<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/NCT02997800</url>
  </required_header>
  <id_info>
    <org_study_id>ANAE-219-12</org_study_id>
    <nct_id>NCT02997800</nct_id>
  </id_info>
  <brief_title>The Effect of Intraoperative Labetalol on Time to Discharge</brief_title>
  <official_title>The Effect of Intraoperative Labetalol on Time to Discharge and Hemodynamic Stability in Laparoscopic Cholecystectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr. Robert Tanzola</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Queen's University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients coming for surgery often receive opioid medications, like fentanyl, to treat pain.&#xD;
      Opioids however have many unpleasant side effects including nausea and vomiting, itching,&#xD;
      sedation, and decreased breathing. During laparoscopic surgery increases in heart and blood&#xD;
      pressure are often attributed to pain. It has been shown that by treating these changes with&#xD;
      medications such as esmolol, instead of opioids, side effects and time to discharge from&#xD;
      hospital can be reduced. Labetalol is a drug that is similar to esmolol but may have&#xD;
      advantages over it. It is more effective at controlling both heart rate and blood pressure&#xD;
      and it is easier and less costly to use. This study is investigating labetalol in patients&#xD;
      having laparoscopic gallbladder surgery and comparing it to esmolol and fentanyl. Patients&#xD;
      will be treated with one of these drugs during surgery to control heart rate and blood&#xD;
      pressure and the effects on time to discharge, pain scores, frequency of side effects, and&#xD;
      narcotic requirements will be observed in the recovery room. It is thought that labetalol&#xD;
      will be shown to be as effective as esmolol and that both drugs that minimize fentanyl will&#xD;
      show reduced time to discharge, fewer side effects, and effective treatment of heart rate and&#xD;
      blood pressure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">January 2019</completion_date>
  <primary_completion_date type="Actual">January 2019</primary_completion_date>
  <phase>Phase 2</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Length of stay in the post-anesthesia care unit (PACU)</measure>
    <time_frame>The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).</time_frame>
    <description>time from arrival in PACU after surgery until discharge from PACU</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intraoperative Heart Rate (HR)</measure>
    <time_frame>intraoperatively-from anesthesia induction to the surgery completion (wound closure) -approximately 45 min.</time_frame>
    <description>heart rate (beats per min.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative mean arterial pressure (MAP)</measure>
    <time_frame>intraoperatively-from anesthesia induction to the surgery completion (wound closure)-approximately 45 min.</time_frame>
    <description>blood pressure (mmHg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postoperative nausea and vomiting (PONV) in PACU</measure>
    <time_frame>The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).</time_frame>
    <description>incidence of nausea and vomiting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain scores</measure>
    <time_frame>The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).</time_frame>
    <description>pain scores visual analogue scale (VAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fentanyl required</measure>
    <time_frame>The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).</time_frame>
    <description>total fentanyl required mcg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adverse effects</measure>
    <time_frame>The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).</time_frame>
    <description>Any reported adverse effects or complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postoperative heart rate</measure>
    <time_frame>The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).</time_frame>
    <description>heart rate (beats per min)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postoperative mean arterial pressure (MAP)</measure>
    <time_frame>The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).</time_frame>
    <description>blood pressure (mmHg)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">172</enrollment>
  <condition>Bloodpressure</condition>
  <condition>Heart Rate</condition>
  <arm_group>
    <arm_group_label>Esmolol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Esmolol infusion and 1 ml saline infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Labetalol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Labetalol Bolus and saline infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fentanyl</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Fentanyl Bolus and saline infusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Esmolol</intervention_name>
    <description>Following induction and intubation, any increase in heart rate (HR) or mean arterial pressure (MAP) &gt;20% of baseline will be treated with an initial intravenous bolus of esmolol 30 mg IV (30 mg in 5 ml of normal saline). An intravenous esmolol infusion will be initiated at 5mcg/kg/min after the first intravenous bolus dose and will be titrated up by 5mcg/kg/min each time HR or MAP &gt;20% of baseline. An intravenous bolus of placebo (normal saline 1 ml) will be administered whenever a change to the infusion rate is made.</description>
    <arm_group_label>Esmolol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Labetalol</intervention_name>
    <description>Following induction and intubation, any increase in heart rate (HR) or mean arterial pressure (MAP) &gt;20% of baseline will be treated with an initial intravenous bolus of labetalol 10 mg IV (10 mg in 5 ml of normal saline). Any further increases in HR or MAP &gt;20% of baseline will be treated with intravenous boluses of labetalol 5 mg in 1 ml every 5 minutes as needed. An intravenous placebo infusion (normal saline) will be initiated at 5 mcg/kg/min after the first intravenous bolus dose and will be titrated up by 5 mcg/kg/min each time an additional intravenous bolus is given.</description>
    <arm_group_label>Labetalol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fentanyl</intervention_name>
    <description>Following induction and intubation, any increase in heart rate (HR) or mean arterial pressure (MAP) &gt;20% of baseline will be treated with an initial intravenous bolus of fentanyl 50 mcg IV (50 mcg in 5 ml of normal saline). Any further increases in HR or MAP &gt;20% of baseline will be treated with intravenous boluses of fentanyl 25 mcg in 1 ml every 5 minutes as needed. An intravenous placebo infusion (normal saline) will be initiated at 5 mcg/kg/min after the first intravenous bolus dose and will be titrated up by 5 mcg/kg/min each time an additional intravenous bolus is given.</description>
    <arm_group_label>Fentanyl</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>saline infusion</intervention_name>
    <description>An intravenous placebo infusion (normal saline) will be initiated at 5 mcg/kg/min after the first intravenous bolus drug dose (fentanyl or labetalol depending upon randomization) and will be titrated up by 5 mcg/kg/min each time an additional intravenous bolus is given.</description>
    <arm_group_label>Fentanyl</arm_group_label>
    <arm_group_label>Labetalol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>1 ml saline infusion</intervention_name>
    <description>Every time the infusion rate of esmolol is changed, 1 ml of normal saline will be infused.</description>
    <arm_group_label>Esmolol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  scheduled to undergo elective ambulatory laparoscopic cholecystectomy under general&#xD;
             anesthesia&#xD;
&#xD;
          -  American Society of Anesthesiologist's Status ASA) 1-3&#xD;
&#xD;
          -  able to understand and sign informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known allergy to any of the study medications including beta blockers, fentanyl,&#xD;
             acetaminophen, non-steroidal anti-inflammatories or local anesthetics&#xD;
&#xD;
          -  chronic use of beta-adrenergic receptor antagonists or opioids&#xD;
&#xD;
          -  conversion to open cholecystectomy&#xD;
&#xD;
          -  History of renal, hepatic or cardiac failure, reactive airway disease&#xD;
&#xD;
          -  Medical history that in the investigator's judgement would interfere with the protocol&#xD;
             or assessments&#xD;
&#xD;
          -  Unable to understand pain assessment&#xD;
&#xD;
          -  Failure to give informed consent&#xD;
&#xD;
          -  pregnant or breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Tanzola, MD, FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Queen's University-Anesthesiology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Queen's University, Department of Anesthesiology</name>
      <address>
        <city>Kingston</city>
        <state>Ontario</state>
        <zip>K7L 2V7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>February 11, 2020</last_update_submitted>
  <last_update_submitted_qc>February 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Queen's University</investigator_affiliation>
    <investigator_full_name>Dr. Robert Tanzola</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Labetalol</mesh_term>
    <mesh_term>Fentanyl</mesh_term>
    <mesh_term>Esmolol</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/NCT02997800
org study id: ANAE-219-12
nct id: NCT02997800
lead sponsor: 
has dmc: No
Patients coming for surgery often receive opioid medications, like fentanyl, to treat pain.
      Opioids however have many unpleasant side effects including nausea and vomiting, itching,
      sedation, and decreased breathing. During laparoscopic surgery increases in heart and blood
      pressure are often attributed to pain. It has been shown that by treating these changes with
      medications such as esmolol, instead of opioids, side effects and time to discharge from
      hospital can be reduced. Labetalol is a drug that is similar to esmolol but may have
      advantages over it. It is more effective at controlling both heart rate and blood pressure
      and it is easier and less costly to use. This study is investigating labetalol in patients
      having laparoscopic gallbladder surgery and comparing it to esmolol and fentanyl. Patients
      will be treated with one of these drugs during surgery to control heart rate and blood
      pressure and the effects on time to discharge, pain scores, frequency of side effects, and
      narcotic requirements will be observed in the recovery room. It is thought that labetalol
      will be shown to be as effective as esmolol and that both drugs that minimize fentanyl will
      show reduced time to discharge, fewer side effects, and effective treatment of heart rate and
      blood pressure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Length of stay in the post-anesthesia care unit (PACU)
time frame: The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).
description: time from arrival in PACU after surgery until discharge from PACU
measure: Intraoperative Heart Rate (HR)
time frame: intraoperatively-from anesthesia induction to the surgery completion (wound closure) -approximately 45 min.
description: heart rate (beats per min.)
measure: Intraoperative mean arterial pressure (MAP)
time frame: intraoperatively-from anesthesia induction to the surgery completion (wound closure)-approximately 45 min.
description: blood pressure (mmHg)
measure: postoperative nausea and vomiting (PONV) in PACU
time frame: The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).
description: incidence of nausea and vomiting
measure: pain scores
time frame: The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).
description: pain scores visual analogue scale (VAS)
measure: fentanyl required
time frame: The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).
description: total fentanyl required mcg
measure: adverse effects
time frame: The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).
description: Any reported adverse effects or complications
measure: postoperative heart rate
time frame: The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).
description: heart rate (beats per min)
measure: postoperative mean arterial pressure (MAP)
time frame: The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).
description: blood pressure (mmHg)
arm group label: Esmolol
arm group type: Experimental
description: Esmolol infusion and 1 ml saline infusion
arm group label: Labetalol
arm group type: Experimental
description: Labetalol Bolus and saline infusion
arm group label: Fentanyl
arm group type: Active Comparator
description: Fentanyl Bolus and saline infusion
intervention type: Drug
intervention name: Esmolol
description: Following induction and intubation, any increase in heart rate (HR) or mean arterial pressure (MAP) >20% of baseline will be treated with an initial intravenous bolus of esmolol 30 mg IV (30 mg in 5 ml of normal saline). An intravenous esmolol infusion will be initiated at 5mcg/kg/min after the first intravenous bolus dose and will be titrated up by 5mcg/kg/min each time HR or MAP >20% of baseline. An intravenous bolus of placebo (normal saline 1 ml) will be administered whenever a change to the infusion rate is made.
arm group label: Esmolol
intervention type: Drug
intervention name: Labetalol
description: Following induction and intubation, any increase in heart rate (HR) or mean arterial pressure (MAP) >20% of baseline will be treated with an initial intravenous bolus of labetalol 10 mg IV (10 mg in 5 ml of normal saline). Any further increases in HR or MAP >20% of baseline will be treated with intravenous boluses of labetalol 5 mg in 1 ml every 5 minutes as needed. An intravenous placebo infusion (normal saline) will be initiated at 5 mcg/kg/min after the first intravenous bolus dose and will be titrated up by 5 mcg/kg/min each time an additional intravenous bolus is given.
arm group label: Labetalol
intervention type: Drug
intervention name: Fentanyl
description: Following induction and intubation, any increase in heart rate (HR) or mean arterial pressure (MAP) >20% of baseline will be treated with an initial intravenous bolus of fentanyl 50 mcg IV (50 mcg in 5 ml of normal saline). Any further increases in HR or MAP >20% of baseline will be treated with intravenous boluses of fentanyl 25 mcg in 1 ml every 5 minutes as needed. An intravenous placebo infusion (normal saline) will be initiated at 5 mcg/kg/min after the first intravenous bolus dose and will be titrated up by 5 mcg/kg/min each time an additional intravenous bolus is given.
arm group label: Fentanyl
intervention type: Other
intervention name: saline infusion
description: An intravenous placebo infusion (normal saline) will be initiated at 5 mcg/kg/min after the first intravenous bolus drug dose (fentanyl or labetalol depending upon randomization) and will be titrated up by 5 mcg/kg/min each time an additional intravenous bolus is given.
arm group label: Fentanyl
arm group label: Labetalol
intervention type: Other
intervention name: 1 ml saline infusion
description: Every time the infusion rate of esmolol is changed, 1 ml of normal saline will be infused.
arm group label: Esmolol
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Robert Tanzola, MD, FRCPC
role: Principal Investigator
affiliation: Queen's University-Anesthesiology
facility: 
country: Canada
responsible party type: Sponsor-Investigator
investigator affiliation: Queen's University
investigator full name: Dr. Robert Tanzola
investigator title: Principal Investigator
mesh term: Labetalol
mesh term: Fentanyl
mesh term: Esmolol