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Идёт набор NCT06092671

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

Без фазы С лечением Postoperative Complications Child Family Emergence Delirium

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Family-centred perioperative care for anaesthesia.
Кому может быть актуально
Состояния в реестре: Postoperative Complications, Child, Family, Emergence Delirium. Базовые параметры: 2 лет — 6 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

  • Другое 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.

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

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

Публикации

  • 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

Идентификаторы

NCT: NCT06092671 · SAHoWMU-CR2023-03-110

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗