<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/NCT03775655</url>
  </required_header>
  <id_info>
    <org_study_id>9076411</org_study_id>
    <nct_id>NCT03775655</nct_id>
  </id_info>
  <brief_title>Low Dose Hyperbaric Bupivacaine and Dexmedetomidine as an Adjuvant, Caesarean Section</brief_title>
  <official_title>Low Dose Hyperbaric Bupivacaine and Dexmedetomidine as an Adjuvant, Caesarean Section: Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Menoufia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Menoufia 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>
      The aim of this study is to evaluate the effectiveness of low dose scheme with&#xD;
      dexmedetomidine as an adjuvant. Taking in consideration optimum intraoperative surgical&#xD;
      conditions, best post-operative pain free experience, and more stable hemodynamic.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Actual">January 10, 2019</completion_date>
  <primary_completion_date type="Actual">January 10, 2019</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Density of motor and sensory blockade</measure>
    <time_frame>Intraoperative</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Haemodynamic stability and total doses of IV fluids and vasopressors</measure>
    <time_frame>Intraoperative</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to first postoperative rescue analgesic request</measure>
    <time_frame>24 hour</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The intraoperative patient and surgeon satisfaction (successful delivery)</measure>
    <time_frame>Intraoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The peak sensory level of block</measure>
    <time_frame>Intraoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from intrathecal injection to peak sensory block level</measure>
    <time_frame>Intraoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The time to two sensory block segment regression</measure>
    <time_frame>Intraoperative and 24 hour</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree and duration of motor block</measure>
    <time_frame>Intraoperative and 24 hour</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative analgesic supplementation during operation</measure>
    <time_frame>Intraoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain scores for 24 hours</measure>
    <time_frame>24 hour</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency and total dose of postoperative analgesics</measure>
    <time_frame>24 hour</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative and postoperative sedation scores</measure>
    <time_frame>Intraoperative and 24 hour</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of side effects: nausea, vomiting, shivering, pruritus, respiratory depression, and desaturation.</measure>
    <time_frame>Intraoperative and 24 hour</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital in stay</measure>
    <time_frame>24 hour</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to S1 level sensory regression</measure>
    <time_frame>Intraoperative and 24 hour</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Cesarean Section</condition>
  <condition>Spinal Anesthesia</condition>
  <condition>Dexmedetomidine</condition>
  <arm_group>
    <arm_group_label>LD-DEX</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will receive 7mg hyperbaric bupivacaine (about 1.4 ml of hyperbaric bupivacaine 0.5%) and 10μg dexmedetomidine (10 unit by U-100 insulin syringe using a preservative free dexmedetomidine 100μg/ml).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group will receive 12 mg hyperbaric bupivacaine (about 2.2 ml of hyperbaric bupivacaine 0.5%).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <description>10μg dexmedetomidine will be added to the injectate to be injected intrathecally</description>
    <arm_group_label>LD-DEX</arm_group_label>
    <other_name>Precedex</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Full-term pregnant women&#xD;
&#xD;
          -  Singleton gestation&#xD;
&#xD;
          -  American Society of Anaesthesiologists (ASA) physical status classes II and I&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Preterm pregnancy (&lt;37 wks. gestation)&#xD;
&#xD;
          -  Multiple gestation&#xD;
&#xD;
          -  Cardiovascular disease (e.g., preeclampsia, hypertension) and the use of&#xD;
             antihypertensive medications&#xD;
&#xD;
          -  Asthma and allergy to non-steroidal anti-inflammatory drugs&#xD;
&#xD;
          -  Conditions that prevent spinal anaesthesia&#xD;
&#xD;
          -  Failed spinal block and conversion to general anaesthesia&#xD;
&#xD;
          -  A history of established chronic pain&#xD;
&#xD;
          -  Drug addiction&#xD;
&#xD;
          -  A psychiatric disorder&#xD;
&#xD;
          -  Inability to communicate effectively&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mamdoh Lotfy, Prof. Dr.</last_name>
    <role>Study Chair</role>
    <affiliation>Faculty of Medicine - Menoufia University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Safaa M Helal, Prof. Dr.</last_name>
    <role>Study Chair</role>
    <affiliation>Faculty of Medicine - Menoufia University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Wesameldin A Soltan, Dr.</last_name>
    <role>Study Director</role>
    <affiliation>Faculty of Medicine - Menoufia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Menoufia University Hospitals</name>
      <address>
        <city>Shibīn Al Kawm</city>
        <state>Menoufia</state>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>January 13, 2019</last_update_submitted>
  <last_update_submitted_qc>January 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Menoufia University</investigator_affiliation>
    <investigator_full_name>Ahmed Ashraf Nasr</investigator_full_name>
    <investigator_title>Assisstant Lecturer Anesthesia, Intensive care and Pain management - Faculty of Medicie - Menoufia University</investigator_title>
  </responsible_party>
  <keyword>Cesarean Section</keyword>
  <keyword>Intrathecal Dexmedetomidine</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</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/NCT03775655
org study id: 9076411
nct id: NCT03775655
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate the effectiveness of low dose scheme with
      dexmedetomidine as an adjuvant. Taking in consideration optimum intraoperative surgical
      conditions, best post-operative pain free experience, and more stable hemodynamic.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Density of motor and sensory blockade
time frame: Intraoperative
measure: Haemodynamic stability and total doses of IV fluids and vasopressors
time frame: Intraoperative
measure: Time to first postoperative rescue analgesic request
time frame: 24 hour
measure: The intraoperative patient and surgeon satisfaction (successful delivery)
time frame: Intraoperative
measure: The peak sensory level of block
time frame: Intraoperative
measure: Time from intrathecal injection to peak sensory block level
time frame: Intraoperative
measure: The time to two sensory block segment regression
time frame: Intraoperative and 24 hour
measure: Degree and duration of motor block
time frame: Intraoperative and 24 hour
measure: Intraoperative analgesic supplementation during operation
time frame: Intraoperative
measure: Postoperative pain scores for 24 hours
time frame: 24 hour
measure: Frequency and total dose of postoperative analgesics
time frame: 24 hour
measure: Intraoperative and postoperative sedation scores
time frame: Intraoperative and 24 hour
measure: Incidence of side effects: nausea, vomiting, shivering, pruritus, respiratory depression, and desaturation.
time frame: Intraoperative and 24 hour
measure: Hospital in stay
time frame: 24 hour
measure: Time to S1 level sensory regression
time frame: Intraoperative and 24 hour
arm group label: LD-DEX
arm group type: Active Comparator
description: This group will receive 7mg hyperbaric bupivacaine (about 1.4 ml of hyperbaric bupivacaine 0.5%) and 10μg dexmedetomidine (10 unit by U-100 insulin syringe using a preservative free dexmedetomidine 100μg/ml).
arm group label: Control group
arm group type: No Intervention
description: This group will receive 12 mg hyperbaric bupivacaine (about 2.2 ml of hyperbaric bupivacaine 0.5%).
intervention type: Drug
intervention name: Dexmedetomidine
description: 10μg dexmedetomidine will be added to the injectate to be injected intrathecally
arm group label: LD-DEX
other name: Precedex
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mamdoh Lotfy, Prof. Dr.
role: Study Chair
affiliation: Faculty of Medicine - Menoufia University
last name: Safaa M Helal, Prof. Dr.
role: Study Chair
affiliation: Faculty of Medicine - Menoufia University
last name: Wesameldin A Soltan, Dr.
role: Study Director
affiliation: Faculty of Medicine - Menoufia University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Menoufia University
investigator full name: Ahmed Ashraf Nasr
investigator title: Assisstant Lecturer Anesthesia, Intensive care and Pain management - Faculty of Medicie - Menoufia University
mesh term: Dexmedetomidine