NCT06323616

The Effect of Anesthesia Depth Monitoring on Emergence Delirium in Pediatrics

Completed NA Last updated 8 April 2025

What this trial tests

NA trial testing MAC adjustment to PSI between 25 and 50 in Anesthesia in 250 participants. Completed in 31 March 2025.

Timeline

22 February 2024

Primary endpoint
27 February 2025

31 March 2025

Quick facts

Lead sponsor	Istanbul University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	screening
Enrollment	250
Start date	22 February 2024
Primary completion	27 February 2025
Estimated completion	31 March 2025
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• MAC adjustment to PSI between 25 and 50

Conditions studied

• Anesthesia — all drugs for Anesthesia →
• Emergence Delirium — all drugs for Emergence Delirium →
• Anesthesia Awareness — all drugs for Anesthesia Awareness →
• Behavior Child Problems — all drugs for Behavior Child Problems →

Sponsor

Istanbul University

Who can join

Adults 2 to 8, any sex, with Anesthesia or Emergence Delirium. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Some changes in the patient's cognitive state are observed during the recovery period from general anesthesia. This period of behavioral dysregulation has been called emergence agitation (EA) and emergence delirium (ED). ED and EA occur in the early postoperative period (often within the first 30 minutes). The incidence of ED ranges from 10% to 80% in children and is described as a distressing clinical condition by 42% of pediatric anesthesiologists. Self-harm by the child increases the risk of delayed discharge and may increase the cost of medical care.

Sevoflurane is a widely used agent for the induction and maintenance of anesthesia, but its use is associated with the occurrence of ED in the pediatric population. Clinical findings are characterized by hallucinations, struggling, restlessness, crying, and disorientation.

In the literature, the Pediatric Anesthesia Rescue Delirium (PAED) Scale Score is used in the diagnosis of ED and EA. This score consists of 5 criteria (maximum score 20) scored using 0-4 point scales. These criteria; The child needs to make eye contact with the caregiver, the child's movements are purposeful, the child is aware of the environment, the child is restless/angry, the child cannot be consoled. While the sensitivity of ≥10 points for the diagnosis of ED is 64% and the specificity is 86%, the sensitivity of \>12 points for the diagnosis of ED is 100% and the specificity is 94.5%.

Monitoring intraoperative depth of anesthesia in the adult population has been recommended by the American Society of Anesthesiologists (ASA) due to its potential benefits such as faster recovery time and lower drug dosage, as well as prevention of adverse effects such as the incidence of hypotension. The use of anesthesia depth monitors used so far for children is controversial because brain development in children has not yet been completed and the calculation algorithms of these indices are based on adult EEG characteristics.

There are very few studies in the literature on the relationship between anesthesia depth monitoring and EA/ED in children, and further studies are needed.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.