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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2024-12-30

Brief Summary

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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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Detailed Description

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Conditions

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General Anesthetics Toxicity Neurodevelopment Infant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Long-time anesthesia exposure

Infants receive general anesthetics longer than 3 hours in total.

General Anesthetics

Intervention Type DRUG

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

Short-time anesthesia exposure

Infants receive general anesthetics shorter than 3 hours in total.

General Anesthetics

Intervention Type DRUG

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

Interventions

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General Anesthetics

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

Intervention Type DRUG

Other Intervention Names

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General anesthesia

Eligibility Criteria

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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

Minimum Eligible Age

4 Weeks

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No