xml: <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/NCT06031090</url>
    </required_header>
    <id_info>
      <org_study_id>zu-IRB#10415/26-2-2023</org_study_id>
      <nct_id>NCT06031090</nct_id>
    </id_info>
    <brief_title>Clonidine Versus Granisetron for Shivering Prevension</brief_title>
    <official_title>Intravenous Clonidine Versus Granisetron for Prevention of Post Spinal Anesthesia Shivering in Cesarean Section</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zagazig University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Zagazig 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>
        Prevention of post spinal anesthesia shivering during cesarean section with its associated&#xD;
        discomfort, distress, aggravation of pain, increased metabolic demands, and increased oxygen&#xD;
        consumption&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Shivering is one of the most important periperative complications seen in clinical practice.&#xD;
        Several mechanisms have been postulated for its pathogenesis. Anesthetic-induced inhibition&#xD;
        of thermoregulation resulting in hypothermia is an important cause of post anesthesia&#xD;
        shivering, uncontrolled spinal reflexes, and cutaneous vasodilation are the other suggested&#xD;
        mechanisms involved in the pathogenesis of shivering. Opioid receptors, α2 receptors, and&#xD;
        serotonergic receptors also are involved of shivering.&#xD;
  &#xD;
        Various drugs were studied for their potential role in prevention of peri-operative shivering&#xD;
        such as tramadol, dexmedetomidine, ondansetron, ketamine, and pethidine.&#xD;
  &#xD;
        We decided to perform a well-designed study to compare clonidine and granisetron which has&#xD;
        been recently introduced as drugs for prevention and control of shivering after spinal&#xD;
        anesthesia.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 5, 2023</start_date>
    <completion_date type="Anticipated">October 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 5, 2023</primary_completion_date>
    <phase>Phase 2</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>Prevention</primary_purpose>
      <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
      <masking_description>triple blinded</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of Shivering</measure>
      <time_frame>Procedure (through out the period of spinal anesthesia)</time_frame>
      <description>• Shivering will be graded according to Tsai and Chu scale (10): 0 = no shivering, 1 = piloerection or peripheral vasoconstriction but no visible shivering, 2 = muscular activity in only one muscle group, 3 = muscular activity in more than one muscle group but not generalized shivering, 4 =shivering involving the whole body</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>core body temperature</measure>
      <time_frame>Procedure (preoperative as base and through out the period of spinal anesthesia)</time_frame>
      <description>Core body temperature was detected by measuring tympanic membrane temperature using digital infrared ear thermometer (thermoscan KFT-10; Grnzia, genova, Italy).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maternal Heart rate</measure>
      <time_frame>Procedure (preoperative as base and through out the period of spinal anesthesia)</time_frame>
      <description>beats/minute</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>baby APGAR score</measure>
      <time_frame>1 minutes and 5 minutes post natal</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>maternal blood presure</measure>
      <time_frame>Procedure (preoperative as base and through out the period of spinal anesthesia)</time_frame>
      <description>mmhg</description>
    </secondary_outcome>
    <other_outcome>
      <measure>maternal oxygen saturation</measure>
      <time_frame>Procedure (preoperative as base and through out the period of spinal anesthesia)</time_frame>
    </other_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">186</enrollment>
    <condition>Post Spinal Anesthesia Shivering</condition>
    <arm_group>
      <arm_group_label>Group Cl (clonidine group)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>will be given intravenous Clonidine 0.5 µg/kg diluted in 10ml normal saline 20 minutes before spinal anesthesia</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group G (granisetron group)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>will be given intravenous 1mg of granisetron 20 minutes before spinal anesthesia.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group C (control group)</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>will be given intravenous10ml normal saline 20 minutes before spinal anesthesia</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Clonidine Injection</intervention_name>
      <description>intravenous Clonidine 0.5 µg/kg diluted in 10ml normal saline 20 minutes before spinal anesthesia</description>
      <arm_group_label>Group Cl (clonidine group)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Granisetron Injection</intervention_name>
      <description>intravenous 1mg of granisetron diluted in 10ml normal saline 20 minutes before spinal anesthesia.</description>
      <arm_group_label>Group G (granisetron group)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Normal Saline 10 mL Injection</intervention_name>
      <description>intravenous 10 ml normal saline 20 minutes before spinal anesthesia</description>
      <arm_group_label>Group C (control group)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria: Patient acceptance.,Aged between 21-40 years old, BMI: 18- 30 kg/m2,&#xD;
          ASA: I and II., Scheduled for elective cesarean section under spinal anesthesia.&#xD;
  &#xD;
          -&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          History of hypersensitivity to drugs used in this study,Patients with history of chronic&#xD;
          pain and taking analgesics, Patients with sepsis and Significant cardiac, liver or renal&#xD;
          diseases, Uncooperative patients or with psychiatric disorders that prevent surgery under&#xD;
          spinal anesthesia, Atrio-ventricular block in any degree, cardiac arrhythmias, valvular&#xD;
          heart disease, kidney or liver diseases, neuromuscular disorders and diabetes mellitus&#xD;
  &#xD;
          -&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>parturients undergoing cesarean section</gender_description>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Heba M Fathi, M.D</last_name>
      <phone>00201000143938</phone>
      <email>heba_elgendi@yahoo.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Heba M Fathi</name>
        <address>
          <city>Zagazig</city>
          <zip>44519</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Heba M Fathi, M.D</last_name>
        <phone>002-01000143938</phone>
        <email>heba_elgendi@yahoo.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 27, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Zagazig University</investigator_affiliation>
      <investigator_full_name>Heba M Fathi</investigator_full_name>
      <investigator_title>Ass. Professor</investigator_title>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Clonidine</mesh_term>
      <mesh_term>Granisetron</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06031090
  org study id: zu-IRB#10415/26-2-2023
  nct id: NCT06031090
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Prevention of post spinal anesthesia shivering during cesarean section with its associated
        discomfort, distress, aggravation of pain, increased metabolic demands, and increased oxygen
        consumption
  Shivering is one of the most important periperative complications seen in clinical practice.
        Several mechanisms have been postulated for its pathogenesis. Anesthetic-induced inhibition
        of thermoregulation resulting in hypothermia is an important cause of post anesthesia
        shivering, uncontrolled spinal reflexes, and cutaneous vasodilation are the other suggested
        mechanisms involved in the pathogenesis of shivering. Opioid receptors, α2 receptors, and
        serotonergic receptors also are involved of shivering.
  
        Various drugs were studied for their potential role in prevention of peri-operative shivering
        such as tramadol, dexmedetomidine, ondansetron, ketamine, and pethidine.
  
        We decided to perform a well-designed study to compare clonidine and granisetron which has
        been recently introduced as drugs for prevention and control of shivering after spinal
        anesthesia.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Triple (Participant, Care Provider, Outcomes Assessor)
  masking description: triple blinded
  measure: Incidence of Shivering
  time frame: Procedure (through out the period of spinal anesthesia)
  description: • Shivering will be graded according to Tsai and Chu scale (10): 0 = no shivering, 1 = piloerection or peripheral vasoconstriction but no visible shivering, 2 = muscular activity in only one muscle group, 3 = muscular activity in more than one muscle group but not generalized shivering, 4 =shivering involving the whole body
  measure: core body temperature
  time frame: Procedure (preoperative as base and through out the period of spinal anesthesia)
  description: Core body temperature was detected by measuring tympanic membrane temperature using digital infrared ear thermometer (thermoscan KFT-10; Grnzia, genova, Italy).
  measure: Maternal Heart rate
  time frame: Procedure (preoperative as base and through out the period of spinal anesthesia)
  description: beats/minute
  measure: baby APGAR score
  time frame: 1 minutes and 5 minutes post natal
  measure: maternal blood presure
  time frame: Procedure (preoperative as base and through out the period of spinal anesthesia)
  description: mmhg
  measure: maternal oxygen saturation
  time frame: Procedure (preoperative as base and through out the period of spinal anesthesia)
  arm group label: Group Cl (clonidine group)
  arm group type: Active Comparator
  description: will be given intravenous Clonidine 0.5 µg/kg diluted in 10ml normal saline 20 minutes before spinal anesthesia
  arm group label: Group G (granisetron group)
  arm group type: Active Comparator
  description: will be given intravenous 1mg of granisetron 20 minutes before spinal anesthesia.
  arm group label: Group C (control group)
  arm group type: Placebo Comparator
  description: will be given intravenous10ml normal saline 20 minutes before spinal anesthesia
  intervention type: Drug
  intervention name: Clonidine Injection
  description: intravenous Clonidine 0.5 µg/kg diluted in 10ml normal saline 20 minutes before spinal anesthesia
  arm group label: Group Cl (clonidine group)
  intervention type: Drug
  intervention name: Granisetron Injection
  description: intravenous 1mg of granisetron diluted in 10ml normal saline 20 minutes before spinal anesthesia.
  arm group label: Group G (granisetron group)
  intervention type: Drug
  intervention name: Normal Saline 10 mL Injection
  description: intravenous 10 ml normal saline 20 minutes before spinal anesthesia
  arm group label: Group C (control group)
  criteria: 
  gender: Female
  gender based: Yes
  gender description: parturients undergoing cesarean section
  minimum age: 21 Years
  maximum age: 40 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Heba M Fathi, M.D
  phone: 00201000143938
  email: heba_elgendi@yahoo.com
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Zagazig University
  investigator full name: Heba M Fathi
  investigator title: Ass. Professor
  mesh term: Clonidine
  mesh term: Granisetron