The Effect of Anesthesia Depth Monitoring on Emergence Delirium in Pediatrics

NCT06323616 | Completed

• 1 other identifier: 2023/2343
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia; Emergence Delirium; Anesthesia Awareness; Behavior Child Problems; Postoperative Delirium; Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• ED/EA incidence

  The Pediatric Anesthesia Recovery Delirium (PAED) Scale Score will be used. This score consists of 5 criteria (maximum score 20) scored using 0-4 point scales. These criteria; The child must make eye contact with the caregiver, the child's movements are purposeful, the child is aware of the surroundings, the child is restless/irritable, and the child cannot be consoled. A score of ≥10 will be considered EA, and a score of \>12 will be considered ED.

  postoperative 5th, 15th and 30th minutes

Secondary Outcomes (21)

• mYPAS

  immediately before induction of anesthesia

• PSI <25 episode duration

  intraoperative

• PSI >50 episode duration

  intraoperative

• PSI <25 number of episodes

  intraoperative

• PSI >50 number of episodes

  intraoperative

Study Arms (2)

Control Group

NO INTERVENTION

Sevoflurane anesthesia will be applied with an endtidal agent consumption of 0.8 MACage, with 2 standard deviations for MACage:1 to the control group, as we apply in routine anesthesia practice. (During the surgery, the parameters showing the depth of anesthesia will be placed away from the anesthesiologist and covered to ensure blindness. At the end of the surgery, the data will be received via USB.)

Study Group

EXPERIMENTAL

Sevoflurane anesthesia will be applied to the study group by adjusting the MAC to keep the PSI median value between 25-50 (if PSI\<25, MAC will be reduced by 0.1, if PSI\>50, MAC will be increased by 0.1).

Procedure: MAC adjustment to PSI between 25 and 50

Interventions

MAC adjustment to PSI between 25 and 50 PROCEDURE

According to SedLine monitoring, the depth of anesthesia will be adjusted by changing the amount of sevoflurane so that the PSI median value is between 25 and 50.

Study Group

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• to 8 years old
• Surgery time \> 1 hour
• Urology, Plastic Surgery and Pediatric Surgery patients

You may not qualify if:

• Patients with neuromotor development abnormalities
• Patients with a history of epilepsy/antiepileptic treatment
• Patients receiving intraoperative ketamine administration
• Patients requiring postoperative ICU admission
• Surgeries performed under emergency conditions
• Patients without parental consent

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

• Murray HW, Soave R. Appendicitis with perforation: a reminder to internists. South Med J. 1980 Jun;73(6):730-1. doi: 10.1097/00007611-198006000-00013.

  PMID: 7394591 BACKGROUND

• Ricci Z, Robino C, Rufini P, Cumbo S, Cavallini S, Gobbi L, Brocchi A, Serio P, Romagnoli S. Monitoring anesthesia depth with patient state index during pediatric surgery. Paediatr Anaesth. 2023 Oct;33(10):855-861. doi: 10.1111/pan.14711. Epub 2023 Jun 19.

  PMID: 37334678 BACKGROUND

• Kain ZN, Caldwell-Andrews AA, Maranets I, McClain B, Gaal D, Mayes LC, Feng R, Zhang H. Preoperative anxiety and emergence delirium and postoperative maladaptive behaviors. Anesth Analg. 2004 Dec;99(6):1648-1654. doi: 10.1213/01.ANE.0000136471.36680.97.

  PMID: 15562048 BACKGROUND

MeSH Terms

Conditions

Emergence Delirium; Intraoperative Awareness; Postoperative Complications

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Intraoperative Complications

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized, Single-Blind, Prospective, Interventional

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: March 21, 2024
• Study Start: February 22, 2024
• Primary Completion: February 27, 2025
• Study Completion: March 31, 2025
• Last Updated: April 8, 2025

Record last verified: 2024-07

Locations

TU (1)