<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/NCT03257800</url>
  </required_header>
  <id_info>
    <org_study_id>0925-0586</org_study_id>
    <nct_id>NCT03257800</nct_id>
  </id_info>
  <brief_title>Laryngeal Mask Insertion Conditions And Hemodynamic Effects</brief_title>
  <official_title>Laryngeal Mask Insertion Conditions And Hemodynamic Effects After Propofol And Ketamine-Propofol Co-induction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Leila mansali stambouli</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Monastir</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This interventional double-blind, randomized trial has included120 children of American&#xD;
      Society of Anesthesiologist (ASA) physical status I or II aged between 1and 8 years of either&#xD;
      sex, scheduled for outpatient minor surgery under general anesthesia.This study examined&#xD;
      whether co-induction with ketamine-propofol enhance laryngeal mask airway (LMA) insertion&#xD;
      conditions and preserve hemodynamic state in patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to compare two anesthesia protocols: propofol induction with or without a&#xD;
      prior injection of ketamine, in term of LMA insertion conditions(favorable= satisfactory or&#xD;
      unfavorable= unsatisfactory ) and hemodynamic effects (decrease of 20 % from baseline of&#xD;
      blood pressure and heart rate).&#xD;
&#xD;
      The conditions of LMA insertion have been assessed in each study group by an experimented&#xD;
      anesthesiologist, who was unaware of the treatment group assignment. Conditions were&#xD;
      considered satisfactory, if the 4 following criteria were acceptable: the jaw was relaxed,&#xD;
      there was no coughing, swallowing and no limb movement, and then the LMA was inserted. When&#xD;
      the investigators save at least one unacceptable of these criteria, conditions were&#xD;
      considered to be unsatisfactory and thereafter anesthesia was deepened with supplemental dose&#xD;
      of propofol 1mg.kg-¹ and 1 minute later a reinsertion was attempted. The total number of&#xD;
      attempts at LMA insertion was recorded. Children trachea was intubated after 3 failed&#xD;
      attempts of LMA insertion, and then patient was excluded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2013</start_date>
  <completion_date type="Actual">December 31, 2013</completion_date>
  <primary_completion_date type="Actual">December 30, 2013</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>
    <intervention_model_description>Randomized, controlled and double blind assignment</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>LMA insertion conditions</measure>
    <time_frame>2 minutes</time_frame>
    <description>satisfactory conditions of LMA insertion are defined as when 4 criteria were acceptable: jaw relaxation, no coughing or swallowing and no limb movement.&#xD;
unsatisfactory conditions of LMA insertion is defined as when there's at least one unacceptable of these criteria</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>hemodynamic effects</measure>
    <time_frame>from Baseline period until 10 minutes after LMA insertion</time_frame>
    <description>mean blood pressure (MAP) in mmHg . Heart Rate (HR) in beats per minute (time frame: from baseline to LMA insertion)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>delirium</measure>
    <time_frame>from awake until 30 min after emergence</time_frame>
    <description>Emergence delirium was assessed by the Pediatric Anesthesia Emergence Delirium Scale (PAED) and was defined as a PAED score &gt;10</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Laryngeal Masks</condition>
  <arm_group>
    <arm_group_label>ketamine-propofol group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ketamine (50mg/ml) at 0.5 mg.kg-1 was injected intravenously 1min prior 3 mgkg-1 of propofol and 1 min before LMA insertion in Ketamine-propofol group.&#xD;
sevoflurane 6-7% was used on vaporizer setting with 50% nitrous oxide in oxgen prior intravenous anesthesia. The loss of eyelash reflex was considered as the desired end point for induction.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>propofol group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>0,9% saline solution ( Placebo ) at the same volume as ketamine (50mg/ml) was injected intravenously 1min prior propofol 3 mg.kg-1 and 1 min before LMA insertion in propofol group.&#xD;
sevoflurane 6-7% was used on vaporizer setting with 50% nitrous oxide in oxgen prior intravenous anesthesia. The loss of eyelash reflex was considered as the desired end point for induction.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketamine</intervention_name>
    <description>Ketamine 0,5mg.kg-¹was injected intravenously one minute prior propofol 3mg.kg-¹ and one minute before LMA insertion in Ketamine-propofol group</description>
    <arm_group_label>ketamine-propofol group</arm_group_label>
    <other_name>sevoflurane, nitrous oxide (N2O)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>The control group which received intravenously the same volume with normal saline one minute prior propofol 3mg.kg-¹ and 1 min before LMA insertion in propofol group</description>
    <arm_group_label>propofol group</arm_group_label>
    <other_name>sevoflurane, N2O</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA physical status I or II who were scheduled to minor elective ambulatory surgery&#xD;
             (e.g. inguinal hernia, undescended testes, umbilical hernia) performed by experienced&#xD;
             surgeon under general anesthesia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with full stomach&#xD;
&#xD;
          -  A history of gastric reflux&#xD;
&#xD;
          -  A history of convulsions, cardiovascular or neuromuscular disease&#xD;
&#xD;
          -  Allergies to the study drugs&#xD;
&#xD;
          -  obese children&#xD;
&#xD;
          -  suspected difficult airway and hyper-reactive airway disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>leila Mansali Stambouli, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>university Hospital of Fattouma Bourguiba, Monastir, TUNISIA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital of Fattouma Bourguiba</name>
      <address>
        <city>Monastir</city>
        <zip>5000</zip>
        <country>Tunisia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Tunisia</country>
  </location_countries>
  <reference>
    <citation>Goel S, Bhardwaj N, Jain K. Efficacy of ketamine and midazolam as co-induction agents with propofol for laryngeal mask insertion in children. Paediatr Anaesth. 2008 Jul;18(7):628-34. doi: 10.1111/j.1460-9592.2008.02563.x. Epub 2008 May 8.</citation>
    <PMID>18482245</PMID>
  </reference>
  <reference>
    <citation>Singh R, Arora M, Vajifdar H. Randomized double-blind comparison of ketamine-propofol and fentanyl-propofol for the insertion of laryngeal mask airway in children. J Anaesthesiol Clin Pharmacol. 2011 Jan;27(1):91-6.</citation>
    <PMID>21804715</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>August 18, 2017</last_update_submitted>
  <last_update_submitted_qc>August 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Monastir</investigator_affiliation>
    <investigator_full_name>Leila mansali stambouli</investigator_full_name>
    <investigator_title>Principal Investigator and Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>ketamine</keyword>
  <keyword>Propofol</keyword>
  <keyword>laryngeal masks</keyword>
  <keyword>anesthesia</keyword>
  <keyword>child</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ketamine</mesh_term>
    <mesh_term>Nitrous Oxide</mesh_term>
    <mesh_term>Sevoflurane</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/NCT03257800
org study id: 0925-0586
nct id: NCT03257800
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This interventional double-blind, randomized trial has included120 children of American
      Society of Anesthesiologist (ASA) physical status I or II aged between 1and 8 years of either
      sex, scheduled for outpatient minor surgery under general anesthesia.This study examined
      whether co-induction with ketamine-propofol enhance laryngeal mask airway (LMA) insertion
      conditions and preserve hemodynamic state in patients.
This study aims to compare two anesthesia protocols: propofol induction with or without a
      prior injection of ketamine, in term of LMA insertion conditions(favorable= satisfactory or
      unfavorable= unsatisfactory ) and hemodynamic effects (decrease of 20 % from baseline of
      blood pressure and heart rate).

      The conditions of LMA insertion have been assessed in each study group by an experimented
      anesthesiologist, who was unaware of the treatment group assignment. Conditions were
      considered satisfactory, if the 4 following criteria were acceptable: the jaw was relaxed,
      there was no coughing, swallowing and no limb movement, and then the LMA was inserted. When
      the investigators save at least one unacceptable of these criteria, conditions were
      considered to be unsatisfactory and thereafter anesthesia was deepened with supplemental dose
      of propofol 1mg.kg-¹ and 1 minute later a reinsertion was attempted. The total number of
      attempts at LMA insertion was recorded. Children trachea was intubated after 3 failed
      attempts of LMA insertion, and then patient was excluded.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, controlled and double blind assignment
primary purpose: Other
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: LMA insertion conditions
time frame: 2 minutes
description: satisfactory conditions of LMA insertion are defined as when 4 criteria were acceptable: jaw relaxation, no coughing or swallowing and no limb movement.
unsatisfactory conditions of LMA insertion is defined as when there's at least one unacceptable of these criteria
measure: hemodynamic effects
time frame: from Baseline period until 10 minutes after LMA insertion
description: mean blood pressure (MAP) in mmHg . Heart Rate (HR) in beats per minute (time frame: from baseline to LMA insertion)
measure: delirium
time frame: from awake until 30 min after emergence
description: Emergence delirium was assessed by the Pediatric Anesthesia Emergence Delirium Scale (PAED) and was defined as a PAED score >10
arm group label: ketamine-propofol group
arm group type: Active Comparator
description: Ketamine (50mg/ml) at 0.5 mg.kg-1 was injected intravenously 1min prior 3 mgkg-1 of propofol and 1 min before LMA insertion in Ketamine-propofol group.
sevoflurane 6-7% was used on vaporizer setting with 50% nitrous oxide in oxgen prior intravenous anesthesia. The loss of eyelash reflex was considered as the desired end point for induction.
arm group label: propofol group
arm group type: Placebo Comparator
description: 0,9% saline solution ( Placebo ) at the same volume as ketamine (50mg/ml) was injected intravenously 1min prior propofol 3 mg.kg-1 and 1 min before LMA insertion in propofol group.
sevoflurane 6-7% was used on vaporizer setting with 50% nitrous oxide in oxgen prior intravenous anesthesia. The loss of eyelash reflex was considered as the desired end point for induction.
intervention type: Drug
intervention name: Ketamine
description: Ketamine 0,5mg.kg-¹was injected intravenously one minute prior propofol 3mg.kg-¹ and one minute before LMA insertion in Ketamine-propofol group
arm group label: ketamine-propofol group
other name: sevoflurane, nitrous oxide (N2O)
intervention type: Drug
intervention name: placebo
description: The control group which received intravenously the same volume with normal saline one minute prior propofol 3mg.kg-¹ and 1 min before LMA insertion in propofol group
arm group label: propofol group
other name: sevoflurane, N2O
criteria: 
gender: All
minimum age: 1 Year
maximum age: 8 Years
healthy volunteers: No
last name: leila Mansali Stambouli, MD PhD
role: Principal Investigator
affiliation: university Hospital of Fattouma Bourguiba, Monastir, TUNISIA
facility: 
country: Tunisia
citation: Goel S, Bhardwaj N, Jain K. Efficacy of ketamine and midazolam as co-induction agents with propofol for laryngeal mask insertion in children. Paediatr Anaesth. 2008 Jul;18(7):628-34. doi: 10.1111/j.1460-9592.2008.02563.x. Epub 2008 May 8.
PMID: 18482245
citation: Singh R, Arora M, Vajifdar H. Randomized double-blind comparison of ketamine-propofol and fentanyl-propofol for the insertion of laryngeal mask airway in children. J Anaesthesiol Clin Pharmacol. 2011 Jan;27(1):91-6.
PMID: 21804715
responsible party type: Sponsor-Investigator
investigator affiliation: University of Monastir
investigator full name: Leila mansali stambouli
investigator title: Principal Investigator and Clinical Professor
mesh term: Ketamine
mesh term: Nitrous Oxide
mesh term: Sevoflurane
sharing ipd: No