Mood Change After General Anesthesia in Children

Anesthesia, General Clinical Trial

Official title:

Psychological and Behavioral Change Before and After General Anesthesia in Preschool Children: Preliminary Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03581526
• Other study ID #: DCMC#4
• Status: Completed
• Start date: July 10, 2018
• Est. completion date: April 24, 2020

Study information

• Verified date: June 2020
• Source: Daegu Catholic University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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 Items are categorized as following syndrome scales: Emotionally reactive, Anxious/Depressed, Somatic complaints, Withdrawn, Attention problems, Aggressive behavior, and sleep problems.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 24, 2020
• Est. primary completion date: April 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, General
• Child Behavior
• Psychology, Child

Locations

Country	Name	City	State
Korea, Republic of	Daegu Catholic University Medical Center	Daegu
Korea, Republic of	Hanyang University medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Daegu Catholic University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	modified Yale preoperative anxiety score (mYPAS)	mYPAS is the assessment tool for measure the anxiety before induction. Higher score indicates higher anxiety.	before anesthesia induction (about 30 min before the surgery)
Secondary	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.	During 60 min after PACU admission
Secondary	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	During 60 minutes after PACU admission
Secondary	FLACC score on initial, 10, 20, and 30 min	Face, legs, activity, cry, and consolability (FLACC) score is checked every 10min after PACU admission	During 60 minutes after PACU admission
Secondary	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.	During 60 minutes after the surgery