Second Affiliated Hospital of Wenzhou Medical University
Phase
Not applicable
Started
2023-10-24
Last updated
2025-12-29
Condition(s) studied
Postoperative ComplicationsChildFamilyEmergence DeliriumGeneral AnaesthesiaPerioperative Care
Investigational drug(s) / intervention(s)
Family-centred perioperative care for anaesthesia
Family-centred perioperative care for anaesthesia: The patient in intervention group and parent will receive the Family-centred perioperative care for anaesthesia, including video education, anaesthesia mask practice, electronic pamphlet,etc. It is recommended that parents accompany the children during the induction of anesthesia and the recovery from anesthesia.
Study 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
Sex
ALL
Min age
2 Years
Max age
6 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
The incidence of emergency delirium — At the time patient awake from anesthesia after the sugery; 5min after awake; 15min after awake; 25min after awake; The incidence of emergency delirium will be evaluated by the Pediatric Anesthesia Emergency Delirium scale (PAED). When the child wakes up in the PACU (the child can stay awake for more than 10 seconds), and 5min, 15min, 25min after waking up, a trained researcher will evaluate the PAED score (the maximum scores ≥10 will be diagnosed as ED).
Trial sites (1)
Facility
City
Region
Status
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou
Zhejiang
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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