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

Not yet recruiting

• Conditions: Emergence Agitation; Children's Surgery; Anesthesia

• Registration Number: NCT06079710
• Lead Sponsor: Second Affiliated Hospital of Nanchang University

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-06
• Study First Submitted QC: 2023-10-06
• Last Update Submitted: 2023-10-06
• Study First Posted: 2023-10-12
• Last Update Posted: 2023-10-12
• Study Start: 2023-11-01
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of emergence agitation	The entire period from entering the recovery room to leaving the recovery room. Approximately 10 min-2 hours	The 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 Outcome Measures

Name	Time	Method
Postoperative pain intensity	The entire period from entering the recovery room to leaving the recovery room. Approximately 10 min-2 hours	Immediately 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 period	Anesthesia induction period, up to 2 minutes	The 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
emergence time	Approximately 5 min-2 hours	The 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.

Trial Locations

Locations (1)

Jiangxi Provincial Children's Hospital; 🇨🇳 Nanchang, Jiangxi Provincial, China