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

Completed

• Conditions: Strabismus
• Interventions: Device: BIS

• Registration Number: NCT02521259
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-08-10
• Study First Submitted QC: 2015-08-11
• Study First Posted: 2015-08-13
• Primary Completion: 2016-03
• Study Completion: 2016-04
• Results First Submitted: 2017-09-26
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-26
• Last Update Submitted: 2019-09-26
• Results First Posted: 2019-10-21
• Last Update Posted: 2019-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
normal BIS group	BIS	BIS range from 40 to 60
low Bispectral index (BIS) group	BIS	BIS range under 40

Primary Outcome Measures

Name	Time	Method
the Pediatric Anesthesia Emergence Delirium (PAED) Score	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.

Trial Locations

Locations (1)

Seoul National University Bundang Hospital, department of Anesthesia and pain; 🇰🇷 Seongnam, Gyenggo-do, Korea, Republic of