Effect of FPCA on Incidence of Emergency Delirium in Children After Surgery

NCT06092671 | Recruiting DMC

• 1 other identifier: SAHoWMU-CR2023-03-110
• Study Type: interventional
• Target: 444
• Locations: 1 country
• Sites: 1

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.

Conditions

Family; Emergence Delirium; General Anaesthesia; Perioperative Care; Postoperative Complications; Child

Keywords

perioperative care; emergency delirium; paediatric; general anaesthesia; postoperative maladaptive behaviours

Outcome Measures

Primary Outcomes (1)

• The incidence of emergency delirium

  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).

  At the time patient awake from anesthesia after the sugery; 5min after awake; 15min after awake; 25min after awake;

Secondary Outcomes (8)

• The severity 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 postoperative maladaptive behaviours

  at postoperative days 1, 2, 3, 7±2, 14±3 days and 3 months ±5 days after surgery

• Sleep quality

  Baseline before surgery; at 7±2, 14±3 days and 3 months ±5 days after surgery

• Quality of life score

  Baseline before the surgery and at 14±3 days and 3 months ±5 days after surgery.

• Compliance of anaesthesia induction

  The period anaesthesia induction.

Study Arms (2)

Family-Centered group (F group)

EXPERIMENTAL

Both children and parents received family-centred perioperative care for anaesthesia including video education, anaesthesia mask practice, e-manual learning,etc. It is also recommended that a parent accompany the child during both anesthesia induction and recovery.

Other: Family-centred perioperative care for anaesthesia

Routine group (R group)

NO INTERVENTION

The child received clinical standard preoperative education and anesthesia induction. The child was not accompanied by the parents during the anesthesia induction period and the awakening period.

Interventions

Family-centred perioperative care for anaesthesia OTHER

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.

Family-Centered group (F group)

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• The Central Hospital of Lishui City: collaborator
• Second Affiliated Hospital of Wenzhou Medical University: lead
• Jinhua Municipal Central Hospital: collaborator
• Lishui Country People's Hospital: collaborator
• Ningbo No.2 Hospital: collaborator

Study Sites (1)

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

RECRUITING

Related Publications (1)

• Chen J, Hu J, Zheng C, Song S, Yang C, Ye F, Li T. Effect of family-centred perioperative care for anaesthesia on the incidence of emergence delirium in children after surgery: a protocol for a randomised controlled trial in China. BMJ Open. 2025 Jul 6;15(7):e089863. doi: 10.1136/bmjopen-2024-089863.

  PMID: 40623754 DERIVED

MeSH Terms

Conditions

Postoperative Complications; Emergence Delirium

Interventions

Anesthesia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

• Ting Li, MD. PhD

  Department of Anaesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ting Li, MD. PhD

CONTACT

+86-135-8787-6896; liting1021@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 24, 2023
• First Posted: October 23, 2023
• Study Start: October 24, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months after publication with no end date
• Access Criteria: De-identified participant data underlying the findings will be made available upon reasonable request. Proposals for data access should be directed to the corresponding author (liting1021@aliyun.com).

Locations

CN (1)