<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/NCT03002792</url>
  </required_header>
  <id_info>
    <org_study_id>2014KTCL03_05</org_study_id>
    <nct_id>NCT03002792</nct_id>
  </id_info>
  <brief_title>Neurodevelopment Outcomes After Pediatric Dental Caries Treatment Under General Anaesthesia</brief_title>
  <official_title>Neurodevelopment Outcomes After Pediatric Dental Caries Treatment Under General Anaesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Air Force Military Medical University, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Air Force Military Medical University, China</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate whether early expose to general anaesthesia will&#xD;
      influence neurodevelopment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants, according to the state of illness and clinical requirements, assigned to&#xD;
      receive dental caries treatment with or without general anesthesia. During the follow-up,&#xD;
      various of neurodevelopment assessment will be done at specific timepoint to investigate&#xD;
      whether general anaesthesia will influence neurodevelopment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">June 2020</completion_date>
  <primary_completion_date type="Anticipated">June 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Full Scale Intelligence Quotient (IQ)</measure>
    <time_frame>24-28 weeks after enrollment</time_frame>
    <description>according to Wechsler Preschool and Primary Scale of Intelligence fourth edition (WPPSI-IV)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Verbal Comprehension Index</measure>
    <time_frame>24-28 weeks after enrollment</time_frame>
    <description>according to WPPSI-IV</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Spatial Index</measure>
    <time_frame>24-28 weeks after enrollment</time_frame>
    <description>according to WPPSI-IV</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fluid Spatial Index</measure>
    <time_frame>24-28 weeks after enrollment</time_frame>
    <description>according to WPPSI-IV</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Working Memory Index</measure>
    <time_frame>24-28 weeks after enrollment</time_frame>
    <description>according to WPPSI-IV</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Processing Speed Index</measure>
    <time_frame>24-28 weeks after enrollment</time_frame>
    <description>according to WPPSI-IV</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Executive Function</measure>
    <time_frame>24-28 weeks after enrollment</time_frame>
    <description>according to Behavior Rating Inventory of Executive Function-Preschool Version (BRIEF-P)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adaptive Behavior</measure>
    <time_frame>24-28 weeks after enrollment</time_frame>
    <description>according to Adaptive Behavior Assessment System second edition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emotion Comprehension</measure>
    <time_frame>24-28 weeks after enrollment</time_frame>
    <description>according to Test of Emotion Comprehension(TEC) (designed by Pons &amp; Harris ,2000)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">360</enrollment>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>general anesthesia</arm_group_label>
    <description>caries treatment under general anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>caries treatment only</arm_group_label>
    <description>caries treatment without general anesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>general anesthesia</intervention_name>
    <description>nitrous oxide, sevoflurane, propofol, cisatracurium, fentanyl for induction and maintenance with sevoflurane</description>
    <arm_group_label>general anesthesia</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients revieve carves treatment in Department of Pediatric Dentistry，School of&#xD;
        Stomatology, the Fourth Military Medical University&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Gestational age&gt;=36 weeks&#xD;
&#xD;
          -  American Society of Anesthesiologists（ASA） physical status Ⅰ or Ⅱ，with very limited&#xD;
             systemic disease.&#xD;
&#xD;
          -  Age&lt;=6 yr&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  did not provide research authorization；&#xD;
&#xD;
          -  unable to contact or inconvenient for follow-up;&#xD;
&#xD;
          -  hypersensitive to general anesthesia drug;&#xD;
&#xD;
          -  previous exposure to general anesthesia in utero;&#xD;
&#xD;
          -  previous exposure to general anesthesia as a neonate&#xD;
&#xD;
          -  previous exposure to psychotropic medication;&#xD;
&#xD;
          -  complications at birth such as low weigh, hypoxia, or cerebral edema;&#xD;
&#xD;
          -  any other known diseases may influence the neurodevelopment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hui Zhang, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>School of Stomatology, the Fourth Military Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hui Zhang, M.D.</last_name>
    <phone>(+86)029-84776119</phone>
    <email>zhanghuifmmua@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>School of Stomatology, the Fourth Military Medical University</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Xin Qi, Postgraduate</last_name>
      <phone>(+86)029-84776230</phone>
      <email>qixin-166@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Bing Liu, Master</last_name>
      <phone>(+86)029-84776230</phone>
      <email>adalb729@163.com</email>
    </contact_backup>
    <investigator>
      <last_name>Hui Zhang, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Guoliang Zhang, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Wei Wang, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Rui Lu, Master</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Lirong Liang, Postgraduate</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Zou X, Liu F, Zhang X, Patterson TA, Callicott R, Liu S, Hanig JP, Paule MG, Slikker W Jr, Wang C. Inhalation anesthetic-induced neuronal damage in the developing rhesus monkey. Neurotoxicol Teratol. 2011 Sep-Oct;33(5):592-7. doi: 10.1016/j.ntt.2011.06.003. Epub 2011 Jun 25.</citation>
    <PMID>21708249</PMID>
  </reference>
  <reference>
    <citation>Paule MG, Li M, Allen RR, Liu F, Zou X, Hotchkiss C, Hanig JP, Patterson TA, Slikker W Jr, Wang C. Ketamine anesthesia during the first week of life can cause long-lasting cognitive deficits in rhesus monkeys. Neurotoxicol Teratol. 2011 Mar-Apr;33(2):220-30. doi: 10.1016/j.ntt.2011.01.001. Epub 2011 Jan 15.</citation>
    <PMID>21241795</PMID>
  </reference>
  <reference>
    <citation>Shen X, Liu Y, Xu S, Zhao Q, Guo X, Shen R, Wang F. Early life exposure to sevoflurane impairs adulthood spatial memory in the rat. Neurotoxicology. 2013 Dec;39:45-56. doi: 10.1016/j.neuro.2013.08.007. Epub 2013 Aug 27.</citation>
    <PMID>23994303</PMID>
  </reference>
  <reference>
    <citation>Hansen TG, Pedersen JK, Henneberg SW, Pedersen DA, Murray JC, Morton NS, Christensen K. Academic performance in adolescence after inguinal hernia repair in infancy: a nationwide cohort study. Anesthesiology. 2011 May;114(5):1076-85. doi: 10.1097/ALN.0b013e31820e77a0.</citation>
    <PMID>21368654</PMID>
  </reference>
  <reference>
    <citation>Ing C, DiMaggio C, Whitehouse A, Hegarty MK, Brady J, von Ungern-Sternberg BS, Davidson A, Wood AJ, Li G, Sun LS. Long-term differences in language and cognitive function after childhood exposure to anesthesia. Pediatrics. 2012 Sep;130(3):e476-85. doi: 10.1542/peds.2011-3822. Epub 2012 Aug 20.</citation>
    <PMID>22908104</PMID>
  </reference>
  <reference>
    <citation>Wilder RT, Flick RP, Sprung J, Katusic SK, Barbaresi WJ, Mickelson C, Gleich SJ, Schroeder DR, Weaver AL, Warner DO. Early exposure to anesthesia and learning disabilities in a population-based birth cohort. Anesthesiology. 2009 Apr;110(4):796-804. doi: 10.1097/01.anes.0000344728.34332.5d.</citation>
    <PMID>19293700</PMID>
  </reference>
  <reference>
    <citation>Graham MR, Brownell M, Chateau DG, Dragan RD, Burchill C, Fransoo RR. Neurodevelopmental Assessment in Kindergarten in Children Exposed to General Anesthesia before the Age of 4 Years: A Retrospective Matched Cohort Study. Anesthesiology. 2016 Oct;125(4):667-677. doi: 10.1097/ALN.0000000000001245.</citation>
    <PMID>27655179</PMID>
  </reference>
  <reference>
    <citation>Sun LS, Li G, Miller TL, Salorio C, Byrne MW, Bellinger DC, Ing C, Park R, Radcliffe J, Hays SR, DiMaggio CJ, Cooper TJ, Rauh V, Maxwell LG, Youn A, McGowan FX. Association Between a Single General Anesthesia Exposure Before Age 36 Months and Neurocognitive Outcomes in Later Childhood. JAMA. 2016 Jun 7;315(21):2312-20. doi: 10.1001/jama.2016.6967.</citation>
    <PMID>27272582</PMID>
  </reference>
  <reference>
    <citation>Davidson AJ, Disma N, de Graaff JC, Withington DE, Dorris L, Bell G, Stargatt R, Bellinger DC, Schuster T, Arnup SJ, Hardy P, Hunt RW, Takagi MJ, Giribaldi G, Hartmann PL, Salvo I, Morton NS, von Ungern Sternberg BS, Locatelli BG, Wilton N, Lynn A, Thomas JJ, Polaner D, Bagshaw O, Szmuk P, Absalom AR, Frawley G, Berde C, Ormond GD, Marmor J, McCann ME; GAS consortium. Neurodevelopmental outcome at 2 years of age after general anaesthesia and awake-regional anaesthesia in infancy (GAS): an international multicentre, randomised controlled trial. Lancet. 2016 Jan 16;387(10015):239-50. doi: 10.1016/S0140-6736(15)00608-X. Epub 2015 Nov 4. Erratum In: Lancet. 2016 Jan 16;387(10015):228.</citation>
    <PMID>26507180</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 17, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 26, 2016</study_first_posted>
  <last_update_submitted>November 26, 2017</last_update_submitted>
  <last_update_submitted_qc>November 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Air Force Military Medical University, China</investigator_affiliation>
    <investigator_full_name>Hui Zhang</investigator_full_name>
    <investigator_title>M.D., Ph.D. Director and Professor, Department of Anaesthesiology, School of Stomatology</investigator_title>
  </responsible_party>
  <keyword>anesthesia</keyword>
  <keyword>neurodevelopment</keyword>
  <keyword>dental caries</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03002792
org study id: 2014KTCL03_05
nct id: NCT03002792
lead sponsor: 
has dmc: Yes
The purpose of this study is to investigate whether early expose to general anaesthesia will
      influence neurodevelopment.
Participants, according to the state of illness and clinical requirements, assigned to
      receive dental caries treatment with or without general anesthesia. During the follow-up,
      various of neurodevelopment assessment will be done at specific timepoint to investigate
      whether general anaesthesia will influence neurodevelopment.
observational model: Cohort
time perspective: Prospective
measure: Full Scale Intelligence Quotient (IQ)
time frame: 24-28 weeks after enrollment
description: according to Wechsler Preschool and Primary Scale of Intelligence fourth edition (WPPSI-IV)
measure: Verbal Comprehension Index
time frame: 24-28 weeks after enrollment
description: according to WPPSI-IV
measure: Visual Spatial Index
time frame: 24-28 weeks after enrollment
description: according to WPPSI-IV
measure: Fluid Spatial Index
time frame: 24-28 weeks after enrollment
description: according to WPPSI-IV
measure: Working Memory Index
time frame: 24-28 weeks after enrollment
description: according to WPPSI-IV
measure: Processing Speed Index
time frame: 24-28 weeks after enrollment
description: according to WPPSI-IV
measure: Executive Function
time frame: 24-28 weeks after enrollment
description: according to Behavior Rating Inventory of Executive Function-Preschool Version (BRIEF-P)
measure: Adaptive Behavior
time frame: 24-28 weeks after enrollment
description: according to Adaptive Behavior Assessment System second edition
measure: Emotion Comprehension
time frame: 24-28 weeks after enrollment
description: according to Test of Emotion Comprehension(TEC) (designed by Pons & Harris ,2000)
arm group label: general anesthesia
description: caries treatment under general anesthesia
arm group label: caries treatment only
description: caries treatment without general anesthesia
intervention type: Procedure
intervention name: general anesthesia
description: nitrous oxide, sevoflurane, propofol, cisatracurium, fentanyl for induction and maintenance with sevoflurane
arm group label: general anesthesia
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 6 Years
healthy volunteers: No
last name: Hui Zhang, M.D.
role: Study Director
affiliation: School of Stomatology, the Fourth Military Medical University
last name: Hui Zhang, M.D.
phone: (+86)029-84776119
email: zhanghuifmmua@163.com
facility: 
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: China
citation: Zou X, Liu F, Zhang X, Patterson TA, Callicott R, Liu S, Hanig JP, Paule MG, Slikker W Jr, Wang C. Inhalation anesthetic-induced neuronal damage in the developing rhesus monkey. Neurotoxicol Teratol. 2011 Sep-Oct;33(5):592-7. doi: 10.1016/j.ntt.2011.06.003. Epub 2011 Jun 25.
PMID: 21708249
citation: Paule MG, Li M, Allen RR, Liu F, Zou X, Hotchkiss C, Hanig JP, Patterson TA, Slikker W Jr, Wang C. Ketamine anesthesia during the first week of life can cause long-lasting cognitive deficits in rhesus monkeys. Neurotoxicol Teratol. 2011 Mar-Apr;33(2):220-30. doi: 10.1016/j.ntt.2011.01.001. Epub 2011 Jan 15.
PMID: 21241795
citation: Shen X, Liu Y, Xu S, Zhao Q, Guo X, Shen R, Wang F. Early life exposure to sevoflurane impairs adulthood spatial memory in the rat. Neurotoxicology. 2013 Dec;39:45-56. doi: 10.1016/j.neuro.2013.08.007. Epub 2013 Aug 27.
PMID: 23994303
citation: Hansen TG, Pedersen JK, Henneberg SW, Pedersen DA, Murray JC, Morton NS, Christensen K. Academic performance in adolescence after inguinal hernia repair in infancy: a nationwide cohort study. Anesthesiology. 2011 May;114(5):1076-85. doi: 10.1097/ALN.0b013e31820e77a0.
PMID: 21368654
citation: Ing C, DiMaggio C, Whitehouse A, Hegarty MK, Brady J, von Ungern-Sternberg BS, Davidson A, Wood AJ, Li G, Sun LS. Long-term differences in language and cognitive function after childhood exposure to anesthesia. Pediatrics. 2012 Sep;130(3):e476-85. doi: 10.1542/peds.2011-3822. Epub 2012 Aug 20.
PMID: 22908104
citation: Wilder RT, Flick RP, Sprung J, Katusic SK, Barbaresi WJ, Mickelson C, Gleich SJ, Schroeder DR, Weaver AL, Warner DO. Early exposure to anesthesia and learning disabilities in a population-based birth cohort. Anesthesiology. 2009 Apr;110(4):796-804. doi: 10.1097/01.anes.0000344728.34332.5d.
PMID: 19293700
citation: Graham MR, Brownell M, Chateau DG, Dragan RD, Burchill C, Fransoo RR. Neurodevelopmental Assessment in Kindergarten in Children Exposed to General Anesthesia before the Age of 4 Years: A Retrospective Matched Cohort Study. Anesthesiology. 2016 Oct;125(4):667-677. doi: 10.1097/ALN.0000000000001245.
PMID: 27655179
citation: Sun LS, Li G, Miller TL, Salorio C, Byrne MW, Bellinger DC, Ing C, Park R, Radcliffe J, Hays SR, DiMaggio CJ, Cooper TJ, Rauh V, Maxwell LG, Youn A, McGowan FX. Association Between a Single General Anesthesia Exposure Before Age 36 Months and Neurocognitive Outcomes in Later Childhood. JAMA. 2016 Jun 7;315(21):2312-20. doi: 10.1001/jama.2016.6967.
PMID: 27272582
citation: Davidson AJ, Disma N, de Graaff JC, Withington DE, Dorris L, Bell G, Stargatt R, Bellinger DC, Schuster T, Arnup SJ, Hardy P, Hunt RW, Takagi MJ, Giribaldi G, Hartmann PL, Salvo I, Morton NS, von Ungern Sternberg BS, Locatelli BG, Wilton N, Lynn A, Thomas JJ, Polaner D, Bagshaw O, Szmuk P, Absalom AR, Frawley G, Berde C, Ormond GD, Marmor J, McCann ME; GAS consortium. Neurodevelopmental outcome at 2 years of age after general anaesthesia and awake-regional anaesthesia in infancy (GAS): an international multicentre, randomised controlled trial. Lancet. 2016 Jan 16;387(10015):239-50. doi: 10.1016/S0140-6736(15)00608-X. Epub 2015 Nov 4. Erratum In: Lancet. 2016 Jan 16;387(10015):228.
PMID: 26507180
responsible party type: Principal Investigator
investigator affiliation: Air Force Military Medical University, China
investigator full name: Hui Zhang
investigator title: M.D., Ph.D. Director and Professor, Department of Anaesthesiology, School of Stomatology
mesh term: Dental Caries
mesh term: Anesthetics
sharing ipd: Undecided