<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/NCT03261921</url>
  </required_header>
  <id_info>
    <org_study_id>N-43-2016</org_study_id>
    <nct_id>NCT03261921</nct_id>
  </id_info>
  <brief_title>Caudal Combination of Dexamethasone and/or Dexmedetomidine to Bupivacaine in Pediatric Hypospadias Surgery</brief_title>
  <official_title>Adjuncts to Caudal Block in Pediatrics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo 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>
      One of the most commonly used regional anesthetic techniques in pediatric surgeries is the&#xD;
      caudal epidural block. Its main disadvantage remains the short duration of action. Hence,&#xD;
      different additives have been used. Dexmedetomidine as an additive to the local anesthetic&#xD;
      bupivacaine in caudal epidural analgesia prolongs the duration of postoperative analgesia so&#xD;
      is dexamethasone. The investigators aimed to study the effect of combining both additives in&#xD;
      the duration of analgesia, decreasing side effects and decreasing anesthetic doses&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sixty three children scheduled for hypospadias randomized into 3 groups. Group I (n=21)&#xD;
      (dexamethasone 0.1mg/kg+ 0.5ml/kg bupivacaine 0.25%), group II(n=21)( dexmedetomidine&#xD;
      0.01ug/kg+ 0.5ml/kg bupivacaine 0.25%)and&#xD;
      groupIII(n=21)(dexamethasone0.1mg/kg+dexmedetomidine0.01ug/kg +0.5ml/kg bupivacaine&#xD;
      0.25%).intraoperative and postoperative hemodynamics were recorded. In PACU, MOPS scores and&#xD;
      sedation scores were recorded at 30min,1,2,3,6and 12hrs. Also the time of first analgesic&#xD;
      request was recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 5, 2016</start_date>
  <completion_date type="Actual">July 7, 2017</completion_date>
  <primary_completion_date type="Actual">June 22, 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <intervention_model_description>Sixty-three patients with ASA I-II aged from 1-6 years scheduled for hypospadias surgery in Abu El-Resh pediatric Hospital-Cairo university, were included in this prospective randomized double-blinded clinical study. Patients with contraindication to caudal anesthesia, cardiovascular diseases, drug allergy, type I diabetes, clotting disorders, mentally retarded children or those whose families did not approve inclusion in the study were excluded from the study.&#xD;
Patients were randomly divided on the morning of surgery into three groups group I( dexamethasone 21 patients), Group II ( Dexmedetomidine 21 patients) and group III(Dexmedetomidine and dexamethasone 21 patients).</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>The Patients allocated to study groups using computer generated random list &amp; group assignment was sealed in sequentially numbered opaque envelopes that opened after induction of anesthesia.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Time of first request of analgesia</measure>
    <time_frame>12 hours</time_frame>
    <description>the time from caudal block to the first time to analgesic needs</description>
  </primary_outcome>
  <primary_outcome>
    <measure>pain scores</measure>
    <time_frame>12 hours</time_frame>
    <description>the modified objective pain score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>sedation score</measure>
    <time_frame>12 hours</time_frame>
    <description>ramsay sedation score at the time of pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>heart rates(beat/minute)</measure>
    <time_frame>3 hours.</time_frame>
    <description>Intra-operative recording</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mean arterial pressure (mmhg)</measure>
    <time_frame>3 hours</time_frame>
    <description>Intra-operative recording</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>Caudal Block</condition>
  <arm_group>
    <arm_group_label>Dexamethasone group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this group the patients received 0.5 ml/kg of bupivacaine 0.25% + (0.1 mg/kg dexamethazone) caudally.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dexmedetomidine group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this group the Patients received 0.5 ml/kg of bupivacaine 0.25% + dexmedetomidine(1 mu/kg) caudally.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Combination group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this group the patients received 0.5 ml/kg of bupivacaine 0.25% + dexamethasone(0.1mg/kg) and dexmedetomidine (1 mu/kg) caudally.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>Dexamethasone is used peri -operatively mainly to prevent nausea and vomiting. Also epidural administration of dexamethasone prolong the postoperative analgesia and reduce analgesic needs</description>
    <arm_group_label>Combination group</arm_group_label>
    <arm_group_label>Dexamethasone group</arm_group_label>
    <other_name>decadron</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <description>Dexmedetomidine is an alpha 2 agonist which has sedative ,analgesic, opioid sparing effect and was proved to prolong the duration of postoperative analgesia when added to local anesthetics</description>
    <arm_group_label>Combination group</arm_group_label>
    <arm_group_label>Dexmedetomidine group</arm_group_label>
    <other_name>precedex</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <description>local anesthetic agent</description>
    <arm_group_label>Combination group</arm_group_label>
    <arm_group_label>Dexamethasone group</arm_group_label>
    <arm_group_label>Dexmedetomidine group</arm_group_label>
    <other_name>plain marcaine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1 - ASA I-II 2- Males only 3- Children aged from 1-6 years 4- Children scheduled for&#xD;
        hypospadias surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Contraindication to caudal anesthesia.&#xD;
&#xD;
          2. cardiovascular diseases.&#xD;
&#xD;
          3. drug allergy.&#xD;
&#xD;
          4. Type I diabetes.&#xD;
&#xD;
          5. Clotting disorders.&#xD;
&#xD;
          6. Mentally retarded children or those whose families did not approve inclusion in the&#xD;
             study&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>males candidate for hypospadias surgery</gender_description>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>August 22, 2017</last_update_submitted>
  <last_update_submitted_qc>August 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Amany Hassan Saleh</investigator_full_name>
    <investigator_title>principal investigator,MD of anesthesia and intensive care unit.</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Dexmedetomidine</mesh_term>
    <mesh_term>Bupivacaine</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/NCT03261921
org study id: N-43-2016
nct id: NCT03261921
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
One of the most commonly used regional anesthetic techniques in pediatric surgeries is the
      caudal epidural block. Its main disadvantage remains the short duration of action. Hence,
      different additives have been used. Dexmedetomidine as an additive to the local anesthetic
      bupivacaine in caudal epidural analgesia prolongs the duration of postoperative analgesia so
      is dexamethasone. The investigators aimed to study the effect of combining both additives in
      the duration of analgesia, decreasing side effects and decreasing anesthetic doses
Sixty three children scheduled for hypospadias randomized into 3 groups. Group I (n=21)
      (dexamethasone 0.1mg/kg+ 0.5ml/kg bupivacaine 0.25%), group II(n=21)( dexmedetomidine
      0.01ug/kg+ 0.5ml/kg bupivacaine 0.25%)and
      groupIII(n=21)(dexamethasone0.1mg/kg+dexmedetomidine0.01ug/kg +0.5ml/kg bupivacaine
      0.25%).intraoperative and postoperative hemodynamics were recorded. In PACU, MOPS scores and
      sedation scores were recorded at 30min,1,2,3,6and 12hrs. Also the time of first analgesic
      request was recorded.
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: Sixty-three patients with ASA I-II aged from 1-6 years scheduled for hypospadias surgery in Abu El-Resh pediatric Hospital-Cairo university, were included in this prospective randomized double-blinded clinical study. Patients with contraindication to caudal anesthesia, cardiovascular diseases, drug allergy, type I diabetes, clotting disorders, mentally retarded children or those whose families did not approve inclusion in the study were excluded from the study.
Patients were randomly divided on the morning of surgery into three groups group I( dexamethasone 21 patients), Group II ( Dexmedetomidine 21 patients) and group III(Dexmedetomidine and dexamethasone 21 patients).
primary purpose: Diagnostic
masking: Triple (Participant, Care Provider, Investigator)
masking description: The Patients allocated to study groups using computer generated random list & group assignment was sealed in sequentially numbered opaque envelopes that opened after induction of anesthesia.
measure: Time of first request of analgesia
time frame: 12 hours
description: the time from caudal block to the first time to analgesic needs
measure: pain scores
time frame: 12 hours
description: the modified objective pain score
measure: sedation score
time frame: 12 hours
description: ramsay sedation score at the time of pain
measure: heart rates(beat/minute)
time frame: 3 hours.
description: Intra-operative recording
measure: mean arterial pressure (mmhg)
time frame: 3 hours
description: Intra-operative recording
arm group label: Dexamethasone group
arm group type: Active Comparator
description: In this group the patients received 0.5 ml/kg of bupivacaine 0.25% + (0.1 mg/kg dexamethazone) caudally.
arm group label: Dexmedetomidine group
arm group type: Active Comparator
description: In this group the Patients received 0.5 ml/kg of bupivacaine 0.25% + dexmedetomidine(1 mu/kg) caudally.
arm group label: Combination group
arm group type: Active Comparator
description: In this group the patients received 0.5 ml/kg of bupivacaine 0.25% + dexamethasone(0.1mg/kg) and dexmedetomidine (1 mu/kg) caudally.
intervention type: Drug
intervention name: Dexamethasone
description: Dexamethasone is used peri -operatively mainly to prevent nausea and vomiting. Also epidural administration of dexamethasone prolong the postoperative analgesia and reduce analgesic needs
arm group label: Combination group
arm group label: Dexamethasone group
other name: decadron
intervention type: Drug
intervention name: Dexmedetomidine
description: Dexmedetomidine is an alpha 2 agonist which has sedative ,analgesic, opioid sparing effect and was proved to prolong the duration of postoperative analgesia when added to local anesthetics
arm group label: Combination group
arm group label: Dexmedetomidine group
other name: precedex
intervention type: Drug
intervention name: Bupivacaine
description: local anesthetic agent
arm group label: Combination group
arm group label: Dexamethasone group
arm group label: Dexmedetomidine group
other name: plain marcaine
criteria: 
gender: Male
gender based: Yes
gender description: males candidate for hypospadias surgery
minimum age: 1 Year
maximum age: 6 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Amany Hassan Saleh
investigator title: principal investigator,MD of anesthesia and intensive care unit.
mesh term: Dexamethasone
mesh term: Dexmedetomidine
mesh term: Bupivacaine
sharing ipd: No