<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/NCT03254303</url>
  </required_header>
  <id_info>
    <org_study_id>OMB: 0925-0586</org_study_id>
    <nct_id>NCT03254303</nct_id>
  </id_info>
  <brief_title>Intravenous Cannulation In Children During Sevoflurane Induction</brief_title>
  <official_title>Intravenous Cannulation In Children During Sevoflurane Induction: Which Time is Adequate</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 simple-blind,randomized trial has included 90 children of American&#xD;
      Society of Anesthesiologist (ASA) physical status I or II aged between 1 to 12 years of&#xD;
      either sex, scheduled for for outpatient minor surgery under general anesthesia. This study&#xD;
      examined whether one should make iv attempts during the early induction period (at 60&#xD;
      seconds) or lately (90 or 120 s) and waiting until the child receives additional sevoflurane&#xD;
      inhalation anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We conducted a prospective randomized study, after obtaining Institutional review board&#xD;
      approval, which didn't require written parental consent. Children age 1-12 years, undergoing&#xD;
      elective general anesthesia via an inhalation induction were randomized to one of three&#xD;
      groups of 30 patients each one, for iv placement, either 60s (group E), 90 or 120 s (group L)&#xD;
      following loss of lid reflex. Movement on iv placement and incidence of laryngospasm were&#xD;
      determined. Difficulty with iv placement was also recorded. Statistical analysis included&#xD;
      contingency testing, ANOVA, and non parametric testing. A P-value &lt;0.05 was considered&#xD;
      significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2016</start_date>
  <completion_date type="Actual">October 31, 2016</completion_date>
  <primary_completion_date type="Actual">October 31, 2016</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>Crossover Assignment</intervention_model>
    <intervention_model_description>randomized and crossover assignemnt</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>particippant, investigator, outcomes assessor</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Success of intravenous insertion</measure>
    <time_frame>from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds</time_frame>
    <description>success insertion of intravenous cannula was achieved at the first attempt less than 30 seconds</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>limb movement</measure>
    <time_frame>from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds</time_frame>
    <description>The movement was classified using the scale:&#xD;
(0 No movement, 1 movement) The incidence of laryngospasm was defined as the sudden complete or partial loss of air exchange with concurrent loss of a capnographic wave.&#xD;
The movement was classified using the scale:&#xD;
(0 No movement, 1 movement) The incidence of laryngospasm was defined as the sudden complete or partial loss of air exchange with concurrent loss of a capnographic wave.&#xD;
• The movement was classified using the scale: (0 No movement, 1 movement)&#xD;
• The movement was classified using the scale: (0 No movement, 1 movement) The limb movement was classified using the scale:0 No movement, 1 movement)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>laryngospasm</measure>
    <time_frame>from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds</time_frame>
    <description>laryngospasm was defined as the sudden complete or partial loss of air exchange with concurrent loss of a capnographic wave.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Catheterization</condition>
  <arm_group>
    <arm_group_label>60s (group E)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The Time of catheterization at 60s (group E) was applied in this study group,after sevoflurane inhalation induction, 30 children have a catheterization after a time of 60 seconds following the eye closure and the loss of lid reflex.Difficulty with intravenous catheterization, limb movement and laryngospasm were recorded.Difficulty of catheterization in group 60 s</description>
  </arm_group>
  <arm_group>
    <arm_group_label>90s (groupe L)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>In this study group,after sevoflurane inhalation induction, 30 children have a catheterization after a time of 90 seconds following the eye closure and the loss of lid reflex.Difficulty with intravenous catheterization, limb movement and laryngospasm were recorded.Difficulty of catheterization in group 90 s</description>
  </arm_group>
  <arm_group>
    <arm_group_label>120s (groupe L)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>In this study group,after sevoflurane inhalation induction, 30 children have a catheterization after a time of 120 seconds following the eye closure and the loss of lid reflex.Difficulty with intravenous catheterization, limb movement and laryngospasm were recorded.Difficulty of catheterization in group 120 s</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Difficulty of catheterization in group 60 s</intervention_name>
    <arm_group_label>60s (group E)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Difficulty of catheterization in group 90 s</intervention_name>
    <arm_group_label>90s (groupe L)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Difficulty of catheterization in group 120 s</intervention_name>
    <arm_group_label>120s (groupe L)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  children with American Society of Anesthesiologist (ASA) physical status I or II&#xD;
&#xD;
          -  age between 1 and 12 years of either sex,&#xD;
&#xD;
          -  were scheduled for outpatient minor surgery under general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt;1 and &gt;12 years&#xD;
&#xD;
          -  patients with full stomach&#xD;
&#xD;
          -  a history of gastric reflux&#xD;
&#xD;
          -  history of convulsions, cardiovascular or neuromuscular disease&#xD;
&#xD;
          -  suspected difficult airway and hyper-reactive airway disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>12 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>
  <reference>
    <citation>Choudhry DK, Stayer SA, Schwartz RE, Pasquariello CA. Early intravenous cannulation in children during inhalational induction of anaesthesia. Paediatr Anaesth. 1998;8(2):123-6. doi: 10.1046/j.1460-9592.1998.00731.x.</citation>
    <PMID>9549737</PMID>
  </reference>
  <results_reference>
    <citation>Schwartz D, Connelly NR, Gutta S, Freeman K, Gibson C. Early intravenous cannulation in children during sevoflurane induction. Paediatr Anaesth. 2004 Oct;14(10):820-4. doi: 10.1111/j.1460-9592.2004.01315.x.</citation>
    <PMID>15385009</PMID>
  </results_reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>August 17, 2017</last_update_submitted>
  <last_update_submitted_qc>August 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 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>Sevoflurane, Catheterization, Anesthetics Inhalation, child</keyword>
  <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/NCT03254303
org study id: OMB: 0925-0586
nct id: NCT03254303
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This interventional simple-blind,randomized trial has included 90 children of American
      Society of Anesthesiologist (ASA) physical status I or II aged between 1 to 12 years of
      either sex, scheduled for for outpatient minor surgery under general anesthesia. This study
      examined whether one should make iv attempts during the early induction period (at 60
      seconds) or lately (90 or 120 s) and waiting until the child receives additional sevoflurane
      inhalation anesthesia.
We conducted a prospective randomized study, after obtaining Institutional review board
      approval, which didn't require written parental consent. Children age 1-12 years, undergoing
      elective general anesthesia via an inhalation induction were randomized to one of three
      groups of 30 patients each one, for iv placement, either 60s (group E), 90 or 120 s (group L)
      following loss of lid reflex. Movement on iv placement and incidence of laryngospasm were
      determined. Difficulty with iv placement was also recorded. Statistical analysis included
      contingency testing, ANOVA, and non parametric testing. A P-value <0.05 was considered
      significant.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: randomized and crossover assignemnt
primary purpose: Other
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: particippant, investigator, outcomes assessor
measure: Success of intravenous insertion
time frame: from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds
description: success insertion of intravenous cannula was achieved at the first attempt less than 30 seconds
measure: limb movement
time frame: from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds
description: The movement was classified using the scale:
(0 No movement, 1 movement) The incidence of laryngospasm was defined as the sudden complete or partial loss of air exchange with concurrent loss of a capnographic wave.
The movement was classified using the scale:
(0 No movement, 1 movement) The incidence of laryngospasm was defined as the sudden complete or partial loss of air exchange with concurrent loss of a capnographic wave.
• The movement was classified using the scale: (0 No movement, 1 movement)
• The movement was classified using the scale: (0 No movement, 1 movement) The limb movement was classified using the scale:0 No movement, 1 movement)
measure: laryngospasm
time frame: from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds
description: laryngospasm was defined as the sudden complete or partial loss of air exchange with concurrent loss of a capnographic wave.
arm group label: 60s (group E)
arm group type: Other
description: The Time of catheterization at 60s (group E) was applied in this study group,after sevoflurane inhalation induction, 30 children have a catheterization after a time of 60 seconds following the eye closure and the loss of lid reflex.Difficulty with intravenous catheterization, limb movement and laryngospasm were recorded.Difficulty of catheterization in group 60 s
arm group label: 90s (groupe L)
arm group type: Other
description: In this study group,after sevoflurane inhalation induction, 30 children have a catheterization after a time of 90 seconds following the eye closure and the loss of lid reflex.Difficulty with intravenous catheterization, limb movement and laryngospasm were recorded.Difficulty of catheterization in group 90 s
arm group label: 120s (groupe L)
arm group type: Other
description: In this study group,after sevoflurane inhalation induction, 30 children have a catheterization after a time of 120 seconds following the eye closure and the loss of lid reflex.Difficulty with intravenous catheterization, limb movement and laryngospasm were recorded.Difficulty of catheterization in group 120 s
intervention type: Other
intervention name: Difficulty of catheterization in group 60 s
arm group label: 60s (group E)
intervention type: Other
intervention name: Difficulty of catheterization in group 90 s
arm group label: 90s (groupe L)
intervention type: Other
intervention name: Difficulty of catheterization in group 120 s
arm group label: 120s (groupe L)
criteria: 
gender: All
minimum age: 1 Year
maximum age: 12 Years
healthy volunteers: No
last name: leila Mansali Stambouli, MD PhD
role: Principal Investigator
affiliation: University Hospital of Fattouma Bourguiba Monastir TUNISIA
citation: Choudhry DK, Stayer SA, Schwartz RE, Pasquariello CA. Early intravenous cannulation in children during inhalational induction of anaesthesia. Paediatr Anaesth. 1998;8(2):123-6. doi: 10.1046/j.1460-9592.1998.00731.x.
PMID: 9549737
citation: Schwartz D, Connelly NR, Gutta S, Freeman K, Gibson C. Early intravenous cannulation in children during sevoflurane induction. Paediatr Anaesth. 2004 Oct;14(10):820-4. doi: 10.1111/j.1460-9592.2004.01315.x.
PMID: 15385009
responsible party type: Sponsor-Investigator
investigator affiliation: University of Monastir
investigator full name: Leila mansali stambouli
investigator title: Principal Investigator and Clinical Professor
sharing ipd: No