<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/NCT01661803</url>
  </required_header>
  <id_info>
    <org_study_id>acpm anesthesia.dhule.</org_study_id>
    <nct_id>NCT01661803</nct_id>
  </id_info>
  <brief_title>Intrathecal Bupivacaine Versus Bupivacaine and Clonidine in Paediatrics Age Group:A Comparative Evaluation</brief_title>
  <official_title>Intrathecal Bupivacaine Versus Bupivacaine and Clonidine in Paediatrics Age Group:A Comparative Evaluation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ACPM Medical College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ACPM Medical College</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators can summarize intrathecal clonidine can potentiate bupivacaine thereby&#xD;
      bringing about better quality and longer duration of analgesia, better sedation and better&#xD;
      postoperative outcomes with minimal side effects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In our Randomized controlled, double blind study involving 30 subjects in two groups; the&#xD;
      investigators compared the safety, efficacy and quality of using intrathecal hyperbaric&#xD;
      bupivacaine 0.5% and hyperbaric bupivacaine 0.5% with clonidine 1µg/kg in paediatric patients&#xD;
      undergoing surgeries below T8 dermatome.&#xD;
&#xD;
      American Society of Anesthesiologists (ASA) Grade I patients aged between 3-10 years were&#xD;
      scheduled for the surgeries below T8 dermatome up to two hrs duration. The patients were&#xD;
      randomly allocated in - Group A-who received 0.5%of hyperbaric Bupivacaine 0.4mg/kg for 5&#xD;
      to15 kg or 0.3 mg/kg for more than 15 kg intrathecally.&#xD;
&#xD;
      Group B-who received 0.5%of hyperbaric Bupivacaine 0.4mg/kg for 5 to15 kg or 0.3 mg/kg for&#xD;
      more than 15 kg and 1µg/kg preservative free clonidine intrathecally.&#xD;
&#xD;
      The patients studied across the group did not vary much with respect to age, weight and sex&#xD;
      distribution.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2009</start_date>
  <completion_date type="Actual">January 2012</completion_date>
  <primary_completion_date type="Actual">January 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Pediatric Spinal Anesthesia</condition>
  <arm_group>
    <arm_group_label>group-A and group-B</arm_group_label>
    <description>Group-A (0.5% hyperbaric bupivacaine 0.4 mg/kg for 5-15 kg or 0.3mg/kg for &gt;15kg) and Group-B (0.5% hyperbaric bupivacaine 0.4 mg/kg for 5-15 kg or 0.3mg/kg for &gt;15 with 1 mcg/kg preservative free clonidine).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group-A and group--B</arm_group_label>
    <description>Group-A (0.5% hyperbaric bupivacaine 0.4 mg/kg for 5-15 kg or 0.3mg/kg for &gt;15kg) and Group-B (0.5% hyperbaric bupivacaine 0.4 mg/kg for 5-15 kg or 0.3mg/kg for &gt;15 with 1 mcg/kg preservative free clonidine).</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        prospective,randomized,double blind study cariied in 60 ASA grade 1 pediatric patients&#xD;
        undergoing surgeries below T8 dermatome upto two hours duration.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ASA grade-1 physical status.&#xD;
&#xD;
          2. weight 5-35kg&#xD;
&#xD;
          3. age-3 to 10 yrs&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. patients with known sensitivity to drugs to be used.&#xD;
&#xD;
          2. gross spinal deformity&#xD;
&#xD;
          3. patients in whom regional anesthesia is contraindicated.&#xD;
&#xD;
          4. patients with peripheral neuropathy.&#xD;
&#xD;
          5. patient with hemodynamic instability.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 4, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <last_update_submitted>August 9, 2012</last_update_submitted>
  <last_update_submitted_qc>August 9, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 10, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>ACPM Medical College</investigator_affiliation>
    <investigator_full_name>DR.NAGESH JAMBURE</investigator_full_name>
    <investigator_title>resident,anesthesia department,a.c.p.m.medical college,dhule,maharashtra,india</investigator_title>
  </responsible_party>
  <keyword>bupivacaine</keyword>
  <keyword>clonidine</keyword>
  <keyword>pediatric spinal</keyword>
  <keyword>efficacy</keyword>
  <keyword>duration</keyword>
  <keyword>quality</keyword>
  <keyword>side effects</keyword>
  <keyword>intrathecal bupivacaine alone</keyword>
  <keyword>bupivacaine plus clonidine</keyword>
  <!-- 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/NCT01661803
org study id: acpm anesthesia.dhule.
nct id: NCT01661803
lead sponsor: 
has dmc: Yes
The investigators can summarize intrathecal clonidine can potentiate bupivacaine thereby
      bringing about better quality and longer duration of analgesia, better sedation and better
      postoperative outcomes with minimal side effects.
In our Randomized controlled, double blind study involving 30 subjects in two groups; the
      investigators compared the safety, efficacy and quality of using intrathecal hyperbaric
      bupivacaine 0.5% and hyperbaric bupivacaine 0.5% with clonidine 1µg/kg in paediatric patients
      undergoing surgeries below T8 dermatome.

      American Society of Anesthesiologists (ASA) Grade I patients aged between 3-10 years were
      scheduled for the surgeries below T8 dermatome up to two hrs duration. The patients were
      randomly allocated in - Group A-who received 0.5%of hyperbaric Bupivacaine 0.4mg/kg for 5
      to15 kg or 0.3 mg/kg for more than 15 kg intrathecally.

      Group B-who received 0.5%of hyperbaric Bupivacaine 0.4mg/kg for 5 to15 kg or 0.3 mg/kg for
      more than 15 kg and 1µg/kg preservative free clonidine intrathecally.

      The patients studied across the group did not vary much with respect to age, weight and sex
      distribution.
observational model: Case-Control
time perspective: Prospective
arm group label: group-A and group-B
description: Group-A (0.5% hyperbaric bupivacaine 0.4 mg/kg for 5-15 kg or 0.3mg/kg for >15kg) and Group-B (0.5% hyperbaric bupivacaine 0.4 mg/kg for 5-15 kg or 0.3mg/kg for >15 with 1 mcg/kg preservative free clonidine).
arm group label: group-A and group--B
description: Group-A (0.5% hyperbaric bupivacaine 0.4 mg/kg for 5-15 kg or 0.3mg/kg for >15kg) and Group-B (0.5% hyperbaric bupivacaine 0.4 mg/kg for 5-15 kg or 0.3mg/kg for >15 with 1 mcg/kg preservative free clonidine).
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 3 Years
maximum age: 10 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: ACPM Medical College
investigator full name: DR.NAGESH JAMBURE
investigator title: resident,anesthesia department,a.c.p.m.medical college,dhule,maharashtra,india