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/NCT06031883</url>
    </required_header>
    <id_info>
      <org_study_id>685-2023</org_study_id>
      <nct_id>NCT06031883</nct_id>
    </id_info>
    <brief_title>Efficacy of Adding Low Dose Ketamine or Fentanyl to Propofol-dexmedetomidine as Total Intravenous Anesthesia</brief_title>
    <acronym>TIVA</acronym>
    <official_title>Efficacy of Adding Low Dose Ketamine or Fentanyl to Propofol-dexmedetomidine as Total Intravenous Anesthesia for Patients Undergoing Craniotomy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Minia University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Minia University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Efficacy of adding low dose ketamine or fentanyl to propofol-dexmedetomidine as total&#xD;
        intravenous anesthesia for patients undergoing craniotomy in supra tentorial brain tumor&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Efficacy of adding low dose ketamine or fentanyl to propofol-dexmedetomidine as total&#xD;
        intravenous anesthesia for patients undergoing craniotomy in supra tentorial brain tumor&#xD;
        surgery on brain relaxation score, hemodynamics, surgeon satisfaction score , total&#xD;
        requirement of intra operative propofol and post operative analgesia&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 1, 2023</start_date>
    <completion_date type="Anticipated">April 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 1, 2024</primary_completion_date>
    <phase>Phase 1/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>Other</primary_purpose>
      <masking>Single (Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Evaluation of brain relaxation score</measure>
      <time_frame>2 hours</time_frame>
      <description>1:perfectly relaxed , 2:satisfactory relaxed , 3:firm brain and 4:bulging brain</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Randomised Triple Blinded Study</condition>
    <arm_group>
      <arm_group_label>1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Ketamine group recieve induction and maintenance doses of ketamine by target controlled infusion</description>
    </arm_group>
    <arm_group>
      <arm_group_label>2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Fentanyl group recieve induction and maintenance doses of fentanyl by target controlled infusion</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ketamine</intervention_name>
      <description>Total intravenous anesthesia in craniotomy</description>
      <arm_group_label>1</arm_group_label>
      <arm_group_label>2</arm_group_label>
      <other_name>Fentanyl</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          - Patients aged 18-70 years old ASA I - III with GCS 14-15 and BMI&lt;35 scheduled for&#xD;
          elective craniotomy for resection of supratentorial masses&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients will be excluded if they will refuse to give a written consent. Also patients&#xD;
               with GCS &lt; 14 or having endocrine or blood diseases or sever cardiac disease or sever&#xD;
               liver disease or renal failure and patients with uncontrolled hypertension or&#xD;
               uncontrolled diabetes mellitus and patients have allergy to any of the study drugs.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Eron Ashraf Faried</last_name>
      <phone>01066197115</phone>
      <email>roneashraf20@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Amr Nady Abdlrazek</last_name>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Eron</name>
        <address>
          <city>Minya</city>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Eron Ashraf Faried</last_name>
        <phone>01066197115</phone>
        <email>roneashraf20@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 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>Minia University</investigator_affiliation>
      <investigator_full_name>Eron Ashraf Faried</investigator_full_name>
      <investigator_title>Eron Ashraf Faried</investigator_title>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fentanyl</mesh_term>
      <mesh_term>Ketamine</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/NCT06031883
  org study id: 685-2023
  nct id: NCT06031883
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  Efficacy of adding low dose ketamine or fentanyl to propofol-dexmedetomidine as total
        intravenous anesthesia for patients undergoing craniotomy in supra tentorial brain tumor
  Efficacy of adding low dose ketamine or fentanyl to propofol-dexmedetomidine as total
        intravenous anesthesia for patients undergoing craniotomy in supra tentorial brain tumor
        surgery on brain relaxation score, hemodynamics, surgeon satisfaction score , total
        requirement of intra operative propofol and post operative analgesia
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Single (Investigator)
  measure: Evaluation of brain relaxation score
  time frame: 2 hours
  description: 1:perfectly relaxed , 2:satisfactory relaxed , 3:firm brain and 4:bulging brain
  arm group label: 1
  arm group type: Experimental
  description: Ketamine group recieve induction and maintenance doses of ketamine by target controlled infusion
  arm group label: 2
  arm group type: Experimental
  description: Fentanyl group recieve induction and maintenance doses of fentanyl by target controlled infusion
  intervention type: Drug
  intervention name: Ketamine
  description: Total intravenous anesthesia in craniotomy
  arm group label: 1
  arm group label: 2
  other name: Fentanyl
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Eron Ashraf Faried
  phone: 01066197115
  email: roneashraf20@gmail.com
  last name: Amr Nady Abdlrazek
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Minia University
  investigator full name: Eron Ashraf Faried
  investigator title: Eron Ashraf Faried
  mesh term: Fentanyl
  mesh term: Ketamine