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

Second Affiliated Hospital of Wenzhou Medical University

Status: Enrolling

Conditions: Postoperative Complications; Child; Perioperative Care; General Anaesthesia; Family; Emergence Delirium

Treatments: Other: Family-centred perioperative care for anaesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT06092671

SAHoWMU-CR2023-03-110

Details and patient eligibility

About

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.

Enrollment: 444 estimated patients

Sex: All

Ages: 2 to 6 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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444 participants in 2 patient groups

Family-Centered group (F group)

Experimental group

Description:

Both children and parents received family-centred perioperative care for anaesthesia including video education, anaesthesia mask practice, e-manual learning,etc. It is also recommended that a parent accompany the child during both anesthesia induction and recovery.

Treatment:

Other: Family-centred perioperative care for anaesthesia

Routine group (R group)

No Intervention group

Description:

The child received clinical standard preoperative education and anesthesia induction. The child was not accompanied by the parents during the anesthesia induction period and the awakening period.