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| Name | Class |
|---|---|
| Shanghai Children's Medical Center | OTHER |
| Children's Hospital of Fudan University | OTHER |
| Shanghai Children's Hospital | OTHER |
| Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University |
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Numerous preclinical evidence has confirmed that most commonly-used general anesthetics can affect neurodevelopment of young animals adversely, causing both structural defect of brain and cognitive impairment. However, it is unclear at present whether such effect would also occur to children exposed to general anesthesia in their early life. Several observational clinical studies and one interventional clinical trial indicated that short-time general anesthesia less than 80 minutes might be safe to cognitive development. Concerning long-time and/or multiple anesthesia exposure, some studies supported its association with long-term cognitive defects, while other studies did not. These studies are mainly retrospective or ambirectional researches. We have designed a prospective, multicenter cohort study to examine the neurodevelopment of infants exposed to anesthesia before age 2 in the first year after surgery, and compare the neurodevelopment status of infants exposed to anesthesia less than 3 hours and those more than 3 hours. The Gesell Developmental Inventory (GDI) and several neuropsychological testing batteries will be used. The anticipated outcome of the study will add reliable evidence from Asians to elucidate the relationship of anesthesia and long-term neurodevelopment of infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Long-time anesthesia exposure | Infants receive general anesthetics longer than 3 hours in total. |
| |
| Short-time anesthesia exposure | Infants receive general anesthetics shorter than 3 hours in total. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| General Anesthetics | Drug | General anesthesia required for surgery procedures or diagnostic interventions using either intravenous or inhalation anesthetics, or both. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of the developmental quotient of the Gesell Developmental Inventory | The Gesell Developmental Inventory has been translated into Chinese and standardized by the Beijing Children's Health Care Institute and the performance results are expressed as a developmental quotient (DQ). | From baseline before anesthesia to 1 year after anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| Change of the standardized score of the five domains of the Gesell Developmental Inventory | The five behavioral domains are gross motor, fine motor, language, adaptive, and personal-social behaviors. | From baseline before anesthesia to 1 year after anesthesia |
| Change of the standardized score of the Social Maturity Scale |
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Inclusion Criteria:
Exclusion Criteria:
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Eligible infants scheduled for elective surgeries under general anesthesia will be recruited in six medical centers in Shanghai, China. The medical centers include Huashan Hospital Fudan University, Shanghai Children's Medical Center, Children's Hospital of Fudan University, Children's Hospital of Shanghai, Shanghai Tenth People's Hospital, and Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiao-Yu Yang, M.D. | Contact | 52889999 | 7693 | yangxiaoyu@huashan.org.cn |
| Meng-Qiang Luo, M.D. | Contact | 52889999 | 7693 | viteroman@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Ying-Wei Wang, M.D., Ph.D. | Huashan Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200040 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 28915132 |
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| ID | Term |
|---|---|
| D018681 | Anesthetics, General |
| D000768 | Anesthesia, General |
| ID | Term |
|---|---|
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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| OTHER |
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
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|
The Social Maturity Scale includes six domains and 132 questions designed to be completed by the parents. |
| From baseline before anesthesia to 1 year after anesthesia |
| Background |
| Graham MR. Clinical update regarding general anesthesia-associated neurotoxicity in infants and children. Curr Opin Anaesthesiol. 2017 Dec;30(6):682-687. doi: 10.1097/ACO.0000000000000520. |
| 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. |
| 29672337 | Background | Warner DO, Zaccariello MJ, Katusic SK, Schroeder DR, Hanson AC, Schulte PJ, Buenvenida SL, Gleich SJ, Wilder RT, Sprung J, Hu D, Voigt RG, Paule MG, Chelonis JJ, Flick RP. Neuropsychological and Behavioral Outcomes after Exposure of Young Children to Procedures Requiring General Anesthesia: The Mayo Anesthesia Safety in Kids (MASK) Study. Anesthesiology. 2018 Jul;129(1):89-105. doi: 10.1097/ALN.0000000000002232. |
| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |