Anesthesia, GeneralNCT03581526
Mood Change After General Anesthesia in Children
An observational study of Anesthesia, General and Psychology, Child, run by Daegu Catholic University Medical Center at 2 sites in South Korea.
Trial summary
Most drugs used in general anesthesia work on various receptors in the human brain, causing unconsciousness, loss of memory, and loss of reflection of the autonomic nervous system. After the anesthesia, baseline physiological function will be attained by administration of some reversal drugs or as the time goes by. Read more about this study
- Who is it for?
- Ages 2 to 7 years
- Conditions the study is for
- Anesthesia, General, Psychology, Child, Child Behavior
- How many people
- 100 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 10 Jul 2018to 24 Apr 2020
- 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 2 to 7 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged between 2 and 7 years
Who may be able to join
- Children aged between 2 and 7 years of American Society of Anesthesiologists physical status (ASA PS) I or II who are planned to receive surgery under general anesthesia
Who cannot join
- If the guardian and the subject are difficult to evaluate normally due to language barriers/language disorders/delay or autistic disorder
- with developmental delay, neurological disorders or psychiatric diseases associated with symptoms of agitation, anxiety, attention deficit, sleep disturbances, etc
- refusal of consent
- Any visual or auditory problems of the primary responder of CBCL
- recently received psychiatric medication or sleep supplements
- Recent history (within a month) of received general anesthesia or surgery
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Daegu Catholic University Medical Center
Daegu, 42472
Hanyang University medical center
Seoul, 04763
About this study
Official title: Psychological and Behavioral Change Before and After General Anesthesia in Preschool Children: Preliminary Study
Most drugs used in general anesthesia work on various receptors in the human brain, causing unconsciousness, loss of memory, and loss of reflection of the autonomic nervous system. After the anesthesia, baseline physiological function will be attained by administration of some reversal drugs or as the time goes by. In this process, various side effects may occur.
Emergence delirium (ED) is a representative behavioral disturbance after general anesthesia in children and that can cause several problems during the recovery period. Previous studies found that ED and postoperative behavioral problems might be connected. Preschoolers are the most vulnerable group in developing ED after general anesthesia, however, it is difficult to evaluate the psychiatric problems at this age.
Read more
The Child Behavior Checklist (CBCL) 1.5-5 is an internationally well-known standardized tool for assessment of developmental psychopathology, consisted of 99 problem items. Items are categorized as following syndrome scales: Emotionally reactive, Anxious/Depressed, Somatic complaints, Withdrawn, Attention problems, Aggressive behavior, and sleep problems.
In this study, the investigators would observe the behavioral and emotional changes of the child using the CBCL 1.5-5 between before and after the general anesthesia.
- Conditions
- Anesthesia, General, Psychology, Child, Child Behavior
- Medical subject headings
- Child Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of T-score of total score of child behavior checklist 1.5-5 (CBCL 1.5-5)
T-score is the scale in order to indicate the relative position within the whole group that has been standardized, the average and standard deviation of the percentile distribution obtained through the origin sum of score. The CBCL 1.5-5 included 99 questions that describe specific kinds of behavioral and emotional problems for preschool children. Questions are scored on syndrome scales designated as emotionally reactive, anxious/depressed, somatic complaints, withdrawn, attention problems, aggressive behavior, and sleep problems. Higher scores mean great behavioral disturbances.
Measured: before anesthesia induction and 1 week after the surgery
Change of T-score of each internalizing problems
T-score is the scale in order to indicate the relative position within the whole group that has been standardized, the average and standard deviation of the percentile distribution obtained through the origin sum of score. Internalizing problems are consisted of following 4 categories : emotionally reactive, withdrawn, somatic complaints, and anxious/depressed.
The subjects are asked to answer the questions with a 3 point scale:
0 for not true of the child; 1 for somewhat or sometimes true, and 2 for very true of often true. The scores for problems were calculated according to the CBCL manuals. Higher scores mean great behavioral disturbances.
Measured: before anesthesia induction and 1 week after the surgery
Change of T-score of each externalizing problems
T-score is the scale in order to indicate the relative position within the whole group that has been standardized, the average and standard deviation of the percentile distribution obtained through the origin sum of score.
Externalizing problems are consisted of following 2 categories : Attention problems and aggressive behavior.
The subjects are asked to answer the questions with a 3 point scale:
0 for not true of the child; 1 for somewhat or sometimes true, and 2 for very true of often true. The scores for problems were calculated according to the CBCL manuals. Higher scores mean great behavioral disturbances.
Measured: before anesthesia induction and 1 week after the surgery
Change of T-score of sleep problems
T-score is the scale in order to indicate the relative position within the whole group that has been standardized, the average and standard deviation of the percentile distribution obtained through the origin sum of score. The subjects are asked to answer the questions with a 3 point scale:
0 for not true of the child; 1 for somewhat or sometimes true, and 2 for very true of often true. The scores for problems were calculated according to the CBCL manuals. Higher scores mean great behavioral disturbances.
Measured: before anesthesia induction and 1 week after the surgery
Emergence Delirium (ED)
Whether ED is occurs during PACU stay in children. The determination of ED was made using parameters PAED >12 and Watcha >2.
Measured: Approximately during 60 min after PACU admission
Secondary outcomes (5)
modified Yale preoperative anxiety score (mYPAS)
mYPAS is the assessment tool for measure the anxiety before induction. Higher score indicates higher anxiety.
Measured: before anesthesia induction (about 30 min before the surgery)
PAED score during PACU stay
On arrival at post-anesthesia care unit (PACU) and every 10 min from then, patients were checked PAED. The PAED scale is a validated observational measure of 5 aspects of child behavior (caregiver eye contact, purposeful movement, evidence of awareness of surroundings, restlessness, and inconsolability). Ratings are summed to produce a total score ranging from 0 to 20; greater scores indicate greater severity.
Measured: During 60 min after PACU admission
Watcha scale on initial, 10, 20, and 30 min
On arrival and 10, 20, and 30 min after PACU admission, patients were checked Watcha scale as following 4-point scale
calm crying, but can be consoled Crying, cannot be consoled Agitated and thrashing around
Measured: During 60 minutes after PACU admission
FLACC score on initial, 10, 20, and 30 min
Face, legs, activity, cry, and consolability (FLACC) score is checked every 10min after PACU admission
Measured: During 60 minutes after PACU admission
Postoperative adverse event
After the end of surgery, postoperative adverse events (such as postoperative dizziness, sore throat, abdominal pain, breath holding, coughing, desaturation, laryngospasm, and bronchospasm) are checked during emergence period and PACU stay.
Measured: During 60 minutes after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start10 Jul 2018
- Primary completion19 Apr 2020
- Study completion24 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, GeneralStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daegu Catholic University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eugene Kim, Daegu Catholic University Medical Center
- Investigators
- Eugene Kim, MD, PhD, Study chair, Assistant professorJongHae Kim, MD, Study director, Associate professorSooyeon Kim, MD, Principal investigator, Fellow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03581526
- Sponsor's protocol ID
- DCMC#4
- Status last verified
- Jun 2020
- First submitted
- 26 Jun 2018
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological and Behavioral Change Before and After General Anesthesia in Preschool Children: Preliminary Study
- ClinicalTrials.gov ID
- NCT03581526
- Acronym / sponsor ID
- DCMC#4
- Conditions
- Anesthesia, General, Psychology, Child, Child Behavior
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Daegu Catholic University Medical CenterUniversity, hospital or other
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 19 Apr 2020 (actual)
- Study completion
- 24 Apr 2020 (actual)
- First posted
- 10 Jul 2018 (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.
Most drugs used in general anesthesia work on various receptors in the human brain, causing unconsciousness, loss of memory, and loss of reflection of the autonomic nervous system. After the anesthesia, baseline physiological function will be attained by administration of some reversal drugs or as the time goes by. In this process, various side effects may occur.
Emergence delirium (ED) is a representative behavioral disturbance after general anesthesia in children and that can cause several problems during the recovery period. Previous studies found that ED and postoperative behavioral problems might be connected. Preschoolers are the most vulnerable group in developing ED after general anesthesia, however, it is difficult to evaluate the psychiatric problems at this age.
The Child Behavior Checklist (CBCL) 1.5-5 is an internationally well-known standardized tool for assessment of developmental psychopathology, consisted of 99 problem items. Items are categorized as following syndrome scales: Emotionally reactive, Anxious/Depressed, Somatic complaints, Withdrawn, Attention problems, Aggressive behavior, and sleep problems.
In this study, the investigators would observe the behavioral and emotional changes of the child using the CBCL 1.5-5 between before and after the general anesthesia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged between 2 and 7 years
Key inclusion criteria (1 listed)
- Children aged between 2 and 7 years of American Society of Anesthesiologists physical status (ASA PS) I or II who are planned to receive surgery under general anesthesia
Key exclusion criteria (6 listed)
- If the guardian and the subject are difficult to evaluate normally due to language barriers/language disorders/delay or autistic disorder
- with developmental delay, neurological disorders or psychiatric diseases associated with symptoms of agitation, anxiety, attention deficit, sleep disturbances, etc
- refusal of consent
- Any visual or auditory problems of the primary responder of CBCL
- recently received psychiatric medication or sleep supplements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of T-score of total score of child behavior checklist 1.5-5 (CBCL 1.5-5)
Time frame: before anesthesia induction and 1 week after the surgery
T-score is the scale in order to indicate the relative position within the whole group that has been standardized, the average and standard deviation of the percentile distribution obtained through the origin sum of score. The CBCL 1.5-5 included 99 questions that describe specific kinds of behavioral and emotional problems for preschool children. Questions are scored on syndrome scales designated as emotionally reactive, anxious/depressed, somatic complaints, withdrawn, attention problems, aggressive behavior, and sleep problems. Higher scores mean great behavioral disturbances.
Change of T-score of each internalizing problems
Time frame: before anesthesia induction and 1 week after the surgery
T-score is the scale in order to indicate the relative position within the whole group that has been standardized, the average and standard deviation of the percentile distribution obtained through the origin sum of score. Internalizing problems are consisted of following 4 categories : emotionally reactive, withdrawn, somatic complaints, and anxious/depressed. The subjects are asked to answer the questions with a 3 point scale: 0 for not true of the child; 1 for somewhat or sometimes true, and 2 for very true of often true. The scores for problems were calculated according to the CBCL manuals. Higher scores mean great behavioral disturbances.
Change of T-score of each externalizing problems
Time frame: before anesthesia induction and 1 week after the surgery
T-score is the scale in order to indicate the relative position within the whole group that has been standardized, the average and standard deviation of the percentile distribution obtained through the origin sum of score. Externalizing problems are consisted of following 2 categories : Attention problems and aggressive behavior. The subjects are asked to answer the questions with a 3 point scale: 0 for not true of the child; 1 for somewhat or sometimes true, and 2 for very true of often true. The scores for problems were calculated according to the CBCL manuals. Higher scores mean great behavioral disturbances.
Change of T-score of sleep problems
Time frame: before anesthesia induction and 1 week after the surgery
T-score is the scale in order to indicate the relative position within the whole group that has been standardized, the average and standard deviation of the percentile distribution obtained through the origin sum of score. The subjects are asked to answer the questions with a 3 point scale: 0 for not true of the child; 1 for somewhat or sometimes true, and 2 for very true of often true. The scores for problems were calculated according to the CBCL manuals. Higher scores mean great behavioral disturbances.
Emergence Delirium (ED)
Time frame: Approximately during 60 min after PACU admission
Whether ED is occurs during PACU stay in children. The determination of ED was made using parameters PAED >12 and Watcha >2.
5 secondary outcomes
modified Yale preoperative anxiety score (mYPAS)
Time frame: before anesthesia induction (about 30 min before the surgery)
PAED score during PACU stay
Time frame: During 60 min after PACU admission
Watcha scale on initial, 10, 20, and 30 min
Time frame: During 60 minutes after PACU admission
FLACC score on initial, 10, 20, and 30 min
Time frame: During 60 minutes after PACU admission
Postoperative adverse event
Time frame: During 60 minutes after the surgery
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 16 Jun 2020.
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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.
Eugene Kim, MD, PhD study chair
Assistant professor
JongHae Kim, MD study director
Associate professor
Sooyeon Kim, MD principal investigator
Fellow
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, General and Psychology, Child, run by Daegu Catholic University Medical Center at 2 sites in South Korea.
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 6 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 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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?
Change of T-score of total score of child behavior checklist 1.5-5 (CBCL 1.5-5) (time frame: before anesthesia induction and 1 week after the surgery). The study lists 5 primary outcomes in all. 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 16 Jun 2020.