NCT06092671 Effect of FPCA on Incidence of Emergency Delirium in Children After Surgery
| NCT ID | NCT06092671 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Affiliated Hospital of Wenzhou Medical University |
| Condition | Postoperative Complications |
| Study Type | INTERVENTIONAL |
| Enrollment | 444 participants |
| Start Date | 2023-10-24 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 444 participants in total. It began in 2023-10-24 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion criteria: 1. Children aged 2-6 years undergoing elective surgery with an estimated surgical duration of no longer than 2 hours; 2. Receiving first general anaesthesia by inhalation, and American Society of Anaesthesiology (ASA) physical status I to II; 3. A parent signed the informed consent form. Exclusion criteria: 1. Suffering important organ diseases; 2. History of developmental retardation, neuropsychiatric diseases, psychological or cognitive impairment; 3. History of severe hearing or visual impairment; 4. Children are not suitable for inhalation anaesthesia considered by the researchers; 5. The parent involving in this trial spends less than three months a year with the child; 6. The parent is not competent for companionship considered by the researchers; 7. Neither father nor mother is able to participate in the screening interview and the trial.
Contact & Investigator
Ting Li, MD. PhD
PRINCIPAL INVESTIGATOR
Department of Anaesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China
Frequently Asked Questions
Who can join the NCT06092671 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 6 Years, studying Postoperative Complications. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06092671 currently recruiting?
Yes, NCT06092671 is actively recruiting participants. Contact the research team at liting1021@aliyun.com for enrollment information.
Where is the NCT06092671 trial being conducted?
This trial is being conducted at Wenzhou, China.
Who is sponsoring the NCT06092671 clinical trial?
NCT06092671 is sponsored by Second Affiliated Hospital of Wenzhou Medical University. The principal investigator is Ting Li, MD. PhD at Department of Anaesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China. The trial plans to enroll 444 participants.