Mood Change After General Anesthesia in Children

NCT ID: NCT03581526

Last Updated: 2020-06-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-07-10
• Study Completion Date: 2020-04-24

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 Items are categorized as following syndrome scales: Emotionally reactive, Anxious/Depressed, Somatic complaints, Withdrawn, Attention problems, Aggressive behavior, and sleep problems.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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daegu Catholic University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Eugene Kim

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eugene Kim, MD, PhD

Role: STUDY_CHAIR

Assistant professor

JongHae Kim, MD

Role: STUDY_DIRECTOR

Associate professor

Sooyeon Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Fellow

Locations

Daegu Catholic University Medical Center

Daegu, , South Korea

Hanyang University medical center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

DCMC#4

Identifier Type: -

Identifier Source: org_study_id