<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/NCT04446715</url>
  </required_header>
  <id_info>
    <org_study_id>17062020</org_study_id>
    <nct_id>NCT04446715</nct_id>
  </id_info>
  <brief_title>Comparison of Meperidine and Sufentanil Added to 0.5% Hyperbaric Bupivacaine for Spinal Anesthesia in Cesarean Section</brief_title>
  <official_title>Comparison of Clinical Effects of Meperidine and Sufentanil Added to 0.5% Hyperbaric Bupivacaine for Spinal Anesthesia in Patients Undergoing Cesarean Section</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Makassed General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Makassed General Hospital</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>
      Subarachnoid block is a widely used anesthetic technique for cesarean section. To improve the&#xD;
      quality of analgesia and prolong its duration, the addition of intrathecal opioids to local&#xD;
      anesthetics has been encouraged.&#xD;
&#xD;
      In a double blind randomized controlled trial, 60 parturient women ASA 2-3 scheduled for&#xD;
      elective cesarean delivery under spinal anesthesia will be randomly divided into 2 groups:&#xD;
      Group 1 will receive sufentanil 5 μg and Group 2 will receive meperidine 12.5 mg. In every&#xD;
      group, 0.5% heavy bupivacaine 10 will be added.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A questionnaire will be used to collect data. Patients' demographic and operative&#xD;
      characteristics will be recorded. These include block level, heart rate, mean arterial&#xD;
      pressure, nausea, vomiting, shivering and use of vasopressors. Post-operative data include&#xD;
      pain, analgesic consumption, nausea and vomiting, as well as patients and surgeons&#xD;
      satisfaction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 1, 2020</start_date>
  <completion_date type="Anticipated">August 2021</completion_date>
  <primary_completion_date type="Anticipated">August 2021</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>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>First analgesic request time</measure>
    <time_frame>24 hours post operatively</time_frame>
    <description>The duration of effective analgesia is defined as the time from intrathecal injection to first patient analgesic demand</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Analgesic requirements</measure>
    <time_frame>24 hours post operatively</time_frame>
    <description>A questionnaire will be used to record the analgesics consumed by the patients</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Analgesia</condition>
  <arm_group>
    <arm_group_label>Sufentanil Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive sufentanil 5 μg in addition to 0.5% heavy bupivacaine spinal anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Meperidine Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive meperidine 12.5 mg in addition to 0.5% heavy bupivacaine spinal anesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>sufentanil</intervention_name>
    <description>Patients will receive sufentanil in spinal anesthesia</description>
    <arm_group_label>Sufentanil Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>meperidine</intervention_name>
    <description>Patients will receive meperidine in spinal anesthesia</description>
    <arm_group_label>Meperidine Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <description>Patients will receive 0.5% heavy bupivacaine in spinal anesthesia</description>
    <arm_group_label>Meperidine Group</arm_group_label>
    <arm_group_label>Sufentanil Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pregnant women with American Society of Anesthesiologist (ASA) 2-3&#xD;
&#xD;
          -  scheduled for elective cesarean section.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refuse to participate in the study,&#xD;
&#xD;
          -  requiring emergency obstetric care,&#xD;
&#xD;
          -  ASA IV or V,&#xD;
&#xD;
          -  having systemic diseases,&#xD;
&#xD;
          -  a known fetal anomaly,&#xD;
&#xD;
          -  placenta previa,&#xD;
&#xD;
          -  abruption placenta&#xD;
&#xD;
          -  with a history of hypersensitivity or allergy to any of the study drugs,&#xD;
&#xD;
          -  operation time longer than 1.5 hour,&#xD;
&#xD;
          -  blood loss more than 1500 millilitres,&#xD;
&#xD;
          -  those with any contraindication to the technique proposed,&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Saleh Kanawati, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Makassed General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Saleh Kanawati, MD</last_name>
    <phone>+9611636000</phone>
    <phone_ext>6405</phone_ext>
    <email>s.kanawati@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Makassed General Hospital</name>
      <address>
        <city>Beirut</city>
        <country>Lebanon</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Saleh Kanawati, MD</last_name>
      <phone>+9611636000</phone>
      <phone_ext>6405</phone_ext>
      <email>s.kanawati@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Lebanon</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>July 28, 2021</last_update_submitted>
  <last_update_submitted_qc>July 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Makassed General Hospital</investigator_affiliation>
    <investigator_full_name>Saleh Kanawati</investigator_full_name>
    <investigator_title>Acting chairperson</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sufentanil</mesh_term>
    <mesh_term>Meperidine</mesh_term>
    <mesh_term>Bupivacaine</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/NCT04446715
org study id: 17062020
nct id: NCT04446715
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Subarachnoid block is a widely used anesthetic technique for cesarean section. To improve the
      quality of analgesia and prolong its duration, the addition of intrathecal opioids to local
      anesthetics has been encouraged.

      In a double blind randomized controlled trial, 60 parturient women ASA 2-3 scheduled for
      elective cesarean delivery under spinal anesthesia will be randomly divided into 2 groups:
      Group 1 will receive sufentanil 5 μg and Group 2 will receive meperidine 12.5 mg. In every
      group, 0.5% heavy bupivacaine 10 will be added.
A questionnaire will be used to collect data. Patients' demographic and operative
      characteristics will be recorded. These include block level, heart rate, mean arterial
      pressure, nausea, vomiting, shivering and use of vasopressors. Post-operative data include
      pain, analgesic consumption, nausea and vomiting, as well as patients and surgeons
      satisfaction.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: First analgesic request time
time frame: 24 hours post operatively
description: The duration of effective analgesia is defined as the time from intrathecal injection to first patient analgesic demand
measure: Analgesic requirements
time frame: 24 hours post operatively
description: A questionnaire will be used to record the analgesics consumed by the patients
arm group label: Sufentanil Group
arm group type: Experimental
description: Patients will receive sufentanil 5 μg in addition to 0.5% heavy bupivacaine spinal anesthesia
arm group label: Meperidine Group
arm group type: Experimental
description: Patients will receive meperidine 12.5 mg in addition to 0.5% heavy bupivacaine spinal anesthesia
intervention type: Drug
intervention name: sufentanil
description: Patients will receive sufentanil in spinal anesthesia
arm group label: Sufentanil Group
intervention type: Drug
intervention name: meperidine
description: Patients will receive meperidine in spinal anesthesia
arm group label: Meperidine Group
intervention type: Drug
intervention name: Bupivacaine
description: Patients will receive 0.5% heavy bupivacaine in spinal anesthesia
arm group label: Meperidine Group
arm group label: Sufentanil Group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Saleh Kanawati, MD
role: Principal Investigator
affiliation: Makassed General Hospital
last name: Saleh Kanawati, MD
phone: +9611636000
phone ext: 6405
email: s.kanawati@hotmail.com
facility: 
status: Recruiting
contact: 
country: Lebanon
responsible party type: Principal Investigator
investigator affiliation: Makassed General Hospital
investigator full name: Saleh Kanawati
investigator title: Acting chairperson
mesh term: Sufentanil
mesh term: Meperidine
mesh term: Bupivacaine