Skip to content

Does Emergence Time Relate With Emergence Agitation in Pediatric Patients?

Does Emergence Time Relate With Emergence Agitation in Pediatric Patients?

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03358069
Enrollment
91
Registered
2017-11-30
Start date
2013-01-31
Completion date
2014-06-30
Last updated
2017-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergence Agitation, Post Operative Behavioral Changes

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.

Interventions

DIAGNOSTIC_TESTEmergence 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

Sponsors

Prince of Songkla University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
emergence agitationevaluate patient within the first 5 minutes after patient arrive PACUPediatric Anesthesia Emergence delirium scale (PAED) PAED \> 10 defined as EA positive

Secondary

MeasureTime frameDescription
Post operative behavioral changesup to 7 days postoperative periodPHBQ (post hospitalization behavioral questionnaires)

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026