Effect of FPCA on Incidence of Emergency Delirium in Children After Surgery
Recruiting now · Not applicable
Conditions studied: Postoperative Complications, Child, Family, Emergence Delirium, General Anaesthesia, Perioperative Care
In brief
Emergence delirium (ED) stands out as a prevalent postoperative complication among paediatric patients, correlating with extended hospitalization periods, escalated healthcare expenses, and increased incidence of postoperative maladaptive behaviours (POMBs). There is a lack of well-established pharmacological or non-pharmacological interventions demonstrating efficacy in reducing the occurrence of ED. Therefore, our objective is to assess the potential of family-centred perioperative care for anaesthesia (FPCA) in mitigating the incidence of ED in children, compared with routine anaesthesia.
Key facts
- Study ID
- NCT06092671
- Run by
- Second Affiliated Hospital of Wenzhou Medical University
- People needed
- 444
- Starts
- 2023-10-24
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2025-12-29
Who can join
Age: 2 and older, up to 6. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (enrolling)
Full record on ClinicalTrials.gov
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