Clinical trial NCT06092671: Effect of FPCA on Incidence of Emergency Delirium in Children After Surgery
Official title: Effect of Family-centred Perioperative Care for Anaesthesia on Incidence of Emergency Delirium in Children After Surgery: a Protocol for a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Complications
Child
Family
Emergence Delirium
General Anaesthesia
Perioperative Care
Keywords: perioperative care
emergency delirium
paediatric
general anaesthesia
postoperative maladaptive behaviours
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 444
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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.

Primary outcomes:
measure: The incidence of emergency delirium
timeFrame: At the time patient awake from anesthesia after the sugery; 5min after awake; 15min after awake; 25min after awake;
Secondary outcomes:
measure: The severity of emergency delirium
timeFrame: At the time patient awake from anesthesia after the sugery; 5min after awake; 15min after awake; 25min after awake;
measure: The incidence of postoperative maladaptive behaviours
timeFrame: at postoperative days 1, 2, 3, 7±2, 14±3 days and 3 months ±5 days after surgery
measure: Cognitive function
timeFrame: Baseline before surgery and at 7±2 days and 3 months ±5 days after surgery
measure: Sleep quality
timeFrame: Baseline before surgery; at 7±2, 14±3 days and 3 months ±5 days after surgery
measure: Sleep quality data
timeFrame: the day before surgery to the night before discharge
measure: Quality of life
timeFrame: Baseline before the surgery and at 14±3 days and 3 months ±5 days after surgery.
measure: Compliance of anaesthesia induction
timeFrame: The period anaesthesia induction.
measure: Postoperative pain score
timeFrame: At the time patient awake from anesthesia after the sugery; 5min after awake; 15min after awake; 25min after awake.
measure: Preoperative anxiety of children
timeFrame: Baseline before surgery, in the preoperative holding area and during induction of anaesthesia.
measure: Preoperative anxiety of parents
timeFrame: Baseline before surgery, in the preoperative holding area and during induction of anaesthesia.
Other outcomes:
measure: Temperament of children
timeFrame: Within 2 weeks before the surgery
measure: Temperament of parents
timeFrame: Within 2 weeks before the surgery
Locations:
city: Wenzhou
country: China
facility: The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Department of Anaesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China
name: Ting Li, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References: