Clinical trial NCT03358069: Does Emergence Time Relate With Emergence Agitation in Pediatric Patients?
Official title: Does Emergence Time Relate With Emergence Agitation in Pediatric Patients?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergence Agitation, Post Operative Behavioral Changes
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2017-11-30
Enrollment: 91
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patient aged between 3-12 years

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.


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.

Primary outcomes:
measure: emergence agitation
timeFrame: evaluate patient within the first 5 minutes after patient arrive PACU
Secondary outcomes:
measure: Post operative behavioral changes
timeFrame: up to 7 days postoperative period
Other outcomes:
Locations:
city: Hat Yai
country: Thailand
facility: Prince of Songkla University
state: Songkhla
Study officials:
affiliation: Prince of Songkla University
name: Ngamjit Pattaravit, MD
role: PRINCIPAL_INVESTIGATOR
References: