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

Anesthesia Clinical Trial

Official title:

Jiangxi Provincial Children's Hospital

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06079710
• Other study ID #: 2023-EEG-children
• Status: Not yet recruiting
• Start date: November 1, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: October 2023
• Source: Second Affiliated Hospital of Nanchang University
• Contact: Fuzhou Hua
• Phone: +8615170238929
• Email: huafuzhou[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 30, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Emergence Agitation
• Emergence Delirium
• Psychomotor Agitation

Locations

Country	Name	City	State
China	Jiangxi Provincial Children's Hospital	Nanchang	Jiangxi Provincial

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Nanchang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of emergence agitation	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.	The entire period from entering the recovery room to leaving the recovery room. Approximately 10 min-2 hours
Secondary	emergence time	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.	Approximately 5 min-2 hours
Secondary	Postoperative pain intensity	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	The entire period from entering the recovery room to leaving the recovery room. Approximately 10 min-2 hours
Secondary	Compatibility during anesthesia induction period	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	Anesthesia induction period, up to 2 minutes