Status:
RECRUITING
Effect of FPCA on Incidence of Emergency Delirium in Children After Surgery
Lead Sponsor:
Second Affiliated Hospital of Wenzhou Medical University
Collaborating Sponsors:
Jinhua Municipal Central Hospital
Lishui Country People's Hospital
Conditions:
Postoperative Complications
Child
Eligibility:
All Genders
2-6 years
Phase:
NA
Brief Summary
Emergence delirium (ED) stands out as a prevalent postoperative complication among paediatric patients, correlating with extended hospitalization periods, escalated healthcare expenses, and increased ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Children aged 2-6 years undergoing elective surgery with an estimated surgical duration of no longer than 2 hours;
- Receiving first general anaesthesia by inhalation, and American Society of Anaesthesiology (ASA) physical status I to II;
- A parent signed the informed consent form.
- Exclusion criteria:
- Suffering important organ diseases;
- History of developmental retardation, neuropsychiatric diseases, psychological or cognitive impairment;
- History of severe hearing or visual impairment;
- Children are not suitable for inhalation anaesthesia considered by the researchers;
- The parent involving in this trial spends less than three months a year with the child;
- The parent is not competent for companionship considered by the researchers;
- Neither father nor mother is able to participate in the screening interview and the trial.
Exclusion
Key Trial Info
Start Date :
October 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
444 Patients enrolled
Trial Details
Trial ID
NCT06092671
Start Date
October 24 2023
End Date
December 1 2026
Last Update
December 29 2025
Active Locations (1)
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1
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China