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Study on the correlation between sevoflurane general anesthesia exposure and adverse cognitive and behavioral outcomes in preschool children and exploration of potential blood risk markers

Study on the correlation between sevoflurane general anesthesia exposure and adverse cognitive and behavioral outcomes in preschool children and exploration of potential blood risk markers

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400090174
Enrollment
Unknown
Registered
2024-09-25
Start date
2024-10-01
Completion date
Unknown
Last updated
2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General anesthesia with sevoflurane

Interventions

Sevoflurane general anesthesia exposure group:No intervention
Control group (healthy kindergarten children):No intervention

Sponsors

Department of Anesthesiology, Cancer Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 6 Years

Inclusion criteria

Inclusion criteria: 1. Exposure group: ? Age: 4~6 years old ? ASA classification: grade I~II ? Undergoing sevoflurane general anesthesia ? Surgery involving relatively little tissue dissection, and the children do not require long-term follow-up; 2. Control group: ? Age: 4~6 years old ? ASA grading: Grade I ? Children who have never been exposed to general anesthetic sedation or surgery.

Exclusion criteria

Exclusion criteria: ? high-risk preterm infants: the presence of gestational age <34 weeks, or birth weight <2000g, early serious comorbidities or complications, early feeding difficulties, slow weight gain, and any other abnormalities; ? obesity (according to the 2007 WHO recommended growth and development standards, that is, children of different genders and ages of children with a BMI above the 95th percentile of the recommended definition of obesity, excluding pathological and secondary obesity) Obesity (according to the 2007 WHO recommended growth and development standards, i.e., children of different genders and ages are defined as obese if their BMI is higher than the 95th percentile, excluding pathological and secondary obesity); ? the existence of genetic or chromosomal diseases; ? the existence of diseases of the central nervous system, congenital disorders, or visual and auditory disorders; ? the intention to undergo neurosurgery, cardiothoracic surgery or undergoing surgery; ? the existence of a confirmed diagnosis of developmental delays, intellectual disabilities, mental disorders or a relevant positive family history; ? the lack of cooperation of the child or family members; and ? the failure to assess the results of any scale.

Design outcomes

Primary

MeasureTime frame
CBCL/4 to 16 Total Crude Score for Behavioural Problems 6 months after enrolment;;

Secondary

MeasureTime frame
CBCL/4~16 crude scores for each factor 6 months after enrolment;;Incidence of abnormalities in each factor of CBCL/4~16 after 6 months of enrolment;;BRIEF-P scores on five factors (inhibit/shift/emotional control/working memory/plan /organise) as well as three dimensions (ISCI/FI/EMI) after 6 months of enrolment;;Total score of the 50-item pre-school intelligence screening scale after 6 months of enrolment.;Preoperative CBCL/4~16 and BRIEF-P baseline scores of subjects in both groups;;Pre- and postoperative serum H2S, CBS, and 3-MST in exposed groups.;50-item pre-school intelligence screening scale scores in each ability area ( self-awareness, motor skills, memory skills, observation skills, thinking skills, general knowledge ) 6 months after enrolment;

Countries

China

Contacts

Public ContactChai Jun

Department of Anesthesiology, Shengjing Hospital of China Medical University

chaijun_cmu@163.com+86 189 4025 9928

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026