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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 29, 2025 (before its estimated September 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Secondary endpoints: 10 to 8
    • Collaborators expanded, about 17 words
    v5
  2. Primary completion date: Sep 2025 to Sep 2026
    • Study completion date: Dec 2025 to Dec 2026
    v4
  3. Enrollment target: 340 to 444v3 Show 6 more changesShow less
    • Primary completion date: Sep 2026 to Sep 2025
    • Study completion date: Dec 2026 to Dec 2025
    • Interventions: family-focused anesthesia strategies (Other) to Family-centred perioperative care for anaesthesia (Other)
    • Eligibility criteria shortened, about 11 words
    • Site contact updated
    • Study title shortened, about 9 words
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 2023 to Oct 24, 2023
    • Secondary endpoints: 8 to 10
    • Site details revised
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06092671
Lead Sponsor Second Affiliated Hospital of Wenzhou Medical University
Collaborators: Jinhua Municipal Central Hospital, Lishui Country People's Hospital, Ningbo No.2 Hospital, The Central Hospital of Lishui City
Conditions
(from sponsor)		 Postoperative Complications, Child, Family, Emergence Delirium, General Anaesthesia, Perioperative Care
Related terms Emergence Delirium, Postoperative Complications
Enrollment 444 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov