ClinicalTrials.Veeva

Menu

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

Seoul National University logo

Seoul National University

Status

Completed

Conditions

Strabismus

Treatments

Device: BIS

Study type

Observational

Funder types

Other

Identifiers

NCT02521259
B-1503-289-004

Details and patient eligibility

About

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.

Full description

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.

Enrollment

68 patients

Sex

All

Ages

3 to 5 years old

Volunteers

No Healthy Volunteers

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

Trial design

68 participants in 2 patient groups

low Bispectral index (BIS) group
Description:
BIS range under 40
Treatment:
Device: BIS
normal BIS group
Description:
BIS range from 40 to 60
Treatment:
Device: BIS

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems