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

October 6, 2023 updated by: Fuzhou Hua, Second Affiliated Hospital of Nanchang University

Jiangxi Provincial Children's Hospital

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

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangxi Provincial
      • Nanchang, Jiangxi Provincial, China, 330000
        • Jiangxi Provincial Children's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Children who meet the inclusion criteria for surgery at Jiangxi Provincial Children's Hospital

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Emergence agitation group
Non emergence agitation group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of emergence agitation
Time Frame: 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.
The entire period from entering the recovery room to leaving the recovery room. Approximately 10 min-2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
emergence time
Time Frame: 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.
Approximately 5 min-2 hours
Postoperative pain intensity
Time Frame: 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
The entire period from entering the recovery room to leaving the recovery room. Approximately 10 min-2 hours
Compatibility during anesthesia induction period
Time Frame: 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
Anesthesia induction period, up to 2 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Nanchang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 30, 2023

Study Registration Dates

First Submitted

October 6, 2023

First Submitted That Met QC Criteria

October 6, 2023

First Posted (Actual)

October 12, 2023

Study Record Updates

Last Update Posted (Actual)

October 12, 2023

Last Update Submitted That Met QC Criteria

October 6, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-EEG-children

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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