<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/NCT03826615</url>
  </required_header>
  <id_info>
    <org_study_id>JHSeo_gabapentin</org_study_id>
    <nct_id>NCT03826615</nct_id>
  </id_info>
  <brief_title>Gabapentin Pretreatment for Staged Bilateral Cataract Operations</brief_title>
  <official_title>The Effect of Gabapentin Pretreatment on Hyperalgesia in Elderly Patients Undergoing Staged Bilateral Cataract Operations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</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>
      To evaluate the effect of oral gabapentin premedication on hyperalgesia in elderly patients&#xD;
      undergoing staged bilateral cataract operations under monitored anesthesia care&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It has been reported that patients with bilateral cataract complained more pain and&#xD;
      discomfort during the second consecutive eye surgery compared to the first eye surgery.&#xD;
&#xD;
      Gabapentin is an anticonvulsant drug, which has been extended the use to perioperative&#xD;
      analgesia, and anxiolysis.&#xD;
&#xD;
      Therefore, the investigators conducted this randomized, controlled study to evaluate the&#xD;
      effects of gabapentin premedication on patients' subjective sensations, including&#xD;
      intraoperative anxiety, perceptions of pain, and light sensitivity, in the second cataract&#xD;
      operations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">January 3, 2020</completion_date>
  <primary_completion_date type="Actual">January 3, 2020</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>Prevention</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain perception</measure>
    <time_frame>during the operation</time_frame>
    <description>intraoperative pain perception evaluated by VAS in first and second cataract surgery</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Hyperalgesia</condition>
  <condition>Cataract Bilateral Nos</condition>
  <arm_group>
    <arm_group_label>Gabapentin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Gabapentin premedication group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No medication</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control group</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gabapentin</intervention_name>
    <description>Patients receive gabapentin 100mg orally for 3 times a day during the period of first and second cataract operations</description>
    <arm_group_label>Gabapentin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients aged over 60 years, who undergoing staged bilateral cataract operations under&#xD;
             monitored anesthesia care&#xD;
&#xD;
          -  ASA physical status of I, II, and III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  undergoing other eye operations together besides cataract operation&#xD;
&#xD;
          -  patients with creatinin clearance lower than 30ml/min&#xD;
&#xD;
          -  patients with CNS inhibitors medication&#xD;
&#xD;
          -  patients with previous gabapentin medication&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeong-Hwa Seo, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>November 9, 2020</last_update_submitted>
  <last_update_submitted_qc>November 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Jeong-Hwa Seo</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperalgesia</mesh_term>
    <mesh_term>Cataract</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gabapentin</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/NCT03826615
org study id: JHSeo_gabapentin
nct id: NCT03826615
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To evaluate the effect of oral gabapentin premedication on hyperalgesia in elderly patients
      undergoing staged bilateral cataract operations under monitored anesthesia care
It has been reported that patients with bilateral cataract complained more pain and
      discomfort during the second consecutive eye surgery compared to the first eye surgery.

      Gabapentin is an anticonvulsant drug, which has been extended the use to perioperative
      analgesia, and anxiolysis.

      Therefore, the investigators conducted this randomized, controlled study to evaluate the
      effects of gabapentin premedication on patients' subjective sensations, including
      intraoperative anxiety, perceptions of pain, and light sensitivity, in the second cataract
      operations.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
measure: Pain perception
time frame: during the operation
description: intraoperative pain perception evaluated by VAS in first and second cataract surgery
arm group label: Gabapentin
arm group type: Experimental
description: Gabapentin premedication group
arm group label: No medication
arm group type: No Intervention
description: Control group
intervention type: Drug
intervention name: Gabapentin
description: Patients receive gabapentin 100mg orally for 3 times a day during the period of first and second cataract operations
arm group label: Gabapentin
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Jeong-Hwa Seo, MD
role: Study Chair
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Jeong-Hwa Seo
investigator title: Professor
mesh term: Hyperalgesia
mesh term: Cataract
mesh term: Gabapentin