Does Emergence Time Relate With Emergence Agitation in Pediatric Patients?

NCT ID: NCT03358069

Last Updated: 2017-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

91 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-06-30

Brief Summary

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Emergence agitation (EA) is one of the unpleasant symptoms after general anesthesia. The patient can be irritable, uncooperate, cry, moan and combative behaviors. Sometimes the patient may need to be thrashed to prevent physical harm. The mechanism of EA is still unknown. EA is usually self limiting within 45 to 60 minutes after wake up from anesthesia. The incidence of EA is much higher in pediatric group when compared with adult. In some centre the incidence of EA can be up to 67 % depends on anesthesia technique, race, and child's temperament. Kain et al, reported that the patient who had marked EA tended to have post operative maladaptive behaviors. These maladaptive behaviors such as insomnia, eating disturbance, aggressive behavior and even developmental regression can be happen until one year after anesthesia.

From the previous study, reported that fast emergence was associated with a high incidence of agitation.

This prospective observation study is conducted to determine that emergence time has any effect on EA or not. The authors use process electroencephalogram (entropy) to monitor emergence time which defined as the time which state entropy level over sixty to eighty. Meanwhile, we will evaluate the emergence time by the conventional method which used the time from ceasing anesthesia to the time of eye opening by normal voice stimuli.

The primary outcome of this study is the correlation between emergence time (both from Process EEG and clinical presentation) and incidence of emergence agitation. Two secondary outcomes will be measured. Firstly, the correlation between emergence time and postoperative behavioral changes. Secondly, the relationship between entropy monitoring and clinical symptoms.

Detailed Description

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Conditions

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Emergence Agitation, Post Operative Behavioral Changes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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deep anesthetic state

technique of Anesthesia at the time of airway device removal

Emergence agitation scale

Intervention Type DIAGNOSTIC_TEST

Emergence agitation scale: PAED scale \> 10 defined as positive for Emergence agitation (EA) Post hospitalize behavioral questionnaire (PHBQ) positive Post operative behavioral changes defines as 10 % change from sum score of PHBQ

awake

technique of Anesthesia at the time of airway device removal

Emergence agitation scale

Intervention Type DIAGNOSTIC_TEST

Emergence agitation scale: PAED scale \> 10 defined as positive for Emergence agitation (EA) Post hospitalize behavioral questionnaire (PHBQ) positive Post operative behavioral changes defines as 10 % change from sum score of PHBQ

emergence time (clinical): min

The duration from the time of anesthestic medications stop and the time that patient spontaneously open their eyes

Emergence agitation scale

Intervention Type DIAGNOSTIC_TEST

Emergence agitation scale: PAED scale \> 10 defined as positive for Emergence agitation (EA) Post hospitalize behavioral questionnaire (PHBQ) positive Post operative behavioral changes defines as 10 % change from sum score of PHBQ

Emergence time (entropy): min

time from Entropy value above 60 to 90

Emergence agitation scale

Intervention Type DIAGNOSTIC_TEST

Emergence agitation scale: PAED scale \> 10 defined as positive for Emergence agitation (EA) Post hospitalize behavioral questionnaire (PHBQ) positive Post operative behavioral changes defines as 10 % change from sum score of PHBQ

Interventions

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Emergence agitation scale

Emergence agitation scale: PAED scale \> 10 defined as positive for Emergence agitation (EA) Post hospitalize behavioral questionnaire (PHBQ) positive Post operative behavioral changes defines as 10 % change from sum score of PHBQ

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Post operative behavioral changes

Eligibility Criteria

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Inclusion Criteria

Pediatric patient aged between 3-12 years, ASA physical status I-II who is scheduled for inpatient elective surgery

Exclusion Criteria

emergency surgery, neurosurgery, antiepileptic medication taken and having ICU admission planning.
Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prince of Songkla University

OTHER

Sponsor Role lead

Responsible Party

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Ngamjit Pattaravit

Asst. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ngamjit Pattaravit, MD

Role: PRINCIPAL_INVESTIGATOR

Prince of Songkla University

Locations

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Prince of Songkla University

Hat Yai, Changwat Songkhla, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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PSU EA 3

Identifier Type: -

Identifier Source: org_study_id