Does Emergence Time Relate With Emergence Agitation in Pediatric Patients?

Prince of Songkla University

Status: Completed

Conditions: Emergence Agitation, Post Operative Behavioral Changes

Treatments: Diagnostic Test: Emergence agitation scale

Study type: Observational

Funder types: Other

Identifiers

NCT03358069

PSU EA 3

Details and patient eligibility

About

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.

Enrollment: 91 patients

Sex: All

Ages: 3 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

91 participants in 4 patient groups

deep anesthetic state

Description:

technique of Anesthesia at the time of airway device removal

Treatment:

Diagnostic Test: Emergence agitation scale

awake

Description:

technique of Anesthesia at the time of airway device removal

Treatment:

Diagnostic Test: Emergence agitation scale

emergence time (clinical): min

Description:

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

Treatment:

Diagnostic Test: Emergence agitation scale

Emergence time (entropy): min

Description:

time from Entropy value above 60 to 90

Treatment:

Diagnostic Test: Emergence agitation scale