<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/NCT03791879</url>
  </required_header>
  <id_info>
    <org_study_id>MFM IR.18.11.322 - 2018/11/11</org_study_id>
    <nct_id>NCT03791879</nct_id>
  </id_info>
  <brief_title>Caudal Dexmedetomidine Analgesia in Pediatrics .</brief_title>
  <official_title>The Analgesic Effectiveness and Safety of Upgraded Caudal Dexmedetomidine Doses in Pediatric Hypospadias Surgery.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Dexmedetomidine (DEXM) is a highly selective α2-adrenoceptor agonist that has been used&#xD;
      increasingly in pediatric anesthesia. This prospective double blinded randomized comparative&#xD;
      study is designed to evaluate the analgesic effect of caudal increasing doses of DEXM 0.5 , 1&#xD;
      , 1.5 , 2µg/kg combined with Levobupivacaine (Levob) 0.125% (ED95% =125%=least effective&#xD;
      concentration) in providing pain relief over a 24-h period and lowest surgical stress peak.&#xD;
      Study hypothesis: Levobupivacaine 0.125 %( ED95) combined with different increasing doses of&#xD;
      dexamedatomedine &gt;1 µg/kg could not add more analgesic &amp; stress response obtundation outcome,&#xD;
      but increase side effects (sedation and hemodynamic depression). The peak cortisol level&#xD;
      during urology surgery was at the end of the 1st postoperative (PO) hour. Aim of the Study:&#xD;
      To detect the optimal analgesic and safe caudal adjuvant DEXM dose associated with the least&#xD;
      side effects&amp; stress response modulation, guided by PO Cortisol peak difference in between&#xD;
      the study groups during pediatric hypospadias surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Dexmedetomidine (DEXM) is a highly selective α2-adrenoceptor agonist that has&#xD;
      been used increasingly in pediatric anesthesia. This prospective double blinded randomized&#xD;
      comparative study is designed to evaluate the analgesic effect of caudal increasing doses of&#xD;
      DEXM 0.5 , 1 , 1.5 , 2µg/kg combined with Levobupivacaine (Levob) 0.125% (ED95% =125%=least&#xD;
      effective concentration) in providing pain relief over a 24-h period and lowest surgical&#xD;
      stress peak. Study hypothesis: Levobupivacaine 0.125 %( ED95) combined with different&#xD;
      increasing doses of dexamedatomedine &gt;1 µg/kg could not add more analgesic &amp; stress response&#xD;
      obtundation outcome, but increase side effects (sedation and hemodynamic depression).The peak&#xD;
      cortisol level during urology surgery was at the end of the 1st postoperative (PO) hour. Aim&#xD;
      of the Study: To detect the optimal analgesic and safe caudal adjuvant DEXM dose associated&#xD;
      with the least side effects&amp; stress response modulation, guided by PO Cortisol peak&#xD;
      difference in between the study groups during pediatric hypospadias surgery.&#xD;
&#xD;
      Optimal effective dose defined as; the least caudal DEXM dose which produce the best&#xD;
      analgesic outcome [least time to 1st analgesic request and lowest rescue analgesic dose&#xD;
      (24Hs)] associated with the least stress response (cortisol PO. first One hour peak), least&#xD;
      PO sedation, and hemodynamic stability IO. &amp;PO. HR &amp; MAP. The peak cortisol level during&#xD;
      urology surgery was at the end of the 1st postoperative (PO) hour.&#xD;
&#xD;
      . Material &amp; Methods A prospective randomized double blinded (drug injector and PO assessor)&#xD;
      comparative study will be conducted in Mansoura university hospital after obtaining ethics&#xD;
      committee approval and written informed parental consent 164 boys (age 1-6 years, ASA I)&#xD;
      scheduled for hypospadias surgery. Exclusion criteria; (Operative time exceeding 3 hours,&#xD;
      bodyweight &gt;25kg, bleeding diathesis, infection at the site of block, pre-existing&#xD;
      neurological or spinal disease or abnormalities of the sacrum, inability to palpate the&#xD;
      sacral hiatus by anatomic landmark palpation technique) or those with a history of allergic&#xD;
      reactions to local anesthetics were excluded from the study. Patients will fast for solids 6h&#xD;
      and water and 2 hours before surgery. After Patient Preoperative preparation, General&#xD;
      anesthesia induction, caudal block and caudal drug injection (Levob plus DEXM) bolus will be&#xD;
      injected according to each group as follow;&#xD;
&#xD;
        -  Group A will take Caudal Levob 0. 125%+ DEXM 0.5µg/kg.&#xD;
&#xD;
        -  Group B will take Caudal Levob 0.125%+ DEXM 1µg/kg.&#xD;
&#xD;
        -  Group C will take Caudal Levob 0. 125%+ DEXM 1.5 µg/kg.&#xD;
&#xD;
        -  Group D will take Caudal Levob 0. 125%+ DEXM 2µg/kg.&#xD;
&#xD;
      The study outcomes recording:&#xD;
&#xD;
      1ry outcome: Time to (1st analgesic request OPS &gt;4). Secondary outcome: Total 24hours PO.&#xD;
      Rescue analgesic dose IM pethidine 0.5mg/kg [2,3] based on local policy and protocol,&#xD;
      Patients demographic data [age, weight, end tidal Sevoflurane (volume %) prior starting skin&#xD;
      closure, intraoperative fentanyl total dose, recovery time (time from discontinuation of&#xD;
      anesthesia to spontaneous eye opening)], Serum Cortisol level at basal before anesthesia and&#xD;
      1hour postoperative in between groups [1] , Apnea incidence (NO&amp;%), and desaturation (NO&amp;%),&#xD;
      Objective pain score, Sedation score, Behavioral score for Agitation assessment, and Modified&#xD;
      bromage score (residual Lower limb muscle weakness) recorded every 15 minutes for 1st hour&#xD;
      then every 30 minutes for next 3 PO hours then at next 6th, 12th, 18th, 24th PO hours,&#xD;
      hemodynamics, HR&amp;SBP the incidence of bradycardia and hypotension per 50% percentile.&#xD;
      Recorded every 10 minutes IO for maximum operative time 3 hours and every 30 min PO for next&#xD;
      2h in the recovery room until the child was discharged to the ward.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">October 15, 2020</completion_date>
  <primary_completion_date type="Actual">October 1, 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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to (1st analgesic request objective pain score (OPS) ≥4)</measure>
    <time_frame>Basal (0) till 24 hours.</time_frame>
    <description>time from full recovery till child express moderate pain OPS 4 and ask for the first analgesic dose</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">164</enrollment>
  <condition>164 Boys for Hypospadias Surgery Under General Anesthesia With Caudal Block</condition>
  <arm_group>
    <arm_group_label>• Group A will take Caudal Levob 0. 125%+ DEXM 0.5µg/k</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>• Group B will take Caudal Levob 0.125%+ DEXM 1µg/kg.</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>• Group C will take Caudal Levob 0. 125%+ DEXM 1.5 µg/</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>• Group D will take Caudal Levob 0. 125%+ DEXM 2µg/kg.</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Caudal dexamedatomidine analgesia</intervention_name>
    <description>Technique performance (Caudal block): classical technique; palpation, identification and puncture with the patients in the lateral position (permits easy access to the airway under general anesthesia) using a 22-G short-beveled needle under sterile conditions advancing needle pierces the sacrococcygeal ligament.&#xD;
After needle insertion, pre-calculated volume of Levob plus DEXM bolus was injected as follow; Group A Caudal Levob 0.125%+ DEXM 0.5µg/kg. Group B Caudal Levob 0.125%+ DEXM 1µg/kg. Group C Caudal Levob 0.125%+ DEXM 1. 5 µg/kg. Group D Caudal Levob 0.125%+ DEXM 2µg/kg.</description>
    <arm_group_label>• Group A will take Caudal Levob 0. 125%+ DEXM 0.5µg/k</arm_group_label>
    <arm_group_label>• Group B will take Caudal Levob 0.125%+ DEXM 1µg/kg.</arm_group_label>
    <arm_group_label>• Group C will take Caudal Levob 0. 125%+ DEXM 1.5 µg/</arm_group_label>
    <arm_group_label>• Group D will take Caudal Levob 0. 125%+ DEXM 2µg/kg.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  164 boys (age 1-8 years, ASA I) scheduled for hypospadias surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Operative time exceeding 3 hours, bodyweight &gt;25kg, bleeding diathesis, infection at&#xD;
             the site of block, pre-existing neurological or spinal disease or abnormalities of the&#xD;
             sacrum, inability to palpate the sacral hiatus by anatomic landmark palpation&#xD;
             technique) or those with a history of allergic reactions to local anesthetics were&#xD;
             excluded from the study&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>mohamed A Ghanem, A professor</last_name>
    <role>Study Chair</role>
    <affiliation>Mansoura Univeristy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Anesthesia department,Faculty of medicine, Mansoura univerisety</name>
      <address>
        <city>Mansoura</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>December 29, 2018</study_first_submitted>
  <study_first_submitted_qc>December 31, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>February 26, 2021</last_update_submitted>
  <last_update_submitted_qc>February 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mansoura University</investigator_affiliation>
    <investigator_full_name>Mohamed Abd Latif Ghanim</investigator_full_name>
    <investigator_title>Associate Professor os anesthesia ICU &amp; Pain medicine.</investigator_title>
  </responsible_party>
  <keyword>Caudal</keyword>
  <keyword>Dexmedetomidine</keyword>
  <keyword>Levobupivacaine</keyword>
  <keyword>hypospadias</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypospadias</mesh_term>
  </condition_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/NCT03791879
org study id: MFM IR.18.11.322 - 2018/11/11
nct id: NCT03791879
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Dexmedetomidine (DEXM) is a highly selective α2-adrenoceptor agonist that has been used
      increasingly in pediatric anesthesia. This prospective double blinded randomized comparative
      study is designed to evaluate the analgesic effect of caudal increasing doses of DEXM 0.5 , 1
      , 1.5 , 2µg/kg combined with Levobupivacaine (Levob) 0.125% (ED95% =125%=least effective
      concentration) in providing pain relief over a 24-h period and lowest surgical stress peak.
      Study hypothesis: Levobupivacaine 0.125 %( ED95) combined with different increasing doses of
      dexamedatomedine >1 µg/kg could not add more analgesic & stress response obtundation outcome,
      but increase side effects (sedation and hemodynamic depression). The peak cortisol level
      during urology surgery was at the end of the 1st postoperative (PO) hour. Aim of the Study:
      To detect the optimal analgesic and safe caudal adjuvant DEXM dose associated with the least
      side effects& stress response modulation, guided by PO Cortisol peak difference in between
      the study groups during pediatric hypospadias surgery.
Background: Dexmedetomidine (DEXM) is a highly selective α2-adrenoceptor agonist that has
      been used increasingly in pediatric anesthesia. This prospective double blinded randomized
      comparative study is designed to evaluate the analgesic effect of caudal increasing doses of
      DEXM 0.5 , 1 , 1.5 , 2µg/kg combined with Levobupivacaine (Levob) 0.125% (ED95% =125%=least
      effective concentration) in providing pain relief over a 24-h period and lowest surgical
      stress peak. Study hypothesis: Levobupivacaine 0.125 %( ED95) combined with different
      increasing doses of dexamedatomedine >1 µg/kg could not add more analgesic & stress response
      obtundation outcome, but increase side effects (sedation and hemodynamic depression).The peak
      cortisol level during urology surgery was at the end of the 1st postoperative (PO) hour. Aim
      of the Study: To detect the optimal analgesic and safe caudal adjuvant DEXM dose associated
      with the least side effects& stress response modulation, guided by PO Cortisol peak
      difference in between the study groups during pediatric hypospadias surgery.

      Optimal effective dose defined as; the least caudal DEXM dose which produce the best
      analgesic outcome [least time to 1st analgesic request and lowest rescue analgesic dose
      (24Hs)] associated with the least stress response (cortisol PO. first One hour peak), least
      PO sedation, and hemodynamic stability IO. &PO. HR & MAP. The peak cortisol level during
      urology surgery was at the end of the 1st postoperative (PO) hour.

      . Material & Methods A prospective randomized double blinded (drug injector and PO assessor)
      comparative study will be conducted in Mansoura university hospital after obtaining ethics
      committee approval and written informed parental consent 164 boys (age 1-6 years, ASA I)
      scheduled for hypospadias surgery. Exclusion criteria; (Operative time exceeding 3 hours,
      bodyweight >25kg, bleeding diathesis, infection at the site of block, pre-existing
      neurological or spinal disease or abnormalities of the sacrum, inability to palpate the
      sacral hiatus by anatomic landmark palpation technique) or those with a history of allergic
      reactions to local anesthetics were excluded from the study. Patients will fast for solids 6h
      and water and 2 hours before surgery. After Patient Preoperative preparation, General
      anesthesia induction, caudal block and caudal drug injection (Levob plus DEXM) bolus will be
      injected according to each group as follow;

        -  Group A will take Caudal Levob 0. 125%+ DEXM 0.5µg/kg.

        -  Group B will take Caudal Levob 0.125%+ DEXM 1µg/kg.

        -  Group C will take Caudal Levob 0. 125%+ DEXM 1.5 µg/kg.

        -  Group D will take Caudal Levob 0. 125%+ DEXM 2µg/kg.

      The study outcomes recording:

      1ry outcome: Time to (1st analgesic request OPS >4). Secondary outcome: Total 24hours PO.
      Rescue analgesic dose IM pethidine 0.5mg/kg [2,3] based on local policy and protocol,
      Patients demographic data [age, weight, end tidal Sevoflurane (volume %) prior starting skin
      closure, intraoperative fentanyl total dose, recovery time (time from discontinuation of
      anesthesia to spontaneous eye opening)], Serum Cortisol level at basal before anesthesia and
      1hour postoperative in between groups [1] , Apnea incidence (NO&%), and desaturation (NO&%),
      Objective pain score, Sedation score, Behavioral score for Agitation assessment, and Modified
      bromage score (residual Lower limb muscle weakness) recorded every 15 minutes for 1st hour
      then every 30 minutes for next 3 PO hours then at next 6th, 12th, 18th, 24th PO hours,
      hemodynamics, HR&SBP the incidence of bradycardia and hypotension per 50% percentile.
      Recorded every 10 minutes IO for maximum operative time 3 hours and every 30 min PO for next
      2h in the recovery room until the child was discharged to the ward.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Time to (1st analgesic request objective pain score (OPS) ≥4)
time frame: Basal (0) till 24 hours.
description: time from full recovery till child express moderate pain OPS 4 and ask for the first analgesic dose
arm group label: • Group A will take Caudal Levob 0. 125%+ DEXM 0.5µg/k
arm group type: Active Comparator
arm group label: • Group B will take Caudal Levob 0.125%+ DEXM 1µg/kg.
arm group type: Active Comparator
arm group label: • Group C will take Caudal Levob 0. 125%+ DEXM 1.5 µg/
arm group type: Active Comparator
arm group label: • Group D will take Caudal Levob 0. 125%+ DEXM 2µg/kg.
arm group type: Active Comparator
intervention type: Drug
intervention name: Caudal dexamedatomidine analgesia
description: Technique performance (Caudal block): classical technique; palpation, identification and puncture with the patients in the lateral position (permits easy access to the airway under general anesthesia) using a 22-G short-beveled needle under sterile conditions advancing needle pierces the sacrococcygeal ligament.
After needle insertion, pre-calculated volume of Levob plus DEXM bolus was injected as follow; Group A Caudal Levob 0.125%+ DEXM 0.5µg/kg. Group B Caudal Levob 0.125%+ DEXM 1µg/kg. Group C Caudal Levob 0.125%+ DEXM 1. 5 µg/kg. Group D Caudal Levob 0.125%+ DEXM 2µg/kg.
arm group label: • Group A will take Caudal Levob 0. 125%+ DEXM 0.5µg/k
arm group label: • Group B will take Caudal Levob 0.125%+ DEXM 1µg/kg.
arm group label: • Group C will take Caudal Levob 0. 125%+ DEXM 1.5 µg/
arm group label: • Group D will take Caudal Levob 0. 125%+ DEXM 2µg/kg.
criteria: 
gender: Male
gender based: Yes
minimum age: 1 Year
maximum age: 8 Years
healthy volunteers: No
last name: mohamed A Ghanem, A professor
role: Study Chair
affiliation: Mansoura Univeristy
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Mansoura University
investigator full name: Mohamed Abd Latif Ghanim
investigator title: Associate Professor os anesthesia ICU & Pain medicine.
mesh term: Hypospadias