NCT03002792

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
360

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 26, 2016

Completed
6 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

November 28, 2017

Status Verified

January 1, 2017

Enrollment Period

1.4 years

First QC Date

December 17, 2016

Last Update Submit

November 26, 2017

Conditions

Anesthesia

Keywords

anesthesianeurodevelopmentdental caries

Outcome Measures

Primary Outcomes (1)

  • Full Scale Intelligence Quotient (IQ)

    according to Wechsler Preschool and Primary Scale of Intelligence fourth edition (WPPSI-IV)

    24-28 weeks after enrollment

Secondary Outcomes (8)

  • Verbal Comprehension Index

    24-28 weeks after enrollment

  • Visual Spatial Index

    24-28 weeks after enrollment

  • Fluid Spatial Index

    24-28 weeks after enrollment

  • Working Memory Index

    24-28 weeks after enrollment

  • Processing Speed Index

    24-28 weeks after enrollment

  • +3 more secondary outcomes

Study Arms (2)

general anesthesia

caries treatment under general anesthesia

Procedure: general anesthesia

caries treatment only

caries treatment without general anesthesia

Interventions

general anesthesiaPROCEDURE

nitrous oxide, sevoflurane, propofol, cisatracurium, fentanyl for induction and maintenance with sevoflurane

general anesthesia

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patients revieve carves treatment in Department of Pediatric Dentistry，School of Stomatology, the Fourth Military Medical University

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Stomatology, the Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

Location

Related Publications (9)

  • 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: 21708249BACKGROUND

  • 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: 21241795BACKGROUND

  • 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: 23994303BACKGROUND

  • 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: 21368654BACKGROUND

  • 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: 22908104BACKGROUND

  • 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: 19293700BACKGROUND

  • 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: 27655179BACKGROUND

  • 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: 27272582BACKGROUND

  • 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.

    PMID: 26507180BACKGROUND

MeSH Terms

Conditions

Dental Caries

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Officials

  • Hui Zhang, M.D.

    School of Stomatology, the Fourth Military Medical University

    STUDY DIRECTOR

Central Study Contacts

Hui Zhang, M.D.

CONTACT

(+86)029-84776119zhanghuifmmua@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.D. Director and Professor, Department of Anaesthesiology, School of Stomatology

Study Record Dates

First Submitted

December 17, 2016

First Posted

December 26, 2016

Study Start

January 1, 2017

Primary Completion

June 1, 2018

Study Completion

June 1, 2020

Last Updated

November 28, 2017

Record last verified: 2017-01

Locations

CN(1)