Emergence AgitationNCT06079710
Effect of Intraoperative and Awakening Electroencephalogram on Awakening Agitation After General Anesthesia in Children
An observational study of Emergence Agitation and Anesthesia, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
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 Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Emergence Agitation, Anesthesia, Children's Surgery
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Children who meet the inclusion criteria for surgery at Jiangxi Provincial Children's Hospital
Who may be able to join
- The age of the child is 1-10 years old, regardless of gender;
- ASA grading I to II;
- Children undergoing hernia, appendix, or small orthopedic surgery under selective general anesthesia
Who cannot join
- Respiratory infection occurred within 1 week before surgery;
- Potential or existing contraindications to general anesthesia;
- Significant abnormalities in blood routine or biochemical indicators;
- Patients with cognitive function, mental illness, or neurodevelopmental delay;
- Unable to cooperate in completing the test, the child's guardian refused to participate;
- Other reasons why researchers believe it is not suitable to participate in this experiment.
Trial locations and contacts
1 site in 1 country.
China1 site
Jiangxi Provincial Children's Hospital
Nanchang, Jiangxi Provincial, 330000
Fuzhou Hua, +8615170238929, huafuzhou@126.com
About this study
Official title: 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
- Conditions
- Emergence Agitation, Anesthesia, Children's Surgery
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Emergence agitation group | Not described | |
| Non emergence agitation group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The entire period from entering the recovery room to leaving the recovery room. Approximately 10 min-2 hours
Secondary outcomes (3)
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.
Measured: Approximately 5 min-2 hours
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
Measured: The entire period from entering the recovery room to leaving the recovery room. Approximately 10 min-2 hours
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
Measured: Anesthesia induction period, up to 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence AgitationStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Nanchang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fuzhou Hua, Second Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06079710
- Sponsor's protocol ID
- 2023-EEG-children
- Status last verified
- Oct 2023
- First submitted
- 6 Oct 2023
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Jiangxi Provincial Children's Hospital
- ClinicalTrials.gov ID
- NCT06079710
- Acronym / sponsor ID
- 2023-EEG-children
- Conditions
- Emergence Agitation, Anesthesia, Children's Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emergence agitation group | – | – |
| Non emergence agitation group | – | – |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children who meet the inclusion criteria for surgery at Jiangxi Provincial Children's Hospital
Key inclusion criteria (3 listed)
- The age of the child is 1-10 years old, regardless of gender;
- ASA grading I to II;
- Children undergoing hernia, appendix, or small orthopedic surgery under selective general anesthesia
Key exclusion criteria (6 listed)
- Respiratory infection occurred within 1 week before surgery;
- Potential or existing contraindications to general anesthesia;
- Significant abnormalities in blood routine or biochemical indicators;
- Patients with cognitive function, mental illness, or neurodevelopmental delay;
- Unable to cooperate in completing the test, the child's guardian refused to participate;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
emergence time
Time frame: 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
Compatibility during anesthesia induction period
Time frame: Anesthesia induction period, up to 2 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergence Agitation and Anesthesia, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fuzhou Hua (+8615170238929, huafuzhou@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of emergence agitation (time frame: The entire period from entering the recovery room to leaving the recovery room. Approximately 10 min-2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023.