<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/NCT03806374</url>
  </required_header>
  <id_info>
    <org_study_id>ASUH9418</org_study_id>
    <nct_id>NCT03806374</nct_id>
  </id_info>
  <brief_title>Is it Possible to Replace Fentanyl in Anesthesia for Minor Procedures?</brief_title>
  <official_title>Is it Possible to Replace Fentanyl by Non Narcotic Medication for Induction and Maintenance of Anesthesia in Minor Procedures?</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>
    <has_dmc>No</has_dmc>
    <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>
      To compare between fentanyl group and ketamine lidocaine group for induction of anesthesia as&#xD;
      regards hemodynamics and smooth intubation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Two groups each with 60 patients Group I anesthesia initiated by propofol, fentanyl and&#xD;
      cisatracurium. Group II anesthesia initiated by ketamine, lidocaine, propofol and&#xD;
      cisatracurium.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2, 2018</start_date>
  <completion_date type="Actual">December 10, 2018</completion_date>
  <primary_completion_date type="Actual">December 1, 2018</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 (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intubation with less hemodynamic changes</measure>
    <time_frame>15 minutes after induction of anesthesia.</time_frame>
    <description>changes in blood pressure with intubation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Smooth Maintenance of anesthesia</measure>
    <time_frame>anesthesia time</time_frame>
    <description>changes in blood pressure during anesthesia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>less postoperative pain killers</measure>
    <time_frame>24 hours postoperative</time_frame>
    <description>amount of pain killers used and timing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intubation with less hemodynamic changes</measure>
    <time_frame>Anesthesia time</time_frame>
    <description>changes in pulse rate during anesthesia</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>Fentanyl</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Administered propofol and fentanyl for induction.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ketamine and lidocaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Administered propofol, ketamine and lidocaine for induction.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketamine</intervention_name>
    <description>ketamine</description>
    <arm_group_label>Ketamine and lidocaine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol</intervention_name>
    <description>propofol</description>
    <arm_group_label>Fentanyl</arm_group_label>
    <arm_group_label>Ketamine and lidocaine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fentanyl</intervention_name>
    <description>fentanyl</description>
    <arm_group_label>Fentanyl</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisatracurium</intervention_name>
    <description>cisatracurium</description>
    <arm_group_label>Fentanyl</arm_group_label>
    <arm_group_label>Ketamine and lidocaine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine</intervention_name>
    <description>lidocaine</description>
    <arm_group_label>Ketamine and lidocaine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I and II between&#xD;
&#xD;
          -  Age between 18-55 years&#xD;
&#xD;
          -  Undergoing minor surgical procedure less than an hour.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with hypertension&#xD;
&#xD;
          -  Patients with Ischemic heart diseases&#xD;
&#xD;
          -  Patients with chronic renal or liver diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ain Shams University hospitals</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>January 15, 2019</last_update_submitted>
  <last_update_submitted_qc>January 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Ayman Anis Metry</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <keyword>fentanyl</keyword>
  <keyword>lidocaine</keyword>
  <keyword>ketamine</keyword>
  <keyword>induction of anesthesia</keyword>
  <keyword>intubation</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Fentanyl</mesh_term>
    <mesh_term>Ketamine</mesh_term>
    <mesh_term>Propofol</mesh_term>
    <mesh_term>Cisatracurium</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03806374
org study id: ASUH9418
nct id: NCT03806374
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
To compare between fentanyl group and ketamine lidocaine group for induction of anesthesia as
      regards hemodynamics and smooth intubation.
Two groups each with 60 patients Group I anesthesia initiated by propofol, fentanyl and
      cisatracurium. Group II anesthesia initiated by ketamine, lidocaine, propofol and
      cisatracurium.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Care Provider)
measure: Intubation with less hemodynamic changes
time frame: 15 minutes after induction of anesthesia.
description: changes in blood pressure with intubation
measure: Smooth Maintenance of anesthesia
time frame: anesthesia time
description: changes in blood pressure during anesthesia
measure: less postoperative pain killers
time frame: 24 hours postoperative
description: amount of pain killers used and timing
measure: Intubation with less hemodynamic changes
time frame: Anesthesia time
description: changes in pulse rate during anesthesia
arm group label: Fentanyl
arm group type: Active Comparator
description: Administered propofol and fentanyl for induction.
arm group label: Ketamine and lidocaine
arm group type: Active Comparator
description: Administered propofol, ketamine and lidocaine for induction.
intervention type: Drug
intervention name: Ketamine
description: ketamine
arm group label: Ketamine and lidocaine
intervention type: Drug
intervention name: Propofol
description: propofol
arm group label: Fentanyl
arm group label: Ketamine and lidocaine
intervention type: Drug
intervention name: Fentanyl
description: fentanyl
arm group label: Fentanyl
intervention type: Drug
intervention name: Cisatracurium
description: cisatracurium
arm group label: Fentanyl
arm group label: Ketamine and lidocaine
intervention type: Drug
intervention name: Lidocaine
description: lidocaine
arm group label: Ketamine and lidocaine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Ayman Anis Metry
investigator title: Assistant professor
mesh term: Lidocaine
mesh term: Fentanyl
mesh term: Ketamine
mesh term: Propofol
mesh term: Cisatracurium
sharing ipd: No