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/NCT06040060</url>
    </required_header>
    <id_info>
      <org_study_id>AN-202309.02</org_study_id>
      <nct_id>NCT06040060</nct_id>
    </id_info>
    <brief_title>Ketamine Effects as Preemptive Analgesia</brief_title>
    <official_title>Effects of Ketamine 0.5 Mg/Kgbw Administration as Preemptive Analgesia on Analgesia Duration and the Need for Fentanyl Following Hysterectomy Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universitas Padjadjaran</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Universitas Padjadjaran</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>
        The goal of this randomized controlled trial is to compare the effect of preemptive ketamine&#xD;
        administration to placebo administration in patients underwent hysterectomy surgery. The main&#xD;
        questions it aims to answer are:&#xD;
  &#xD;
          1. To determine the effect of ketamine at a dose of 0.5 mg/kgBW as preemptive analgesia on&#xD;
             the duration of analgesia after hysterectomy surgery&#xD;
  &#xD;
          2. To determine the effect of ketamine at a dose of 0.5 mg/kgBW as preemptive analgesia on&#xD;
             the need for fentanyl after hysterectomy surgery&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">December 27, 2022</start_date>
    <completion_date type="Actual">March 3, 2023</completion_date>
    <primary_completion_date type="Actual">March 3, 2023</primary_completion_date>
    <phase>Phase 2/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>Prevention</primary_purpose>
      <masking>Double (Participant, Care Provider)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Duration of postoperative analgesia</measure>
      <time_frame>24 hours post operative</time_frame>
      <description>Time interval from completion of hysterectomy until additional analgesic is needed, namely fentanyl 25 µg via PCA</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Total need for post-operative analgesic rescue</measure>
      <time_frame>24 hours post operative</time_frame>
      <description>The total amount of rescue analgetic required by research subjects, during the 24 hours after surgery, was given via PCA</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">40</enrollment>
    <condition>Pain, Postoperative</condition>
    <arm_group>
      <arm_group_label>Preemptive Ketamine</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Preemptive administration of Ketamine 0.5 mg/kgBB intravenously, given 10 minutes prior to incision</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo administration of 10 mL NaCl 0,9% intravenously, given 10 minutes prior to incision</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ketamine</intervention_name>
      <description>The intervention was prepared by the research team (anesthesia resident) in the form of ketamine which had been diluted to a dosage of 10 mg/cc, taken according to the required dose based on actual body weight then diluted with 0.9% NaCl to 10 cc. Then the two solutions were given to researchers without knowing the contents of the drugs that had been prepared by the resident who assisted in this research.</description>
      <arm_group_label>Preemptive Ketamine</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>While the 0.9% NaCl solution was used as placebo was prepared in a 10 cc syringe</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients aged 18-50 years.&#xD;
  &#xD;
            2. ASA I and II physical status (American Society of Anesthesiologists).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. The patient is not willing to be included as a research subject&#xD;
  &#xD;
            2. The patient takes anti-pain medication before surgery&#xD;
  &#xD;
            3. History of allergies to the drugs to be used&#xD;
  &#xD;
            4. History of chronic pain&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Women only</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Iwan Fuadi, MD</last_name>
      <role>Study Director</role>
      <affiliation>Faculty of Medicine Universitas Padjadjaran Bandung</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Ardi Zulfariansyah, MD</last_name>
      <role>Study Director</role>
      <affiliation>Faculty of Medicine Universitas Padjadjaran Bandung</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Universitas Padjadjaran</name>
        <address>
          <city>Bandung</city>
          <state>West Java</state>
          <zip>40161</zip>
          <country>Indonesia</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Indonesia</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 10, 2023</study_first_submitted>
    <study_first_submitted_qc>September 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 10, 2023</last_update_submitted>
    <last_update_submitted_qc>September 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Ketamine</keyword>
    <keyword>Preemptive Analgesia</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pain, Postoperative</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ketamine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06040060
  org study id: AN-202309.02
  nct id: NCT06040060
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this randomized controlled trial is to compare the effect of preemptive ketamine
        administration to placebo administration in patients underwent hysterectomy surgery. The main
        questions it aims to answer are:
  
          1. To determine the effect of ketamine at a dose of 0.5 mg/kgBW as preemptive analgesia on
             the duration of analgesia after hysterectomy surgery
  
          2. To determine the effect of ketamine at a dose of 0.5 mg/kgBW as preemptive analgesia on
             the need for fentanyl after hysterectomy surgery
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Double (Participant, Care Provider)
  measure: Duration of postoperative analgesia
  time frame: 24 hours post operative
  description: Time interval from completion of hysterectomy until additional analgesic is needed, namely fentanyl 25 µg via PCA
  measure: Total need for post-operative analgesic rescue
  time frame: 24 hours post operative
  description: The total amount of rescue analgetic required by research subjects, during the 24 hours after surgery, was given via PCA
  arm group label: Preemptive Ketamine
  arm group type: Active Comparator
  description: Preemptive administration of Ketamine 0.5 mg/kgBB intravenously, given 10 minutes prior to incision
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Placebo administration of 10 mL NaCl 0,9% intravenously, given 10 minutes prior to incision
  intervention type: Drug
  intervention name: Ketamine
  description: The intervention was prepared by the research team (anesthesia resident) in the form of ketamine which had been diluted to a dosage of 10 mg/cc, taken according to the required dose based on actual body weight then diluted with 0.9% NaCl to 10 cc. Then the two solutions were given to researchers without knowing the contents of the drugs that had been prepared by the resident who assisted in this research.
  arm group label: Preemptive Ketamine
  intervention type: Other
  intervention name: Placebo
  description: While the 0.9% NaCl solution was used as placebo was prepared in a 10 cc syringe
  arm group label: Placebo
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Women only
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: No
  last name: Iwan Fuadi, MD
  role: Study Director
  affiliation: Faculty of Medicine Universitas Padjadjaran Bandung
  last name: Ardi Zulfariansyah, MD
  role: Study Director
  affiliation: Faculty of Medicine Universitas Padjadjaran Bandung
  facility: 
  country: Indonesia
  responsible party type: Sponsor
  mesh term: Pain, Postoperative
  mesh term: Ketamine
  sharing ipd: No