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

Not Applicable

Recruiting

• Conditions: Postoperative Complications; Child; Family; Emergence Delirium; General Anaesthesia; Perioperative Care
• Interventions: Other: family-focused anesthesia strategies

• Registration Number: NCT06092671
• Lead Sponsor: Second Affiliated Hospital of Wenzhou Medical University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-24
• Study First Submitted QC: 2023-10-15
• Study First Posted: 2023-10-23
• Study Start: 2023-10-24
• Status Verified: 2024-09
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-19
• Primary Completion: 2025-09
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 444

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Family-Centered group (F group)	family-focused anesthesia strategies	Both children and parents received family-centred perioperative care for anaesthesia including video education, anaesthesia mask practice, e-manual learning,etc. And children will be accompanied by their parents during anaesthsia induction and recovery.

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
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 severity of emergency delirium was assessed according to PAED scores in those patients who suffered emergency delirium. A total score ≥12 is considered moderate emergency delirium, ≥15 is considered severe emergency delirium, and the total score of the scale is 20.
The incidence of postoperative maladaptive behaviours	at postoperative days 1, 2, 3, 7±2, 14±3 days and 3 months ±5 days after surgery	Postoperative maladaptive behavioural changes at the 1, 2, 3, 7±2, 14±3 days and 3 months±5 days after surgery will be assessed with Post Hospitalization Behaviour Questionnaire (PHBQ). When total score greater than 0 will be considered as postoperative maladaptive behaviours.
Cognitive function	Baseline before surgery and at 7±2 days and 3 months ±5 days after surgery	Cognitive function before surgery and at 7±2 days and 3 months ±5 days after surgery, assessed with the Wechsler Preschool and Primary Scale of Intelligence- Ⅳ(WPPSI-Ⅳ).
Sleep quality	Baseline before surgery; at 7±2, 14±3 days and 3 months ±5 days after surgery	Sleep quality before surgery and at 7±2, 14±3 days and 3 months ±5 days after surgery, assessed with Children's Sleep Habits Questionnaire (CSHQ).
Sleep quality data	the day before surgery to the night before discharge	Sleep quality data (total sleep time \[TST\], and sleep efficiency \[SE\]) from the day before surgery to the night before discharge recorded by Actigraphy.
Quality of life	Baseline before the surgery and at 14±3 days and 3 months ±5 days after surgery.	Quality of life will be assessed with Pediatric Quality of Life Inventory 4.0 (PedsQL4.0).
Compliance of anaesthesia induction	The period anaesthesia induction.	Compliance of anaesthesia induction in children will be assessed with Induction Compliance Checklist (ICC).
Postoperative pain score	At the time patient awake from anesthesia after the sugery; 5min after awake; 15min after awake; 25min after awake.	Postoperative pain score in children will be assessed with Face, Legs, Activity, Cry, Consolability scale (FLACC).
Preoperative anxiety of children	Baseline before surgery, in the preoperative holding area and during induction of anaesthesia.	Preoperative anxiety of children will be assessed with the modified Yale Preoperative Anxiety Scale-Short Form (mYPAS-SF).
Preoperative anxiety of parents	Baseline before surgery, in the preoperative holding area and during induction of anaesthesia.	Preoperative anxiety of parents will be assessed with State Trait Anxiety Inventory (STAI).

Trial Locations

Locations (1)

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China