Clinical trial NCT03002792: Neurodevelopment Outcomes After Pediatric Dental Caries Treatment Under General Anaesthesia
Official title: Neurodevelopment Outcomes After Pediatric Dental Caries Treatment Under General Anaesthesia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anesthesia
Keywords: anesthesia
neurodevelopment
dental caries
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2016-12-26
Enrollment: 360
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients revieve carves treatment in Department of Pediatric Dentistry，School of Stomatology, the Fourth Military Medical University

Brief summary: The purpose of this study is to investigate whether early expose to general anaesthesia will influence neurodevelopment.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Gestational age\>=36 weeks
* American Society of Anesthesiologists（ASA） physical status Ⅰ or Ⅱ，with very limited systemic disease.
* Age\<=6 yr

Exclusion Criteria:

* did not provide research authorization；
* unable to contact or inconvenient for follow-up;
* hypersensitive to general anesthesia drug;
* previous exposure to general anesthesia in utero;
* previous exposure to general anesthesia as a neonate
* previous exposure to psychotropic medication;
* complications at birth such as low weigh, hypoxia, or cerebral edema;
* any other known diseases may influence the neurodevelopment

Primary outcomes:
measure: Full Scale Intelligence Quotient (IQ)
timeFrame: 24-28 weeks after enrollment
Secondary outcomes:
measure: Verbal Comprehension Index
timeFrame: 24-28 weeks after enrollment
measure: Visual Spatial Index
timeFrame: 24-28 weeks after enrollment
measure: Fluid Spatial Index
timeFrame: 24-28 weeks after enrollment
measure: Working Memory Index
timeFrame: 24-28 weeks after enrollment
measure: Processing Speed Index
timeFrame: 24-28 weeks after enrollment
measure: Executive Function
timeFrame: 24-28 weeks after enrollment
measure: Adaptive Behavior
timeFrame: 24-28 weeks after enrollment
measure: Emotion Comprehension
timeFrame: 24-28 weeks after enrollment
Other outcomes:
Locations:
city: Xi'an
country: China
facility: School of Stomatology, the Fourth Military Medical University
state: Shaanxi
Study officials:
affiliation: School of Stomatology, the Fourth Military Medical University
name: Hui Zhang, M.D.
role: STUDY_DIRECTOR
References:
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: 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: 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: 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: 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: 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: 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: 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: 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.