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Recruiting NCT06092671

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

No phase Interventional Postoperative Complications Child Family Emergence Delirium

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Family-centred perioperative care for anaesthesia.
Who it may be relevant to
Registry conditions: Postoperative Complications, Child, Family, Emergence Delirium. Basic parameters: 2 years — 6 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effect of Family-centred Perioperative Care for Anaesthesia on Incidence of Emergency Delirium in Children After Surgery: a Protocol for a Randomised Controlled Trial

Overview

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.

Interventions

  • Other 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.

Primary outcome measures

  • The incidence of emergency delirium [Time frame: At the time patient awake from anesthesia after the sugery; 5min after awake; 15min after awake; 25min after awake;]
Secondary outcome measures (8)
  • The severity of emergency delirium [Time frame: 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 [Time frame: at postoperative days 1, 2, 3, 7±2, 14±3 days and 3 months ±5 days after surgery]
  • Sleep quality [Time frame: Baseline before surgery; at 7±2, 14±3 days and 3 months ±5 days after surgery]
  • Quality of life score [Time frame: Baseline before the surgery and at 14±3 days and 3 months ±5 days after surgery.]
  • Compliance of anaesthesia induction [Time frame: The period anaesthesia induction.]
  • Postoperative pain score [Time frame: At the time patient awake from anesthesia after the sugery; 5min after awake; 15min after awake; 25min after awake.]
  • Preoperative anxiety of children [Time frame: Baseline before surgery, in the preoperative holding area and during induction of anaesthesia.]
  • Preoperative anxiety of parents [Time frame: Baseline before surgery, in the preoperative holding area and during induction of anaesthesia.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

China · 1 center
  • The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical Universit — Wenzhou

Publications

  • 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

Identifiers

NCT: NCT06092671 · SAHoWMU-CR2023-03-110

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗