Neurodevelopment of Infants Exposed to General Anesthesia: a Multi-center Investigation

NCT03629093 | Unknown DMC

• 1 other identifier: GENIUS
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

General Anesthetics Toxicity; Neurodevelopment; Infant

Keywords

General anesthesia; Infant; Neurodevelopment; Postoperative; the Gesell Developmental Inventory

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Change of the standardized score of the five domains of the Gesell Developmental Inventory

  From baseline before anesthesia to 1 year after anesthesia

• Change of the standardized score of the Social Maturity Scale

  From baseline before anesthesia to 1 year after anesthesia

Study Arms (2)

Long-time anesthesia exposure

Infants receive general anesthetics longer than 3 hours in total.

Drug: General Anesthetics

Short-time anesthesia exposure

Infants receive general anesthetics shorter than 3 hours in total.

Drug: General Anesthetics

Interventions

General Anesthetics DRUG

General anesthesia required for surgery procedures or diagnostic interventions using either intravenous or inhalation anesthetics, or both.

Also known as: General anesthesia

Long-time anesthesia exposure; Short-time anesthesia exposure

Eligibility Criteria

• Age: 4 Weeks - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• Apgar score ≥ 8 at birth
• ASA level Ⅰ\~Ⅲ
• Obtained written consent form from the infants' parents or guardians

You may not qualify if:

• Postmenstrual age ≤ 44 weeks, or postmenstrual age ≥ 144 weeks
• Severe cardiac, pulmonary, or neurologic disease
• Severe obstructive sleep apnea hypopnea syndrome
• History of dystocia and/or hypoxic ischemic encephalopathy
• Gestational age at birth ≤32 weeks
• Any known or suspected chromosomal abnormalities, abnormal development of vision or hearing, neurodevelopment retardation, or other known acquired or congenital abnormalities that might affect neurodevelopment
• Significant cardiovascular surgery, significant ENT surgery, or neurosurgery
• Malignant diseases that may reduce survival
• Taking part in other clinical trials in the last 3 months or at present

Sponsors & Collaborators

• Huashan Hospital: lead
• Shanghai Children's Medical Center: collaborator
• Children's Hospital of Fudan University: collaborator
• Shanghai Children's Hospital: collaborator
• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: collaborator
• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (1)

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Related Publications (4)

• 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: 26507180 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.

  PMID: 28915132 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.

  PMID: 27272582 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.

  PMID: 29672337 BACKGROUND

MeSH Terms

Interventions

Anesthetics, General; Anesthesia, General

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Anesthesia; Anesthesia and Analgesia

Study Officials

• Ying-Wei Wang, M.D., Ph.D.

  Huashan Hospital

  STUDY DIRECTOR

Central Study Contacts

Xiao-Yu Yang, M.D.

CONTACT

52889999; yangxiaoyu@huashan.org.cn

Meng-Qiang Luo, M.D.

CONTACT

52889999; viteroman@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: August 14, 2018
• Study Start: January 1, 2021
• Primary Completion: September 30, 2024
• Study Completion: December 30, 2024
• Last Updated: February 25, 2021

Record last verified: 2021-02

Locations

CN (1)