Anesthetic Depth and the Incidence of Emergence Agitation in Children Undergoing Strabismus Surgery

This study evaluates the association between the depth of general anesthesia and the occurrence of emergence agitation (EA). The investigators hypothesized that optimal level of anesthetic depth could decrease the incidence of EA in children undergoing strabismus surgery compared to the deep level of anesthetic depth.

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Key information

Conditions

Strabismus Confusion Cranial Nerve Diseases Delirium Emergence Delirium Eye Diseases Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Ocular Motility Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Bundang Hospital, department of Anesthesia and pain

Seongnam, Gyenggo-do, 13620, South Korea

About this study

EA is characterized by dissociated state of consciousness, in which the children are inconsolable, irritable, uncooperative, thrashing, crying, moaning or incoherent.

Several predisposing factors for EA include post-operative pain, rapid emergence from general anesthesia, use of volatile anesthetics, type and site of operation (usually head & neck surgeries), agitation on induction, airway obstruction, hyperthermia or hypothermia.

The effect of anesthetic depth on the EA has rarely been evaluated in pediatric population, even though postoperative delirium or postoperative cognitive dysfunction (POCD)corresponds to the EA identically.

In this study, the concentration of anesthetics was not managed on purpose to lower the BIS score. Patients were allocated to each group based on the result of average BIS score during the operation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

aged between 3 and 5 years
American Society of Anesthesiologists physical status I or II

Exclusion criteria

American Society of Anesthesiologists physical status over III,
any disease that could affect mental status
pre-existing forehead wound

Treatment and study plan

BIS

Device

BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient.

Primary outcomes

the Pediatric Anesthesia Emergence Delirium (PAED) Score

Time frame: 30 minutes

Evaluating the Pediatric Anesthesia Emergence Delirium (PAED) score 3 times at the post-anesthetic care unit (PACU): when participant arrived at PACU, measure the PAED score (from 0 to 20; the higher score indicates the severer emergenct agitation) immediately and if the score is 10 or over 10, give the participant Fentanyl 1mcg/kg. Repeat checking the PAED score 2 times more with 15 minutes interval.

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

The Correlation Between Anesthetic Depth and the Incidence of Emergence Agitation in Children Undergoing Strabismus Surgery

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Aug 13, 2015
Registry last updated: Oct 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed