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Clinical Trials/NCT02521259
NCT02521259
Completed
N/A

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

Seoul National University Bundang Hospital1 site in 1 country68 target enrollmentApril 2015
ConditionsStrabismus

Overview

Phase
N/A
Intervention
Not specified
Conditions
Strabismus
Sponsor
Seoul National University Bundang Hospital
Enrollment
68
Locations
1
Primary Endpoint
the Pediatric Anesthesia Emergence Delirium (PAED) Score
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
April 2015
End Date
April 2016
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

LEE YEA JI

clinical professor

Seoul National University Bundang Hospital

Eligibility Criteria

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

Outcomes

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.

Study Sites (1)

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