Emergence Agitation, Post Operative Behavioral ChangesNCT03358069
Does Emergence Time Relate With Emergence Agitation in Pediatric Patients?
An observational study of Emergence Agitation, Post Operative Behavioral Changes, run by Prince of Songkla University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Emergence Agitation, Post Operative Behavioral Changes
- What is being tested?
- Emergence agitation scale
- How many people
- 91 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2013to Jun 2014
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patient aged between 3-12 years
Who may be able to join
- Pediatric patient aged between 3-12 years, ASA physical status I-II who is scheduled for inpatient elective surgery
Who cannot join
- emergency surgery, neurosurgery, antiepileptic medication taken and having ICU admission planning.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Prince of Songkla University
Hat Yai, Changwat Songkhla, 90110
About this study
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.
Read more
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.
- Being tested
- Emergence agitation scale
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergence agitation scaleDiagnostic test
Also called Post operative behavioral changes
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
| Study group | Role | What they receive |
|---|---|---|
| deep anesthetic state | technique of Anesthesia at the time of airway device removal Receives: Diagnostic Test: Emergence agitation scale | |
| awake | technique of Anesthesia at the time of airway device removal Receives: 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 Receives: Diagnostic Test: Emergence agitation scale | |
| Emergence time (entropy): min | time from Entropy value above 60 to 90 Receives: Diagnostic Test: Emergence agitation scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
emergence agitation
Pediatric Anesthesia Emergence delirium scale (PAED) PAED > 10 defined as EA positive
Measured: evaluate patient within the first 5 minutes after patient arrive PACU
Secondary outcomes (1)
Post operative behavioral changes
PHBQ (post hospitalization behavioral questionnaires)
Measured: up to 7 days postoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study startJan 2013
- Primary completionDec 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence Agitation, Post Operative Behavioral ChangesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 91 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ngamjit Pattaravit, Prince of Songkla University
- Investigators
- Ngamjit Pattaravit, MD, Principal investigator, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03358069
- Sponsor's protocol ID
- PSU EA 3
- Status last verified
- Nov 2017
- First submitted
- 2 Nov 2017
- Last updated
- 30 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Emergence Time Relate With Emergence Agitation in Pediatric Patients?
- ClinicalTrials.gov ID
- NCT03358069
- Acronym / sponsor ID
- PSU EA 3
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 30 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| deep anesthetic state | – | Diagnostic Test: Emergence agitation scaletechnique of Anesthesia at the time of airway device removal |
| awake | – | Diagnostic Test: Emergence agitation scaletechnique of Anesthesia at the time of airway device removal |
| emergence time (clinical): min | – | Diagnostic Test: Emergence agitation scaleThe duration from the time of anesthestic medications stop and the time that patient spontaneously open their eyes |
| Emergence time (entropy): min | – | Diagnostic Test: Emergence agitation scaletime from Entropy value above 60 to 90 |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patient aged between 3-12 years
Key inclusion criteria (1 listed)
- Pediatric patient aged between 3-12 years, ASA physical status I-II who is scheduled for inpatient elective surgery
Key exclusion criteria (1 listed)
- emergency surgery, neurosurgery, antiepileptic medication taken and having ICU admission planning.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emergence agitation scaleAlso: Post operative behavioral changesEmergence 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 | Diagnostic test | Emergence time (entropy): min, awake, deep anesthetic state, emergence time (clinical): min |
Primary outcome
emergence agitation
Time frame: evaluate patient within the first 5 minutes after patient arrive PACU
Pediatric Anesthesia Emergence delirium scale (PAED) PAED > 10 defined as EA positive
1 secondary outcome
Post operative behavioral changes
Time frame: up to 7 days postoperative period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Emergence Agitation, Post Operative Behavioral Changes
Not yet recruitingPhase 4
Intranasal Dexmedetomidine or Esketamine for Negative Postoperative Behavioral Changes in Children
Behavior Problem
Recruiting
Efficacy of Ultrasound-guided Greater Auricular Nerve Block in Preventing Postoperative Emergence Agitation in Pediatric Patients Undergoing Microscopic Middle Ear Surgery.
Emergence Agitation, Emergence Delirium, Anesthesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ngamjit Pattaravit, MD principal investigator
Prince of Songkla University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergence Agitation, Post Operative Behavioral Changes, run by Prince of Songkla University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
emergence agitation (time frame: evaluate patient within the first 5 minutes after patient arrive PACU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2017.