Neurodevelopment Outcomes After Pediatric Dental Caries Treatment Under General Anaesthesia

Anesthesia Clinical Trial

Official title:

Neurodevelopment Outcomes After Pediatric Dental Caries Treatment Under General Anaesthesia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03002792
• Other study ID #: 2014KTCL03_05
• Status: Not yet recruiting
• Phase: N/A
• First received: December 17, 2016
• Last updated: November 26, 2017
• Start date: January 2017
• Est. completion date: June 2020

Study information

• Verified date: January 2017
• Source: Fourth Military Medical University
• Contact: Hui Zhang, M.D.
• Phone: (+86)029-84776119
• Email: zhanghuifmmua[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 360
• Est. completion date: June 2020
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

Inclusion Criteria:

• Gestational age>=36 weeks

• American Society of Anesthesiologists(ASA) physical status ? or ?,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

Related Conditions & MeSH terms

• Anesthesia
• Dental Caries

Intervention

Procedure:
• general anesthesia
nitrous oxide, sevoflurane, propofol, cisatracurium, fentanyl for induction and maintenance with sevoflurane

Locations

Country	Name	City	State
China	School of Stomatology, the Fourth Military Medical University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

References & Publications (9)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Full Scale Intelligence Quotient (IQ)	according to Wechsler Preschool and Primary Scale of Intelligence fourth edition (WPPSI-IV)	24-28 weeks after enrollment
Secondary	Verbal Comprehension Index	according to WPPSI-IV	24-28 weeks after enrollment
Secondary	Visual Spatial Index	according to WPPSI-IV	24-28 weeks after enrollment
Secondary	Fluid Spatial Index	according to WPPSI-IV	24-28 weeks after enrollment
Secondary	Working Memory Index	according to WPPSI-IV	24-28 weeks after enrollment
Secondary	Processing Speed Index	according to WPPSI-IV	24-28 weeks after enrollment
Secondary	Executive Function	according to Behavior Rating Inventory of Executive Function-Preschool Version (BRIEF-P)	24-28 weeks after enrollment
Secondary	Adaptive Behavior	according to Adaptive Behavior Assessment System second edition	24-28 weeks after enrollment
Secondary	Emotion Comprehension	according to Test of Emotion Comprehension(TEC) (designed by Pons & Harris ,2000)	24-28 weeks after enrollment