Emergence Agitation, Post Operative Behavioral Changes Clinical Trial
Official title:
Does Emergence Time Relate With Emergence Agitation in Pediatric Patients?
| Verified date | November 2017 |
| Source | Prince of Songkla University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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.
| Status | Completed |
| Enrollment | 91 |
| Est. completion date | June 2014 |
| Est. primary completion date | December 2013 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 3 Years to 12 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Thailand | Prince of Songkla University | Hat Yai | Songkhla |
| Lead Sponsor | Collaborator |
|---|---|
| Prince of Songkla University |
Thailand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | emergence agitation | Pediatric Anesthesia Emergence delirium scale (PAED) PAED > 10 defined as EA positive | evaluate patient within the first 5 minutes after patient arrive PACU | |
| Secondary | Post operative behavioral changes | PHBQ (post hospitalization behavioral questionnaires) | up to 7 days postoperative period |