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

Strabismus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02521259
• Other study ID #: B-1503-289-004
• Status: Completed
• Start date: April 2015
• Est. completion date: April 2016

Study information

• Verified date: September 2019
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Emergence Delirium
• Psychomotor Agitation
• Strabismus

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital, department of Anesthesia and pain	Seongnam	Gyenggo-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the Pediatric Anesthesia Emergence Delirium (PAED) Score	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.	30 minutes