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Effect of Intraoperative and Awakening Electroencephalogram on Awakening Agitation After General Anesthesia in Children

Jiangxi Provincial Children's Hospital

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06079710
Enrollment
100
Registered
2023-10-12
Start date
2023-11-01
Completion date
2023-12-30
Last updated
2023-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Children's Surgery, Emergence Agitation

Brief summary

The purpose of this study was to analyze the relationship between intraoperative and awakening electroencephalogram waveforms and awakening agitation after general anesthesia in children

Interventions

None listed

Sponsors

Second Affiliated Hospital of Nanchang University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 10 Years
Healthy volunteers
No

Inclusion criteria

1. The age of the child is 1-10 years old, regardless of gender; 2. ASA grading I to II; 3. Children undergoing hernia, appendix, or small orthopedic surgery under selective general anesthesia

Exclusion criteria

1. Respiratory infection occurred within 1 week before surgery; 2. Potential or existing contraindications to general anesthesia; 3. Significant abnormalities in blood routine or biochemical indicators; 4. Patients with cognitive function, mental illness, or neurodevelopmental delay; 5. Unable to cooperate in completing the test, the child's guardian refused to participate; 6. Other reasons why researchers believe it is not suitable to participate in this experiment.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of emergence agitationThe entire period from entering the recovery room to leaving the recovery room. Approximately 10 min-2 hoursThe level of postoperative emergence agitation (EA) was assessed using the pediatric anesthesia emergence delirium Scale (PAED) and the emergence agitation 5 Scale immediately after extubation, and then every 15 min until the child was returned to the ward. emergence agitation was defined as a PAED score of ≥12 or a emergence agitation 5 scale of \>3.

Secondary

MeasureTime frameDescription
emergence timeApproximately 5 min-2 hoursThe period of time between the cessation of the use of anesthetic drugs and the recovery of the child's autonomous consciousness and the ability to respond correctly to external stimuli.
Postoperative pain intensityThe entire period from entering the recovery room to leaving the recovery room. Approximately 10 min-2 hoursImmediately after postoperative recovery, assess the pain intensity of the child using the FLACC pain scale, and then evaluate again every 15 minutes until the child leaves the recovery room. FLACC is divided into 0-10 points
Compatibility during anesthesia induction periodAnesthesia induction period, up to 2 minutesThe degree of cooperation between the patient and the doctor's instructions during anesthesia induction period. Using the Anesthesia Induction Cooperation Scale (ICC) for evaluation, the higher the ICC score, the worse the compatibility

Countries

China

Contacts

Primary ContactFuzhou Hua
huafuzhou@126.com+8615170238929
Backup ContactWei Wan
wanwei0207@163.com+8613767636004

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026