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Ramosetron
sharing ipd: No