Clinical trial NCT03581526: Mood Change After General Anesthesia in Children
Official title: Psychological and Behavioral Change Before and After General Anesthesia in Preschool Children: Preliminary Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia, General
Psychology, Child
Child Behavior
Lead sponsor: Daegu Catholic University Medical Center
Sponsor class: OTHER
First posted: 2018-07-10
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children aged between 2 and 7 years

Brief 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. 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 Items are categorized as following syndrome scales: Emotionally reactive, Anxious/Depressed, Somatic complaints, Withdrawn, Attention problems, Aggressive behavior, and sleep problems.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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change of T-score of total score of child behavior checklist 1.5-5 (CBCL 1.5-5)
timeFrame: before anesthesia induction and 1 week after the surgery
measure: Change of T-score of each internalizing problems
timeFrame: before anesthesia induction and 1 week after the surgery
measure: Change of T-score of each externalizing problems
timeFrame: before anesthesia induction and 1 week after the surgery
measure: Change of T-score of sleep problems
timeFrame: before anesthesia induction and 1 week after the surgery
measure: Emergence Delirium (ED)
timeFrame: Approximately during 60 min after PACU admission
Secondary outcomes:
measure: modified Yale preoperative anxiety score (mYPAS)
timeFrame: before anesthesia induction (about 30 min before the surgery)
measure: PAED score during PACU stay
timeFrame: During 60 min after PACU admission
measure: Watcha scale on initial, 10, 20, and 30 min
timeFrame: During 60 minutes after PACU admission
measure: FLACC score on initial, 10, 20, and 30 min
timeFrame: During 60 minutes after PACU admission
measure: Postoperative adverse event
timeFrame: During 60 minutes after the surgery
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Seoul
country: Korea, Republic of
facility: Hanyang University medical center
Study officials:
affiliation: Assistant professor
name: Eugene Kim, MD, PhD
role: STUDY_CHAIR
affiliation: Associate professor
name: JongHae Kim, MD
role: STUDY_DIRECTOR
affiliation: Fellow
name: Sooyeon Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: