<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/NCT03302208</url>
  </required_header>
  <id_info>
    <org_study_id>UTF-9</org_study_id>
    <nct_id>NCT03302208</nct_id>
  </id_info>
  <brief_title>Preoperative Oral Pregabalin Effect on Inhalational Anesthetic Requirements ln Hysterectomy Under General Anesthesia</brief_title>
  <official_title>Role of Preoperative Oral Pregabalin in Reducing Inhalational Anesthetic Requirements in Elective Abdominal Hysterectomy Under General Anesthesia: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nesrine El-Refai</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study the investigators hypothesized that preoperative pregabalin tablet (150 mg&#xD;
      orally ) may be effective in reducing intraoperative isoflurane requirements needed to&#xD;
      maintain intraoperative hemodynamics within ± 20% of baseline measurement and/or attenuates&#xD;
      hemodynamic response to endotracheal intubation in female patients ASA I or II , aged 18-60&#xD;
      years, schedule for elective abdominal hysterectomy surgery under general anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study the investigators hypothesized that preoperative pregabalin tablet (150 mg&#xD;
      orally ) would be effective in reducing intraoperative isoflurane requirement needed to&#xD;
      maintain intraoperative hemodynamics within ± 20% of baseline measurement and/or attenuates&#xD;
      hemodynamic response to endotracheal intubation in female patients ASA I or II schedule for&#xD;
      elective abdominal hysterectomy surgery under general anaesthesia.&#xD;
&#xD;
      The investigators aim to compare the efficacy of preoperative oral pregabalin versus placebo&#xD;
      in reducing intraoperative isoflurane requirements needed to maintain intraoperative&#xD;
      hemodynamic stability (Blood pressure and heart rate within ± 20% of baseline measurements)&#xD;
      in female patients ASA I/II undergoing elective abdominal hysterectomy surgery under general&#xD;
      anaesthesia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 29, 2017</start_date>
  <completion_date type="Actual">September 20, 2017</completion_date>
  <primary_completion_date type="Actual">September 1, 2017</primary_completion_date>
  <phase>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>Health Services Research</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Inhalational anaesthetic drug requirements</measure>
    <time_frame>an average of 3 hours after induction</time_frame>
    <description>Inhalational anaesthetic requirements to maintain hemodynamic stability (± 20% of the baseline) using MAQUET Flow-I anesthetic machine.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>pressor response attenuation</measure>
    <time_frame>an average of 10 minutes after induction</time_frame>
    <description>Degree of pressor response attenuation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>First time for analgesics requirement</measure>
    <time_frame>postoperative (maximum 6 hours after the end of operation)</time_frame>
    <description>First time for analgesics requirement.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Hysterectomy</condition>
  <arm_group>
    <arm_group_label>pregabalin group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pregabalin</intervention_name>
    <description>Pregabalin capsule 150 mg oral</description>
    <arm_group_label>pregabalin group</arm_group_label>
    <other_name>laryca</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female patients, aged 18-60 year scheduled for elective abdominal hysterectomy surgery&#xD;
             under general anaesthesia.&#xD;
&#xD;
          -  American Society of Anaesthesiology (ASA) physical status I or II.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  American Society of Anaesthesiology (ASA) physical status ≥ III.&#xD;
&#xD;
          -  Allergy or hypersensitivity to pregabalin.&#xD;
&#xD;
          -  Patient on calcium channel blocker or anticonvulsant.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cairo University</name>
      <address>
        <city>Cairo</city>
        <state>Zamalek</state>
        <zip>11586</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>June 29, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>January 7, 2018</last_update_submitted>
  <last_update_submitted_qc>January 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Nesrine El-Refai</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>General Anesthesia</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pregabalin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 31, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/08/NCT03302208/Prot_SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03302208
org study id: UTF-9
nct id: NCT03302208
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In this study the investigators hypothesized that preoperative pregabalin tablet (150 mg
      orally ) may be effective in reducing intraoperative isoflurane requirements needed to
      maintain intraoperative hemodynamics within ± 20% of baseline measurement and/or attenuates
      hemodynamic response to endotracheal intubation in female patients ASA I or II , aged 18-60
      years, schedule for elective abdominal hysterectomy surgery under general anesthesia.
In this study the investigators hypothesized that preoperative pregabalin tablet (150 mg
      orally ) would be effective in reducing intraoperative isoflurane requirement needed to
      maintain intraoperative hemodynamics within ± 20% of baseline measurement and/or attenuates
      hemodynamic response to endotracheal intubation in female patients ASA I or II schedule for
      elective abdominal hysterectomy surgery under general anaesthesia.

      The investigators aim to compare the efficacy of preoperative oral pregabalin versus placebo
      in reducing intraoperative isoflurane requirements needed to maintain intraoperative
      hemodynamic stability (Blood pressure and heart rate within ± 20% of baseline measurements)
      in female patients ASA I/II undergoing elective abdominal hysterectomy surgery under general
      anaesthesia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Participant, Investigator)
measure: Inhalational anaesthetic drug requirements
time frame: an average of 3 hours after induction
description: Inhalational anaesthetic requirements to maintain hemodynamic stability (± 20% of the baseline) using MAQUET Flow-I anesthetic machine.
measure: pressor response attenuation
time frame: an average of 10 minutes after induction
description: Degree of pressor response attenuation
measure: First time for analgesics requirement
time frame: postoperative (maximum 6 hours after the end of operation)
description: First time for analgesics requirement.
arm group label: pregabalin group
arm group type: Active Comparator
arm group label: placebo group
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Pregabalin
description: Pregabalin capsule 150 mg oral
arm group label: pregabalin group
other name: laryca
intervention type: Drug
intervention name: Placebo
description: Placebo
arm group label: placebo group
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Sponsor-Investigator
investigator affiliation: Cairo University
investigator full name: Nesrine El-Refai
investigator title: professor
mesh term: Pregabalin
sharing ipd: Undecided
provided document: 