ElectroencephalographyNCT06580028

The EEG Study Under Sevoflurane Anesthesia in Children

An observational study of Electroencephalography and Sevoflurane, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.

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Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 1 day to 6 yearsHealthy volunteers can take part
Conditions the study is for: Electroencephalography, Sevoflurane, Child Neglect
How many people: 280 participants
Where: 1 siteChina
Study dates: 4 Sep 2024to Sep 2026
Phase: Observational
Are there results?: Not yet: the study is under way

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 day to 6 years
All sexes
Healthy volunteers accepted
Child

Study population: The study population met the above inclusion criteria.

Who may be able to join

aged 1 days#6 years#;
with American Society of Anesthesiologists (ASA) physical status I or II#;
children requiring general anesthesia under sevoflurane;
parents or legal guardians of children who volunteered to participate in the trial; And signed the informed consent form.

Who cannot join

Congenital malformation or other genetic conditions that are thought to affect brain development ;
History of severe heart, brain, liver, kidney and metabolic diseases ;
Premature infants (≤32 weeks);
Upper respiratory tract infection in the last two weeks.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Huacheng Liu contact

Yuhang Cai contact

China1 site, 1 recruiting

The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
Huacheng Liu, 13957770577, huachengliu@163.com
Yuhang Cai, 18815091585, 838097626@qq.com
Recruiting

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About this study

Official title: Electroencephalogram Study in Children Under Sevoflurane Anesthesia - a Prospective,Observational Study

Sevoflurane is one of the most commonly used volatile anesthetics in children because of its rapid induction, recovery and recovery properties. Clinical studies using noninvasive brain monitoring have shown that general anesthetics and hypnotics generate electroencephalogram (EEG) oscillations in specific spatial tissues that are fundamentally related to the structure and function of neural circuits. Slow-wave-delta (0.1-4 Hz) oscillations were present in children of all ages, and the advantage of frontal α-wave oscillations appeared at approximately 6 months, began to be consistent at 10 months, and persisted at older ages. Another study, which analyzed EEG under sevoflurane general anesthesia in children aged 0-6 months, found that Theta and alpha wave power decreased with a decrease in sevoflurane concentrations in infants between 4 and 6 months of recovery. However, these studies lack detailed characterization of the neural circuit activity associated with anesthesia, especially at specific developmental ages that are highly correlated with brain plasticity. The aim of this study was to explore electroencephalogram (EEG) of children of different ages under sevoflurane general anesthesia (including anesthesia induction, maintenance and recovery) . By analyzing these EEG data in detail, we hope to be able to better understand the EEG characteristics of children of different ages under sevoflurane anesthesia, and thus develop a neurophysiology pediatric anesthesia status monitoring strategy.

Read the detailed description

This study is prospective and observational. Children under sevoflurane general anesthesia were divided into 14 groups (0-3 months old, 3-6 months old, 6-9 months old, 9-12 months old, 1-1.5 years old, 1.5-2 years old, 2-2.5 years old, 2.5-3 years old, 3-3.5 years old, 3.5-4 years old, 4-4.5 years old, 4.5.5 years old, 5.5.5 years old, 5.5-6 years old) , there were 20 cases in each group. Inform the family about the research plan and obtain informed consent. To observe the time-frequency characteristics of prefrontal electroencephalogram (EEG) in children of different ages under general anesthesia with sevoflurane.

Conditions: Electroencephalography, Sevoflurane, Child Neglect
Keywords: Sevoflurane, Children, Electroencephalogram

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06580028
Study group	Role	What they receive
0-3 months		EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
3-6 months		EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
6-9 months		EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
9-12 months		EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
1-1.5 years		EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
1.5-2 years		EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
2-2.5 years		EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
2.5-3 years		EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
3-3.5 years		EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
3.5-4 years		EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
4-4.5 years		EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
4.5-5 years		EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
5-5.5 years		EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
5.5-6 years		EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.

What is being measured

The primary outcome is the main question the study is designed to answer.

Time-frequency characteristics of electroencephalogram (EEG)
Time-frequency characteristics of electroencephalogram (EEG) in children of different ages during sevoflurane general anesthesia (including anesthesia induction, maintenance and recovery) .
Measured: during sevoflurane general anesthesia (including anesthesia induction, maintenance and recovery)

Secondary outcomes (5)

Modified observer's assessment of alertness#sedation#MOAA/S#scale
5#Subject responds readily to name spoken in a normal tone; 4 #Lethargic response of a subject to a name spoken in a normal tone; 3 #The subject responds only after a name is called loudly and repeatedly; 2 #The subject responds only after mild prodding or shaking;
1 #The subject responds only after a painful trapezius squeeze; 0 #The subject does not respond to painful trapezius squeeze. MOAA/S score ≤ 2 points represent successful sedation
Measured: during sevoflurane general anesthesia (including anesthesia induction, maintenance and recovery)
Recovery time
From the time sevoflurane was stopped until the child opened his eyes for the first time and reached an Aldrete score of ≥9
Measured: Within up to 30 minutes after operation
Pediatric anesthesia emergence delirium
The pediatric anesthesia emergence delirium scale consists of four items. Each item is scored 0-4 yielding a total between 0 and 20.
Measured: Within up to 30 minutes after operation
The Face, Legs, Activity, Cry, Consolability Scale (FLACC)
The FLACC scale consists of five items. Each item is scored 0-2 yielding a total between 0 and 10.
Measured: Within up to 30 minutes after operation
PHBQ-AS
Post-Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS) is a parental report measure used to assess negative behavior change after hospitalization, consisting of 11 items on 1-5 score. The PHBQ-AS score will be calculated for each respondent as the mean score of all individual items answered on the questionnaire.
A score above 3 will indicate the presence of negative behavioral change, a score equal to 3 will indicate no behavioral change, and a score below 3 will indicate an improvement in behavior.
Measured: 3 days after operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Sep 2024Sep 2026

First posted30 Aug 2024
Study start4 Sep 2024
Primary completionSep 2026 (estimated)
Study completionSep 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ElectroencephalographyStudies of the same condition, open and under way.
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: 280 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06580028
Sponsor's protocol ID: SAHoWMU-CR2024-03-217
Status last verified: Feb 2025
First submitted: 28 Aug 2024
Last updated: 7 Feb 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

Huacheng Liu

13957770577

huachengliu@163.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Electroencephalogram Study in Children Under Sevoflurane Anesthesia - a Prospective,Observational Study
ClinicalTrials.gov ID: NCT06580028
Acronym / sponsor ID: SAHoWMU-CR2024-03-217
Conditions: Electroencephalography, Sevoflurane, Child Neglect
Keywords: Sevoflurane, Children, Electroencephalogram
Study type: Observational
Recruitment status: Recruiting
Enrolment: 280 participants (estimated)
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
Study start: 4 Sep 2024 (actual)
Primary completion: Sep 2026 (estimated)
Study completion: Sep 2026 (estimated)
First posted: 30 Aug 2024 (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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 14

Arm	Type	Receives
0-3 months	–	–EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
3-6 months	–	–EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
6-9 months	–	–EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
9-12 months	–	–EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
1-1.5 years	–	–EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
1.5-2 years	–	–EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
2-2.5 years	–	–EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
2.5-3 years	–	–EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
3-3.5 years	–	–EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
3.5-4 years	–	–EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
4-4.5 years	–	–EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
4.5-5 years	–	–EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
5-5.5 years	–	–EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
5.5-6 years	–	–EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.

Who may qualify

Ages: 1 day to 6 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child
Study population: The study population met the above inclusion criteria.

Key inclusion criteria (4 listed)

aged 1 days#6 years#;
with American Society of Anesthesiologists (ASA) physical status I or II#;
children requiring general anesthesia under sevoflurane;
parents or legal guardians of children who volunteered to participate in the trial; And signed the informed consent form.

Key exclusion criteria (4 listed)

Congenital malformation or other genetic conditions that are thought to affect brain development ;
History of severe heart, brain, liver, kidney and metabolic diseases ;
Premature infants (≤32 weeks);
Upper respiratory tract infection in the last two weeks.

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

Time-frequency characteristics of electroencephalogram (EEG)
Time frame: during sevoflurane general anesthesia (including anesthesia induction, maintenance and recovery)
Time-frequency characteristics of electroencephalogram (EEG) in children of different ages during sevoflurane general anesthesia (including anesthesia induction, maintenance and recovery) .

5 secondary outcomes

Modified observer's assessment of alertness#sedation#MOAA/S#scale
Time frame: during sevoflurane general anesthesia (including anesthesia induction, maintenance and recovery)
Recovery time
Time frame: Within up to 30 minutes after operation
Pediatric anesthesia emergence delirium
Time frame: Within up to 30 minutes after operation
The Face, Legs, Activity, Cry, Consolability Scale (FLACC)
Time frame: Within up to 30 minutes after operation
PHBQ-AS
Time frame: 3 days after operation

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.

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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.

Huacheng Liu contact

Yuhang Cai contact

Huacheng Liu principal investigator

Second Affiliated Hospital of Wenzhou Medical University

Yuhang Cai principal investigator

Second Affiliated Hospital of Wenzhou Medical University

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 Electroencephalography and Sevoflurane, run by Second Affiliated Hospital of Wenzhou Medical 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 7 Feb 2025. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Huacheng Liu (13957770577, huachengliu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time-frequency characteristics of electroencephalogram (EEG) (time frame: during sevoflurane general anesthesia (including anesthesia induction, maintenance and recovery)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06580028.

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 7 Feb 2025.