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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| general anesthesia | caries treatment under general anesthesia |
| |
| caries treatment only | caries treatment without general anesthesia |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| general anesthesia | Procedure | nitrous oxide, sevoflurane, propofol, cisatracurium, fentanyl for induction and maintenance with sevoflurane |
|
| Measure | Description | Time Frame |
|---|---|---|
| Full Scale Intelligence Quotient (IQ) | according to Wechsler Preschool and Primary Scale of Intelligence fourth edition (WPPSI-IV) | 24-28 weeks after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Verbal Comprehension Index | according to WPPSI-IV | 24-28 weeks after enrollment |
| Visual Spatial Index | according to WPPSI-IV | 24-28 weeks after enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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Patients revieve carves treatment in Department of Pediatric Dentistry,School of Stomatology, the Fourth Military Medical University
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hui Zhang, M.D. | Contact | (+86)029-84776119 | zhanghuifmmua@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Hui Zhang, M.D. | School of Stomatology, the Fourth Military Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Stomatology, the Fourth Military Medical University | Xi'an | Shaanxi | 710032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21708249 | Background | 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. | |
| 21241795 | Background | 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. |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D000768 | Anesthesia, General |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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| Fluid Spatial Index | according to WPPSI-IV | 24-28 weeks after enrollment |
| Working Memory Index | according to WPPSI-IV | 24-28 weeks after enrollment |
| Processing Speed Index | according to WPPSI-IV | 24-28 weeks after enrollment |
| Executive Function | according to Behavior Rating Inventory of Executive Function-Preschool Version (BRIEF-P) | 24-28 weeks after enrollment |
| Adaptive Behavior | according to Adaptive Behavior Assessment System second edition | 24-28 weeks after enrollment |
| Emotion Comprehension | according to Test of Emotion Comprehension(TEC) (designed by Pons & Harris ,2000) | 24-28 weeks after enrollment |
| 23994303 | Background | 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. |
| 21368654 | Background | 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. |
| 22908104 | Background | 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. |
| 19293700 | Background | 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. |
| 27655179 | Background | 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. |
| 27272582 | Background | 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. |
| 26507180 | Background | 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. |