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Clinical Trials/NCT03358069
NCT03358069
Completed
Not Applicable

Does Emergence Time Relate With Emergence Agitation in Pediatric Patients?

Prince of Songkla University1 site in 1 country91 target enrollmentJanuary 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Emergence Agitation, Post Operative Behavioral Changes
Sponsor
Prince of Songkla University
Enrollment
91
Locations
1
Primary Endpoint
emergence agitation
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
June 2014
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ngamjit Pattaravit

Asst. Prof.

Prince of Songkla University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

emergence agitation

Time Frame: evaluate patient within the first 5 minutes after patient arrive PACU

Pediatric Anesthesia Emergence delirium scale (PAED) PAED \> 10 defined as EA positive

Secondary Outcomes

  • Post operative behavioral changes(up to 7 days postoperative period)

Study Sites (1)

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