Postoperative Cognitive Dysfunction Clinical Trial
Official title:
Effects of General Anesthesia on Brain Functional Connectivity and Cognition in Children With Potential Neurological Damage
Postoperative Cognitive Dysfunction(POCD)is a common postoperative complications, existing clinical research focused on the adult patients, ignoring that the developing human brain with underlying neurological impairments may be at higher risk for cognitive impairment, so we need a prospective study, observe this kind of "special groups" in the brain structure and function of before and after general anesthesia, To determine the susceptibility to neurotoxicity of general anesthesia drugs.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | February 15, 2023 |
Est. primary completion date | January 1, 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | 4 Years to 10 Years |
Eligibility | Inclusion Criteria: 1. Age 4 to 10 years old, both sexes; 2. Apgar score =8 at birth; 3. ASA (American Society of Anesthesiologists Physical Condition Rating) ?-?; 4. to be treated with SDB under general anesthesia; 5. His legal guardian has signed the informed consent - Exclusion Criteria: 1. Age < 4 years old; or age >10 years old; 2. suffering from serious heart, lung and brain diseases; 3. History of dystocia or perinatal cerebral ischemia and hypoxia; 4. Gestational age at birth =32 weeks; 5. Confirmed or suspected neurological retardation or hearing and vision abnormalities; 6. suffering from malignant tumor; 7. had received general anesthesia or deep sedation before enrollment |
Country | Name | City | State |
---|---|---|---|
China | Department of Anesthesia, Shanghai Xinhua hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
China,
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* Note: There are 32 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in the scores of Wechsler intelligence scale | The scores of Wechsler intelligence scale before operation and 1 day after operation were compared between the two groups. | The 1 day before surgery;24 hours after surgery | |
Primary | The incidence of POCD | The incidence of POCD was calculated by Z-score method | up to 24 hours after surgery | |
Secondary | comparison of functional connectivity | The changes of brain functional connectivity were compared between the two groups under two states of consciousness (awake and anesthesia) | up to 5 minutes | |
Secondary | Correlation between fNIRS brain function connectivity and cognitive function changes | The correlation between cognitive function changes and brain functional connectivity, age and anesthesia time were evaluated | one day before surgery and 24 hours after surgery |
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