Mood Change After General Anesthesia in Children

NCT03581526 | Completed

• 1 other identifier: DCMC#4
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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 Items are categorized as following syndrome scales: Emotionally reactive, Anxious/Depressed, Somatic complaints, Withdrawn, Attention problems, Aggressive behavior, and sleep problems.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

Conditions

Anesthesia, General; Psychology, Child; Child Behavior

Outcome Measures

Primary Outcomes (5)

• 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 Questions are scored on syndrome scales designated as emotionally reactive, anxious/depressed, somatic complaints, withdrawn, attention problems, aggressive behavior, and sleep problems.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.

  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.

  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.

  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.

  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.

  Approximately during 60 min after PACU admission

Secondary Outcomes (5)

• modified Yale preoperative anxiety score (mYPAS)

  before anesthesia induction (about 30 min before the surgery)

• PAED score during PACU stay

  During 60 min after PACU admission

• Watcha scale on initial, 10, 20, and 30 min

  During 60 minutes after PACU admission

• FLACC score on initial, 10, 20, and 30 min

  During 60 minutes after PACU admission

• Postoperative adverse event

  During 60 minutes after the surgery

Eligibility Criteria

• Age: 2 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children aged between 2 and 7 years

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daegu Catholic University Medical Center: lead

Study Sites (2)

Daegu Catholic University Medical Center

Daegu, 42472, South Korea

Location

Hanyang University medical center

Seoul, 04763, South Korea

Location

MeSH Terms

Conditions

Child Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Eugene Kim, MD, PhD

  Assistant professor

  STUDY CHAIR

• JongHae Kim, MD

  Associate professor

  STUDY DIRECTOR

• Sooyeon Kim, MD

  Fellow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: July 10, 2018
• Study Start: July 10, 2018
• Primary Completion: April 19, 2020
• Study Completion: April 24, 2020
• Last Updated: June 16, 2020

Record last verified: 2020-06

Locations

KR (2)