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AnesthesiaNCT03002792

Neurodevelopment Outcomes After Pediatric Dental Caries Treatment Under General Anaesthesia

An observational study of Anesthesia, run by Air Force Military Medical University, China at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 2 to 6 years
Conditions the study is for
Anesthesia
What is being tested?
general anesthesia
Type of treatment
Surgery or procedure
How many people
360 participants
Where
1 siteChina
Study dates
Jan 2017to Jun 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 6 years
  • All sexes
  • No healthy volunteers
  • Child

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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Hui Zhang, M.D. contact

(+86)029-84776119

zhanghuifmmua@163.com

China1 site

  • School of Stomatology, the Fourth Military Medical University

    Xi'an, Shaanxi, 710032

    Xin Qi, Postgraduate, (+86)029-84776230, qixin-166@163.com

    Bing Liu, Master, (+86)029-84776230, adalb729@163.com

Other trials in China

About this study

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

Read the 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.

Conditions
Anesthesia
Being tested
general anesthesia
Keywords
anesthesia, neurodevelopment, dental caries
Medical subject headings
Dental Caries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • general anesthesiaProcedure or surgery

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

Study groups in NCT03002792
Study groupRoleWhat they receive
general anesthesiacaries treatment under general anesthesia
Receives: Procedure: general anesthesia
caries treatment onlycaries treatment without general anesthesia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Full Scale Intelligence Quotient (IQ)

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

    Measured: 24-28 weeks after enrollment

Secondary outcomes (8)

  1. Verbal Comprehension Index

    according to WPPSI-IV

    Measured: 24-28 weeks after enrollment

  2. Visual Spatial Index

    according to WPPSI-IV

    Measured: 24-28 weeks after enrollment

  3. Fluid Spatial Index

    according to WPPSI-IV

    Measured: 24-28 weeks after enrollment

  4. Working Memory Index

    according to WPPSI-IV

    Measured: 24-28 weeks after enrollment

  5. Processing Speed Index

    according to WPPSI-IV

    Measured: 24-28 weeks after enrollment

  6. Executive Function

    according to Behavior Rating Inventory of Executive Function-Preschool Version (BRIEF-P)

    Measured: 24-28 weeks after enrollment

  7. Adaptive Behavior

    according to Adaptive Behavior Assessment System second edition

    Measured: 24-28 weeks after enrollment

  8. Emotion Comprehension

    according to Test of Emotion Comprehension(TEC) (designed by Pons \& Harris ,2000)

    Measured: 24-28 weeks after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2016 (estimated)
  2. Study startJan 2017
  3. Primary completionJun 2018 (estimated)
  4. Study completionJun 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03002792
Sponsor's protocol ID
2014KTCL03_05
Status last verified
Jan 2017
First submitted
17 Dec 2016
Last updated
28 Nov 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 21708249

  • 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.

    PubMed 21241795

  • 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.

    PubMed 23994303

  • 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.

    PubMed 21368654

  • 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.

    PubMed 22908104

  • 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.

    PubMed 19293700

  • 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.

    PubMed 27655179

  • 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.

    PubMed 27272582

  • 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.

    PubMed 26507180

Questions about this trial

What is this clinical trial studying?

An observational study of Anesthesia, run by Air Force Military Medical University, China at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hui Zhang, M.D. ((+86)029-84776119, zhanghuifmmua@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Full Scale Intelligence Quotient (IQ) (time frame: 24-28 weeks after enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03002792, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2017.

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