Effect of FPCA on Incidence of Emergency Delirium in Children After Surgery
NCT ID: NCT06092671
Last Updated: 2024-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
444 participants
INTERVENTIONAL
2023-10-24
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Family-Centered group (F group)
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.
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, distraction strategies and parental presence. The patient will not receive sedatives before surgery. During the anesthesia induction period, it is recommended that the parent be instructed by the anesthesiologist to complete the induction of inhalation of the anesthesia mask, and the patient will be accompanied by the parent during the awakening period.
Routine group (R group)
The child received clinical standard preoperative education and anesthesia induction. It is recommended to give sedatives (such as oral midazolam or dexmedetomidine nasal drops, etc.) before surgery. The child was not accompanied by the parents during the anesthesia induction period and the awakening period.
No interventions assigned to this group
Interventions
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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, distraction strategies and parental presence. The patient will not receive sedatives before surgery. During the anesthesia induction period, it is recommended that the parent be instructed by the anesthesiologist to complete the induction of inhalation of the anesthesia mask, and the patient will be accompanied by the parent during the awakening period.
Eligibility Criteria
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Inclusion Criteria
2. Receiving first general anaesthesia by inhalation, and American Society of Anaesthesiology (ASA) physical status I to II;
3. A parent signed the informed consent form.
Exclusion Criteria
2. History of developmental retardation, neuropsychiatric diseases, psychological or cognitive impairment;
3. History of severe hearing or visual impairment;
4. Children are not suitable for inhalation anaesthesia considered by the researchers;
5. The parent involving in this trial spends less than three months a year with the child;
6. The parent is not competent for companionship considered by the researchers;
7. Neither father nor mother is able to participate in the screening interview and the trial.
2 Years
6 Years
ALL
No
Sponsors
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Second Affiliated Hospital of Wenzhou Medical University
OTHER
Responsible Party
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TING LI
Principal Investigator
Principal Investigators
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Ting Li, MD. PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Anaesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China
Locations
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The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Ting Li, MD. PhD
Role: primary
References
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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.
Other Identifiers
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SAHoWMU-CR2023-03-110
Identifier Type: -
Identifier Source: org_study_id