Does Emergence Time Relate With Emergence Agitation in Pediatric Patients?

Completed

• Conditions: Emergence Agitation, Post Operative Behavioral Changes

• Registration Number: NCT03358069
• Lead Sponsor: Prince of Songkla University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2013-12
• Study Completion: 2014-06
• Status Verified: 2017-11
• Study First Submitted: 2017-11-02
• Study First Submitted QC: 2017-11-29
• Last Update Submitted: 2017-11-29
• Study First Posted: 2017-11-30
• Last Update Posted: 2017-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
emergence agitation	evaluate patient within the first 5 minutes after patient arrive PACU	Pediatric Anesthesia Emergence delirium scale (PAED) PAED \> 10 defined as EA positive

Secondary Outcome Measures

Name	Time	Method
Post operative behavioral changes	up to 7 days postoperative period	PHBQ (post hospitalization behavioral questionnaires)

Trial Locations

Locations (1)

Prince of Songkla University; 🇹🇭 Hat Yai, Songkhla, Thailand