Effect of FPCA on Incidence of Emergency Delirium in Children After Surgery
Launched by SECOND AFFILIATED HOSPITAL OF WENZHOU MEDICAL UNIVERSITY · Oct 15, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new approach called Family-centered Perioperative Care for Anesthesia (FPCA), which aims to see if it can help reduce emergency delirium (ED) and other difficult behaviors in children after surgery. Emergency delirium can cause confusion and distress in kids after they wake up from anesthesia, leading to longer hospital stays and increased healthcare costs. The researchers want to find out if involving family more actively during the surgery process can help improve outcomes compared to traditional methods.
The trial is looking for children aged 2 to 6 years who are scheduled for elective surgery lasting no more than 2 hours and who will be using inhalation anesthesia for the first time. To participate, children should not have any major health issues or developmental delays, and at least one parent must be available and willing to help with the study. If your child qualifies and you choose to participate, you can expect to engage in a supportive environment that emphasizes family involvement during the surgical experience. This study is currently in the recruiting phase, so families interested in participating can learn more about the process and how it may benefit their child.
Gender
ALL
Eligibility criteria
- Inclusion criteria:
- • 1. Children aged 2-6 years undergoing elective surgery with an estimated surgical duration of no longer than 2 hours;
- • 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:
- • 1. Suffering important organ diseases;
- • 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.
About Second Affiliated Hospital Of Wenzhou Medical University
The Second Affiliated Hospital of Wenzhou Medical University is a leading clinical research institution in China, renowned for its commitment to advancing medical knowledge and improving patient care. As a prominent teaching hospital, it integrates clinical practice with innovative research and education, fostering a collaborative environment for healthcare professionals. The hospital is equipped with state-of-the-art facilities and a diverse range of specialized departments, enabling it to conduct comprehensive clinical trials across various medical fields. Its mission is to enhance healthcare outcomes through rigorous scientific inquiry and to contribute to the global body of medical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Wenzhou, Zhejiang, China
Patients applied
Trial Officials
Ting Li, MD. PhD
Principal Investigator
Department of Anaesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported