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

September 26, 2019 updated by: LEE YEA JI, Seoul National University Bundang Hospital

The Correlation Between 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

68

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyenggo-do
      • Seongnam, Gyenggo-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital, department of Anesthesia and pain

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients, aged between 3 and 5 years, scheduled for strabismus surgery

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
low Bispectral index (BIS) group
BIS range under 40
Device: BIS
BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient.
normal BIS group
BIS range from 40 to 60
Device: BIS
BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Investigators

  • Study Director: HYO SEOK NA, Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

August 10, 2015

First Submitted That Met QC Criteria

August 11, 2015

First Posted (Estimate)

August 13, 2015

Study Record Updates

Last Update Posted (Actual)

October 21, 2019

Last Update Submitted That Met QC Criteria

September 26, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-1503-289-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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