Effect of Family-centred Perioperative Care for Anaesthesia on Incidence of Emergency Delirium in Children After Surgery: a Protocol for a Randomised Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 6
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Contact Information
Primary
Ting Li, MD. PhD
liting1021@aliyun.com
+86-135-8787-6896
Time Frame
Start Date:2023-10-24
Estimated Completion Date:2025-12
Participants
Target number of participants:444
Treatments
Experimental: 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.
No_intervention: 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.