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

Fudan University

Status

Enrolling

Conditions

Infant

General Anesthetics Toxicity

Neurodevelopment

Treatments

Drug: General Anesthetics

Study type

Observational

Funder types

Other

Identifiers

NCT03629093

GENIUS

Details and patient eligibility

About

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.

Enrollment

1,000 estimated patients

Sex

All

Ages

4 weeks to 2 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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