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To explore the relationship between the changes of intraoperative EEG characteristics mediated by different sedatives and postoperative adverse behavior changes in children undergoing strabismus surgery

To explore the relationship between the changes of intraoperative EEG characteristics mediated by different sedatives and postoperative adverse behavior changes in children undergoing strabismus surgery

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086490
Enrollment
Unknown
Registered
2024-07-02
Start date
2024-07-15
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

Pediatric strabismus surgery and anesthesia

Interventions

Midazolam group:3min before anesthesia induction, midazolam group was given 0.1mg/kg intravenous slow injection
Dexmedetomidine group:3min before anesthesia induction, dexmedetomidine group was given 1ug/kg intravenous slow injection

Sponsors

Xuzhou First People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 7 Years

Inclusion criteria

Inclusion criteria: (1) ASA is grade I ~ II; (2) Age 2-7 years old; (3) Elective strabismus surgery was proposed.

Exclusion criteria

Exclusion criteria: (1) Severe comorbidities of ASA grade III and above; (2) Allergic to dexmedetomidine or midazolam; (3) Use of preoperative sedatives on the day of surgery; (4) The operation time is less than 10 minutes or more than 60 minutes; (5) Existing behavioral problems (treated by a pediatrician for behavioral problems or currently on medication for behavioral problems such as attention deficit, hyperactivity disorder, etc.); (6) Have mental health problems (autism, anxiety, etc.) or take psychiatric drugs before surgery; (7) Family members or guardians refuse to participate.

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative 3d adverse behavior change;

Secondary

MeasureTime frame
Wake delirium score (PAED score);Incidence of adverse behavior changes at 1d, 7d and 28d after surgery;EEG characteristics of children during operation and after recovery;Postoperative Pain Score (FLACC Score);Incidence of other adverse events (allergies, nausea, vomiting, chills);Recovery time and postoperative hospital stay;Parental satisfaction;

Countries

China

Contacts

Public ContactBizhao Dai

Xuzhou First People's Hospital of Jiangsu Province

13952236240@163.com+86 139 5223 6240

Outcome results

None listed

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