<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/NCT03235609</url>
  </required_header>
  <id_info>
    <org_study_id>17100212</org_study_id>
    <nct_id>NCT03235609</nct_id>
  </id_info>
  <brief_title>Sedation During Pediatric Diagnostic Gastrointestinal Endoscopy Gastrointestinal Endoscopy</brief_title>
  <official_title>Propofol-Ketamine vs. Propofol-Fentanyl for Sedation During Pediatric Diagnostic Gastrointestinal Endoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      comparison between propofol-fentanyl and propofol-ketamine for sedation in pediatric&#xD;
      diagnostic gastrointestinal endoscopy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is a prospective double blinded controlled study that will be carried out on 60 pediatric&#xD;
      patients undergoing GIT endoscopy; they will be divided into two groups of 30 patients each:-&#xD;
      Group I (PF): will receive 0.5 µg/ kg fentanyl + 2 mg/ kg propofol IV. Group II (KF): will&#xD;
      receive Ketofol (1 ketamine: 4 propofol) 0.5 mg/kg ketamine + 2 mg/kg propofol IV.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 16, 2017</start_date>
  <completion_date type="Anticipated">August 15, 2018</completion_date>
  <primary_completion_date type="Anticipated">June 15, 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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>double blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>incidence of desaturation</measure>
    <time_frame>up to 2 days after operation</time_frame>
    <description>when oxygen saturation below 90%</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Sedation</condition>
  <arm_group>
    <arm_group_label>Fentanyl</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group I (FP): will receive 0.5 µg/ kg fentanyl + 2 mg/ kg propofol IV.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ketamine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group II (KP): will receive 0.5 mg/kg ketamine + 2 mg/kg propofol IV.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fentanyl</intervention_name>
    <description>fentanyl used with propofol for sedation</description>
    <arm_group_label>Fentanyl</arm_group_label>
    <other_name>Fentanyl Citrate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketamine</intervention_name>
    <description>ketamine used with propofol for sedation</description>
    <arm_group_label>Ketamine</arm_group_label>
    <other_name>katalar</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pediatric patients undergoing diagnostic GIT endoscopy&#xD;
&#xD;
          -  ASA I-II&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Emergency endoscopy&#xD;
&#xD;
          -  Respiratory infection and hyperactive airways&#xD;
&#xD;
          -  History of serious adverse effects related to anesthetics (e.g. allergic reactions), a&#xD;
             family history of reactions to the study drugs&#xD;
&#xD;
          -  Morbid obesity, and neuropsychiatric disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mohamed Aly</last_name>
    <phone>00201062011126</phone>
    <email>galalm1967@yahoo.com</email>
  </overall_contact>
  <reference>
    <citation>Michaud L; Francophone Pediatric Hepatology, Gastroenterology, and Nutrition Group. Sedation for diagnostic upper gastrointestinal endoscopy: a survey of the Francophone Pediatric Hepatology, Gastroenterology, and Nutrition Group. Endoscopy. 2005 Feb;37(2):167-70. doi: 10.1055/s-2004-826144.</citation>
    <PMID>15692933</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>August 1, 2017</last_update_submitted>
  <last_update_submitted_qc>August 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mohamed galal aly</investigator_full_name>
    <investigator_title>Assistant Professor</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>


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/NCT03235609
org study id: 17100212
nct id: NCT03235609
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
comparison between propofol-fentanyl and propofol-ketamine for sedation in pediatric
      diagnostic gastrointestinal endoscopy.
It is a prospective double blinded controlled study that will be carried out on 60 pediatric
      patients undergoing GIT endoscopy; they will be divided into two groups of 30 patients each:-
      Group I (PF): will receive 0.5 µg/ kg fentanyl + 2 mg/ kg propofol IV. Group II (KF): will
      receive Ketofol (1 ketamine: 4 propofol) 0.5 mg/kg ketamine + 2 mg/kg propofol IV.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: double blind
measure: incidence of desaturation
time frame: up to 2 days after operation
description: when oxygen saturation below 90%
arm group label: Fentanyl
arm group type: Active Comparator
description: Group I (FP): will receive 0.5 µg/ kg fentanyl + 2 mg/ kg propofol IV.
arm group label: Ketamine
arm group type: Active Comparator
description: Group II (KP): will receive 0.5 mg/kg ketamine + 2 mg/kg propofol IV.
intervention type: Drug
intervention name: Fentanyl
description: fentanyl used with propofol for sedation
arm group label: Fentanyl
other name: Fentanyl Citrate
intervention type: Drug
intervention name: Ketamine
description: ketamine used with propofol for sedation
arm group label: Ketamine
other name: katalar
criteria: 
gender: All
minimum age: 6 Years
maximum age: 16 Years
healthy volunteers: No
last name: Mohamed Aly
phone: 00201062011126
email: galalm1967@yahoo.com
citation: Michaud L; Francophone Pediatric Hepatology, Gastroenterology, and Nutrition Group. Sedation for diagnostic upper gastrointestinal endoscopy: a survey of the Francophone Pediatric Hepatology, Gastroenterology, and Nutrition Group. Endoscopy. 2005 Feb;37(2):167-70. doi: 10.1055/s-2004-826144.
PMID: 15692933
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mohamed galal aly
investigator title: Assistant Professor
mesh term: Fentanyl
mesh term: Ketamine