Does Emergence Time Relate With Emergence Agitation in Pediatric Patients?

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.

Study Overview

• Status: Completed
• Conditions: Emergence Agitation, Post Operative Behavioral Changes
• Intervention / Treatment: Diagnostic test: Emergence agitation scale

• Study Type: Observational
• Enrollment (Actual): 91

Contacts and Locations

Study Locations

• Thailand
  • Songkhla
    • Hat Yai, Songkhla, Thailand, 90110
      • Prince of Songkla University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pediatric patient aged between 3-12 years

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
deep anesthetic state; technique of Anesthesia at the time of airway device removal	Diagnostic test: Emergence 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; Other Names: Post operative behavioral changes
awake; technique of Anesthesia at the time of airway device removal	Diagnostic test: Emergence 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; Other Names: Post operative behavioral changes
emergence time (clinical): min; The duration from the time of anesthestic medications stop and the time that patient spontaneously open their eyes	Diagnostic test: Emergence 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; Other Names: Post operative behavioral changes
Emergence time (entropy): min; time from Entropy value above 60 to 90	Diagnostic test: Emergence 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; Other Names: Post operative behavioral changes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post operative behavioral changes	PHBQ (post hospitalization behavioral questionnaires)	up to 7 days postoperative period

Collaborators and Investigators

• Sponsor: Prince of Songkla University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2013
• Primary Completion (ACTUAL): December 1, 2013
• Study Completion (ACTUAL): June 1, 2014

Study Registration Dates

• First Submitted: November 2, 2017
• First Submitted That Met QC Criteria: November 29, 2017
• First Posted (ACTUAL): November 30, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 30, 2017
• Last Update Submitted That Met QC Criteria: November 29, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Dyskinesias; Psychomotor Disorders; Delirium; Psychomotor Agitation; Emergence Delirium
• Other Study ID Numbers: PSU EA 3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No