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/NCT05969119</url>
    </required_header>
    <id_info>
      <org_study_id>SUEZ Med-IRB 1/2023</org_study_id>
      <nct_id>NCT05969119</nct_id>
    </id_info>
    <brief_title>Addition of Pyridostigmine to Conventional Management of Postdural Puncture Headache</brief_title>
    <official_title>Addition of Pyridostigmine to Conventional Management of Postdural Puncture Headache</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ain Shams University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ain Shams University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Postdural puncture headache (PDPH) is a major complication of neuraxial anesthesia that can&#xD;
        occur following spinal anesthesia and with inadvertent Dural puncture during epidural&#xD;
        anesthesia. The presence of Pyridostigmine in CSF would be expected to increase the level of&#xD;
        acetylcholine in CSF and subsequently in the brain through inhibition of cholinesterase. The&#xD;
        increased level of acetylcholine would produce cerebral vasoconstriction.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">July 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
    <phase>Phase 4</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.</measure>
      <time_frame>15 minutes after sitting upright</time_frame>
      <description>Participants will be asked to report the severity of their headache after sitting upright for 15 minutes, using a 10-cm VAS( Visual analogue scale) where 10 refers to the worst pain at 0 hours.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.</measure>
      <time_frame>6 hours</time_frame>
      <description>Participants will be asked to report the severity of their headache after sitting upright for 15 minutes, using a 10-cm VAS( Visual analogue scale) after 6 hours.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.</measure>
      <time_frame>12 hours</time_frame>
      <description>Participants will be asked to report the severity of their headache after sitting upright for 15 minutes, using a 10-cm VAS( Visual analogue scale) after 12 hours.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.</measure>
      <time_frame>24 hours</time_frame>
      <description>Participants will be asked to report the severity of their headache after sitting upright for 15 minutes, using a 10-cm VAS( Visual analogue scale) after 24 hours.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.</measure>
      <time_frame>36 hours</time_frame>
      <description>Participants will be asked to report the severity of their headache after sitting upright for 15 minutes, using a 10-cm VAS( Visual analogue scale) after 36 hours.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.</measure>
      <time_frame>48 hours</time_frame>
      <description>Participants will be asked to report the severity of their headache after sitting upright for 15 minutes, using a 10-cm VAS( Visual analogue scale) after 48 hours.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.</measure>
      <time_frame>72 hours</time_frame>
      <description>Participants will be asked to report the severity of their headache after sitting upright for 15 minutes, using a 10-cm VAS( Visual analogue scale) after 72hours.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The need for an Epidural blood patch in the Pyridostigmine and control groups.</measure>
      <time_frame>72 hours</time_frame>
      <description>An EBP will be performed during the study if the VAS(Visual analogue scale) will be ≥5 after 72 hours from intervention start following parturient approval and consent, or if requested by the parturient at any time during the study.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Appearance of neck stiffness in the Pyridostigmine and control groups.</measure>
      <time_frame>Before giving the Pyridostigmine or the Placebo</time_frame>
      <description>Appearance of neck stiffness in the Pyridostigmine and control groups and will be recorded after asking the patients by yes or no.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Appearance of neck stiffness in the Pyridostigmine and control groups.</measure>
      <time_frame>6 hours after the intervention</time_frame>
      <description>Appearance of neck stiffness in the Pyridostigmine and control groups and will be recorded after asking the patients by yes or no.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Appearance of neck stiffness in the Pyridostigmine and control groups.</measure>
      <time_frame>12 hours after the intervention</time_frame>
      <description>Appearance of neck stiffness in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Appearance of neck stiffness in the Pyridostigmine and control groups.</measure>
      <time_frame>24 hours after the intervention</time_frame>
      <description>Appearance of neck stiffness in the Pyridostigmine and control groups and will be recorded after asking the patients by yes or no.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Appearance of neck stiffness in the Pyridostigmine and control groups.</measure>
      <time_frame>36 hours after the intervention</time_frame>
      <description>Appearance of neck stiffness in the Pyridostigmine and control groups and will be recorded after asking the patients by yes or no.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Appearance of neck stiffness in the Pyridostigmine and control groups.</measure>
      <time_frame>48 hours after the intervention</time_frame>
      <description>Appearance of neck stiffness in the Pyridostigmine and control groups and will be recorded after asking the patients by yes or no.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Appearance of neck stiffness in the Pyridostigmine and control groups.</measure>
      <time_frame>72 hours after the intervention</time_frame>
      <description>Appearance of neck stiffness in the Pyridostigmine and control groups and will be recorded after asking the patients by yes or no.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Appearance of Nausea and vomiting in the Pyridostigmine and control groups.</measure>
      <time_frame>Before giving the Pyridostigmine or the Placebo</time_frame>
      <description>Appearance of Nausea and vomiting in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Appearance of Nausea and vomiting in the Pyridostigmine and control groups.</measure>
      <time_frame>6 hours after the intervention</time_frame>
      <description>Appearance of Nausea and vomiting in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Appearance of Nausea and vomiting in the Pyridostigmine and control groups.</measure>
      <time_frame>12 hours after the intervention</time_frame>
      <description>Appearance of Nausea and vomiting in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Appearance of Nausea and vomiting in the Pyridostigmine and control groups.</measure>
      <time_frame>24 hours after the intervention</time_frame>
      <description>Appearance of Nausea and vomiting in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Appearance of Nausea and vomiting in the Pyridostigmine and control groups.</measure>
      <time_frame>36 hours after the intervention</time_frame>
      <description>Appearance of Nausea and vomiting in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Appearance of Nausea and vomiting in the Pyridostigmine and control groups.</measure>
      <time_frame>48 hours after the intervention</time_frame>
      <description>Appearance of Nausea and vomiting in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Appearance of Nausea and vomiting in the Pyridostigmine and control groups.</measure>
      <time_frame>72 hours after the intervention</time_frame>
      <description>Appearance of Nausea and vomiting in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Postdural Puncture Headache</condition>
    <arm_group>
      <arm_group_label>Pyridostigmine</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Parturients with postoperative PDPH and a VAS score of ≥5 will receive either 60 mg oral Pyridostigmine every 6 hours.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Parturients with postoperative PDPH and a VAS score of ≥5 will receive placebo tablets similar in shape to pyridostigmine tablets every 6 hours.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Pyridostigmine</intervention_name>
      <description>Parturients with postoperative Postdural puncture headache and a Visual analogue scale (VAS score) of ≥5 will receive either 60 mg oral Pyridostigmine every 6 hours or Placebo tablets similar in shape to pyridostigmine tablets every 6 hours.</description>
      <arm_group_label>Pyridostigmine</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Parturients with postoperative Postdural puncture headache and a Visual analogue scale (VAS score) of ≥5 will receive Placebo tablets similar in shape to pyridostigmine tablets every 6 hours.</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients American Society of anesthesiologists' physical status (ASA) II because of&#xD;
               pregnancy.&#xD;
  &#xD;
            -  Patients diagnosed with Postdural puncture headache following intrathecal spinal&#xD;
               anesthesia for elective caesarean delivery.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients with PDPH and a visual analog scale (VAS) score &lt;5.&#xD;
  &#xD;
            2. Patients with history of chronic headache, cluster headache, migraine, convulsions.&#xD;
  &#xD;
            3. Patients with history of cerebrovascular accident, previous neurological diseases.&#xD;
  &#xD;
            4. Patients with preeclampsia, eclampsia, coagulopathy.&#xD;
  &#xD;
            5. Patients with severe bleeding (&gt;20% of blood volume).&#xD;
  &#xD;
            6. Patients undergoing treatment with vasopressors.&#xD;
  &#xD;
            7. Patients with bronchial asthma.&#xD;
  &#xD;
            8. Patients with arrhythmia, and any type of heart block.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Riham Fa Galal, Lecturer</last_name>
      <phone>+201022739211</phone>
      <email>rihamfathygalal@gmail.com</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 29, 2023</last_update_submitted>
    <last_update_submitted_qc>July 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ain Shams University</investigator_affiliation>
      <investigator_full_name>riham fathy galal</investigator_full_name>
      <investigator_title>Lecturer of Anesthesia intensive care and pain management</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Post-Dural Puncture Headache</mesh_term>
      <mesh_term>Headache</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pyridostigmine Bromide</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>1 year after study publication.</ipd_time_frame>
      <ipd_access_criteria>available to all</ipd_access_criteria>
    </patient_data>
    <!-- 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/NCT05969119
  org study id: SUEZ Med-IRB 1/2023
  nct id: NCT05969119
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Postdural puncture headache (PDPH) is a major complication of neuraxial anesthesia that can
        occur following spinal anesthesia and with inadvertent Dural puncture during epidural
        anesthesia. The presence of Pyridostigmine in CSF would be expected to increase the level of
        acetylcholine in CSF and subsequently in the brain through inhibition of cholinesterase. The
        increased level of acetylcholine would produce cerebral vasoconstriction.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.
  time frame: 15 minutes after sitting upright
  description: Participants will be asked to report the severity of their headache after sitting upright for 15 minutes, using a 10-cm VAS( Visual analogue scale) where 10 refers to the worst pain at 0 hours.
  measure: The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.
  time frame: 6 hours
  description: Participants will be asked to report the severity of their headache after sitting upright for 15 minutes, using a 10-cm VAS( Visual analogue scale) after 6 hours.
  measure: The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.
  time frame: 12 hours
  description: Participants will be asked to report the severity of their headache after sitting upright for 15 minutes, using a 10-cm VAS( Visual analogue scale) after 12 hours.
  measure: The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.
  time frame: 24 hours
  description: Participants will be asked to report the severity of their headache after sitting upright for 15 minutes, using a 10-cm VAS( Visual analogue scale) after 24 hours.
  measure: The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.
  time frame: 36 hours
  description: Participants will be asked to report the severity of their headache after sitting upright for 15 minutes, using a 10-cm VAS( Visual analogue scale) after 36 hours.
  measure: The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.
  time frame: 48 hours
  description: Participants will be asked to report the severity of their headache after sitting upright for 15 minutes, using a 10-cm VAS( Visual analogue scale) after 48 hours.
  measure: The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.
  time frame: 72 hours
  description: Participants will be asked to report the severity of their headache after sitting upright for 15 minutes, using a 10-cm VAS( Visual analogue scale) after 72hours.
  measure: The need for an Epidural blood patch in the Pyridostigmine and control groups.
  time frame: 72 hours
  description: An EBP will be performed during the study if the VAS(Visual analogue scale) will be ≥5 after 72 hours from intervention start following parturient approval and consent, or if requested by the parturient at any time during the study.
  measure: Appearance of neck stiffness in the Pyridostigmine and control groups.
  time frame: Before giving the Pyridostigmine or the Placebo
  description: Appearance of neck stiffness in the Pyridostigmine and control groups and will be recorded after asking the patients by yes or no.
  measure: Appearance of neck stiffness in the Pyridostigmine and control groups.
  time frame: 6 hours after the intervention
  description: Appearance of neck stiffness in the Pyridostigmine and control groups and will be recorded after asking the patients by yes or no.
  measure: Appearance of neck stiffness in the Pyridostigmine and control groups.
  time frame: 12 hours after the intervention
  description: Appearance of neck stiffness in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.
  measure: Appearance of neck stiffness in the Pyridostigmine and control groups.
  time frame: 24 hours after the intervention
  description: Appearance of neck stiffness in the Pyridostigmine and control groups and will be recorded after asking the patients by yes or no.
  measure: Appearance of neck stiffness in the Pyridostigmine and control groups.
  time frame: 36 hours after the intervention
  description: Appearance of neck stiffness in the Pyridostigmine and control groups and will be recorded after asking the patients by yes or no.
  measure: Appearance of neck stiffness in the Pyridostigmine and control groups.
  time frame: 48 hours after the intervention
  description: Appearance of neck stiffness in the Pyridostigmine and control groups and will be recorded after asking the patients by yes or no.
  measure: Appearance of neck stiffness in the Pyridostigmine and control groups.
  time frame: 72 hours after the intervention
  description: Appearance of neck stiffness in the Pyridostigmine and control groups and will be recorded after asking the patients by yes or no.
  measure: Appearance of Nausea and vomiting in the Pyridostigmine and control groups.
  time frame: Before giving the Pyridostigmine or the Placebo
  description: Appearance of Nausea and vomiting in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.
  measure: Appearance of Nausea and vomiting in the Pyridostigmine and control groups.
  time frame: 6 hours after the intervention
  description: Appearance of Nausea and vomiting in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.
  measure: Appearance of Nausea and vomiting in the Pyridostigmine and control groups.
  time frame: 12 hours after the intervention
  description: Appearance of Nausea and vomiting in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.
  measure: Appearance of Nausea and vomiting in the Pyridostigmine and control groups.
  time frame: 24 hours after the intervention
  description: Appearance of Nausea and vomiting in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.
  measure: Appearance of Nausea and vomiting in the Pyridostigmine and control groups.
  time frame: 36 hours after the intervention
  description: Appearance of Nausea and vomiting in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.
  measure: Appearance of Nausea and vomiting in the Pyridostigmine and control groups.
  time frame: 48 hours after the intervention
  description: Appearance of Nausea and vomiting in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.
  measure: Appearance of Nausea and vomiting in the Pyridostigmine and control groups.
  time frame: 72 hours after the intervention
  description: Appearance of Nausea and vomiting in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.
  arm group label: Pyridostigmine
  arm group type: Experimental
  description: Parturients with postoperative PDPH and a VAS score of ≥5 will receive either 60 mg oral Pyridostigmine every 6 hours.
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Parturients with postoperative PDPH and a VAS score of ≥5 will receive placebo tablets similar in shape to pyridostigmine tablets every 6 hours.
  intervention type: Drug
  intervention name: Pyridostigmine
  description: Parturients with postoperative Postdural puncture headache and a Visual analogue scale (VAS score) of ≥5 will receive either 60 mg oral Pyridostigmine every 6 hours or Placebo tablets similar in shape to pyridostigmine tablets every 6 hours.
  arm group label: Pyridostigmine
  intervention type: Drug
  intervention name: Placebo
  description: Parturients with postoperative Postdural puncture headache and a Visual analogue scale (VAS score) of ≥5 will receive Placebo tablets similar in shape to pyridostigmine tablets every 6 hours.
  arm group label: Placebo
  criteria: 
  gender: All
  gender based: Yes
  minimum age: 20 Years
  maximum age: 40 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Riham Fa Galal, Lecturer
  phone: +201022739211
  email: rihamfathygalal@gmail.com
  responsible party type: Principal Investigator
  investigator affiliation: Ain Shams University
  investigator full name: riham fathy galal
  investigator title: Lecturer of Anesthesia intensive care and pain management
  mesh term: Post-Dural Puncture Headache
  mesh term: Headache
  mesh term: Pyridostigmine Bromide
  sharing ipd: Yes
  ipd info type: Study Protocol
  ipd time frame: 1 year after study publication.
  ipd access criteria: available to all