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

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

Interventions

DRUG

General Anesthetics

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

Sponsors & Collaborators

• Shanghai Children's Medical Center

  collaborator OTHER

• Children's Hospital of Fudan University

  collaborator OTHER

• Shanghai Children's Hospital

  collaborator OTHER

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

  collaborator OTHER

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  collaborator OTHER

• Huashan Hospital

  lead OTHER

Principal Investigators

• Ying-Wei Wang, M.D., Ph.D. · Huashan Hospital

Eligibility

Min Age

4 Weeks

Max Age

2 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-01

Primary Completion

2024-09-30

Completion

2024-12-30

Countries

• China

Study Locations