General AnestheticNCT05210764
General Anesthetics-related Changes in Prefrontal EEG During Pediatric Surgical Anesthesia
An observational study of General Anesthetic and Electroencephalogram, run by Peking University First Hospital at 1 site in China.
Trial summary
The change profiles of indices derived from pEEG such as phase-amplitude coupling and bicoherence based on individual general anesthetics in children have not been examined in previous literature. Read more about this study
- Who is it for?
- Ages 1 minute to 18 years
- Conditions the study is for
- General Anesthetic, Electroencephalogram
- What is being tested?
- propofol, sevoflurane and S-ketamine
- How many people
- 366 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to Aug 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 minute to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: patients aged 0-18 years, American Society of Anesthesiologists Physical Status I-II, scheduled for elective surgery in Peking University First Hospital
Who may be able to join
- patients aged 0-18 years, American Society of Anesthesiologists Physical Status I-II, scheduled for elective surgery in Peking University First Hospital.
Who cannot join
- Preterm patients;
- Height and weight not within the standard ranges for respective ages;
- Surgery for head or heart;
- Patients with muscular, neurologic or psychiatric diseases;
- Patients with Congenital anomaly or hereditary diseases;
- Patients with medication abuse;
Show all 9Show fewer
- Allergy to medication including propofol, sevoflurane, and ketamine;
- Allergy to beans;
- Refusal to participate the study by guardians.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing
Lin-Lin no Song, MD, 86-010-83575138, songlinlinlynkia@163.com
About this study
The change profiles of indices derived from pEEG such as phase-amplitude coupling and bicoherence based on individual general anesthetics in children have not been examined in previous literature. Whether those indices have the abilities to predict individual drug-related anesthesia depth in children need to be explored.
Read the detailed description
The need to maintain a proper depth of general anesthesia during pediatric surgery is an important aspect of anesthesiology. An inappropriate anesthesia depth increases the risk of intraoperative awareness or delay in recovery in children undergoing surgery. Current modalities for anesthesia depth monitoring showed limited accuracy in children. The electroencephalogram (EEG) can be analyzed in its raw form for characteristic drug-induced patterns of change or summarized using mathematical parameters as a processed electroencephalogram (pEEG). The change profiles of indices derived from pEEG such as phase-amplitude coupling and bicoherence based on individual general anesthetics in children have not been examined in previous literature. Whether those indices have the abilities to predict individual drug-related anesthesia depth in children need to be explored.
- Conditions
- General Anesthetic, Electroencephalogram
- Being tested
- propofol, sevoflurane, S-ketamine
- Keywords
- general anesthetic, electroencephalogram
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDrug
Also called Propofol anesthesia group
General anesthesia is induced and maintained mainly with propofol.
sevofluraneDrug
Also called Sevoflurane anesthesia group
General anesthesia is induced and maintained mainly with sevoflurane.
S-ketamineDrug
Also called S-ketamine anesthesia group
General anesthesia is induced mainly with S-ketamine and maintained mainly with propofol.
| Study group | Role | What they receive |
|---|---|---|
| propofol | General anesthesia is induced and maintained mainly with propofol. Receives: Drug: propofol | |
| sevoflurane | General anesthesia is induced and maintained mainly with sevoflurane. Receives: Drug: sevoflurane | |
| ketamine | General anesthesia is induced mainly with S-ketamine and maintained mainly with propofol. Receives: Drug: S-ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
phase-amplitude coupling
phase-amplitude coupling
Measured: induction, maintenance, and recovery of anesthesia
bicoherence
bicoherence
Measured: induction and maintenance, and recovery of anesthesia
spectral analysis
spectral analysis
Measured: induction and maintenance, and recovery of anesthesia
entropy indices
entropy indices
Measured: induction and maintenance, and recovery of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start1 Jun 2022
- Primary completionMar 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for General AnestheticStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe 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
- 366 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong-Xin Wang, Peking University First Hospital
- Investigators
- Dong-Xin Wang, MD, PhD, Study director, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05210764
- Sponsor's protocol ID
- 2022-01-08
- Status last verified
- Jul 2025
- First submitted
- 9 Jan 2022
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang Y, Liang ZH, Wang X, Zhang N, Zhu HT, Wang DX, Guo XY, Li XL, Song LL. Age-Dependent Entropic Features During Propofol Anesthesia in Developing Brain. Anesth Analg. 2026 Apr 1;142(4):769-781. doi: 10.1213/ANE.0000000000007608. Epub 2025 Jul 10.
PubMed 40638527
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- General Anesthetics-related Changes in Prefrontal EEG During Pediatric Surgical Anesthesia
- ClinicalTrials.gov ID
- NCT05210764
- Acronym / sponsor ID
- 2022-01-08
- Conditions
- General Anesthetic, Electroencephalogram
- Keywords
- general anesthetic, electroencephalogram
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 366 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 27 Jan 2022 (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 change profiles of indices derived from pEEG such as phase-amplitude coupling and bicoherence based on individual general anesthetics in children have not been examined in previous literature. Whether those indices have the abilities to predict individual drug-related anesthesia depth in children need to be explored.
Detailed description
The need to maintain a proper depth of general anesthesia during pediatric surgery is an important aspect of anesthesiology. An inappropriate anesthesia depth increases the risk of intraoperative awareness or delay in recovery in children undergoing surgery. Current modalities for anesthesia depth monitoring showed limited accuracy in children. The electroencephalogram (EEG) can be analyzed in its raw form for characteristic drug-induced patterns of change or summarized using mathematical parameters as a processed electroencephalogram (pEEG). The change profiles of indices derived from pEEG such as phase-amplitude coupling and bicoherence based on individual general anesthetics in children have not been examined in previous literature. Whether those indices have the abilities to predict individual drug-related anesthesia depth in children need to be explored.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| propofol | – | Drug: propofolGeneral anesthesia is induced and maintained mainly with propofol. |
| sevoflurane | – | Drug: sevofluraneGeneral anesthesia is induced and maintained mainly with sevoflurane. |
| ketamine | – | Drug: S-ketamineGeneral anesthesia is induced mainly with S-ketamine and maintained mainly with propofol. |
Who may qualify
- Ages
- 1 minute to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- patients aged 0-18 years, American Society of Anesthesiologists Physical Status I-II, scheduled for elective surgery in Peking University First Hospital
Key inclusion criteria (1 listed)
- patients aged 0-18 years, American Society of Anesthesiologists Physical Status I-II, scheduled for elective surgery in Peking University First Hospital.
Key exclusion criteria (9 listed)
- Preterm patients;
- Height and weight not within the standard ranges for respective ages;
- Surgery for head or heart;
- Patients with muscular, neurologic or psychiatric diseases;
- Patients with Congenital anomaly or hereditary diseases;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| propofolAlso: Propofol anesthesia groupGeneral anesthesia is induced and maintained mainly with propofol. | Drug | propofol |
| sevofluraneAlso: Sevoflurane anesthesia groupGeneral anesthesia is induced and maintained mainly with sevoflurane. | Drug | sevoflurane |
| S-ketamineAlso: S-ketamine anesthesia groupGeneral anesthesia is induced mainly with S-ketamine and maintained mainly with propofol. | Drug | ketamine |
Primary outcome
phase-amplitude coupling
Time frame: induction, maintenance, and recovery of anesthesia
phase-amplitude coupling
bicoherence
Time frame: induction and maintenance, and recovery of anesthesia
bicoherence
spectral analysis
Time frame: induction and maintenance, and recovery of anesthesia
spectral analysis
entropy indices
Time frame: induction and maintenance, and recovery of anesthesia
entropy indices
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 31 Jul 2025.
- Derived from this study: PubMed 40638527Zhang Y, Liang ZH, Wang X, Zhang N, Zhu HT, Wang DX, Guo XY, Li XL, Song LL. Age-Dependent Entropic Features During Propofol Anesthesia in Developing Brain. Anesth Analg. 2026 Apr 1;142(4):769-781. doi: 10.1213/ANE.0000000000007608. Epub 2025 Jul 10.
- Individual participant dataSharing planned: No
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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.
Dong-Xin Wang, MD, PhD study director
Peking University First Hospital
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 General Anesthetic and Electroencephalogram, run by Peking University First Hospital 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 1 inclusion and 9 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 31 Jul 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 Linlin Song, MD (86-13501309217, songlinlinlynkia@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
phase-amplitude coupling (time frame: induction, maintenance, and recovery of anesthesia). The study lists 4 primary outcomes in all. 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 NCT05210764, which also lists 1 linked publication.
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 31 Jul 2025.