Does Emergence Time Relate With Emergence Agitation in Pediatric Patients?

NCT03358069 | Completed DMC

• 1 other identifier: PSU EA 3
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Emergence Agitation, Post Operative Behavioral Changes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Post operative behavioral changes

  up to 7 days postoperative period

Study Arms (4)

deep anesthetic state

technique of Anesthesia at the time of airway device removal

Diagnostic Test: Emergence agitation scale

awake

technique of Anesthesia at the time of airway device removal

Diagnostic Test: Emergence agitation scale

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 time (entropy): min

time from Entropy value above 60 to 90

Diagnostic Test: Emergence agitation scale

Interventions

Emergence agitation scale DIAGNOSTIC_TEST

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

Also known as: Post operative behavioral changes

Emergence time (entropy): min; awake; deep anesthetic state; emergence time (clinical): min

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patient aged between 3-12 years

You may qualify if:

• Pediatric patient aged between 3-12 years, ASA physical status I-II who is scheduled for inpatient elective surgery

You may not qualify if:

• emergency surgery, neurosurgery, antiepileptic medication taken and having ICU admission planning.

Sponsors & Collaborators

• Prince of Songkla University: lead

Study Sites (1)

Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Ngamjit Pattaravit, MD

  Prince of Songkla University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: November 2, 2017
• First Posted: November 30, 2017
• Study Start: January 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: November 30, 2017

Record last verified: 2017-11

Locations

TH (1)