Electroencephalogram (EEG)Phase 4NCT07644663
The Effects of Different Anesthetics on the Brain's Neural Networks
A Phase 4 study testing propofol, Dexmeditomidine and Esketamine in people with Electroencephalogram (EEG) and Anesthesia, run by Fudan University at 1 site in China.
Trial summary
This study aims to analyze the electroencephalographic power spectrum and connectivity during unresponsive states induced by propofol, esketamine and dexmedetomidine, respectively. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Electroencephalogram (EEG), Anesthesia
- What is being tested?
- propofol, Dexmeditomidine and Esketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 9 Jun 2026to 10 Sep 2026
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective non-cardiac surgery;
- American Society of Anesthesiologists (ASA) physical status classification I-II;
- Aged 18 to 65 years, regardless of gender;
- Body mass index (BMI) greater than 18 kg/m² and no more than 31 kg/m²;
- Written informed consent voluntarily signed by the patient or legal authorized representative for participation in this study.
Who cannot join
- Subjects meeting any one of the following items will be excluded from this study:
- Presence of severe cardiovascular diseases or hepatic and renal insufficiency;
- Hearing impairment;
- History of psychiatric disorders or communication disorders;
- Anticipated difficult airway;
- Pregnant or lactating women;
- History of allergic reaction or contraindication to any of the three anesthetic drugs used in this trial;
- Participation in other clinical trials within the past 3 months.
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
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Jun Zhang, +86 13817153025, snapzhang@aliyun.com
About this study
Official title: Propofol, Dexmedetomidine, and Esketamine-Induced Unresponsive States: Alterations in Information Integration and Brain Networks
This study aims to analyze the electroencephalographic power spectrum and connectivity during unresponsive states induced by propofol, esketamine and dexmedetomidine, respectively. It intends to explore the macro neural mechanisms underlying anesthetic unresponsiveness, so as to further elucidate the mechanisms by which anesthetics induce loss and recovery of consciousness. In addition, this study will identify neural biomarkers under general anesthesia for monitoring patients' actual intraoperative consciousness status. The findings will facilitate the development of monitoring indicators and devices reflecting intraoperative consciousness during general anesthesia, enabling more accurate assessment of patients' intraoperative consciousness status.
- Conditions
- Electroencephalogram (EEG), Anesthesia
- Being tested
- propofol, Dexmeditomidine, Esketamine
- Keywords
- EEG, anesthesia, loss of responsiveness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDrug
All patients in this arm receive Propofol at a concentration of 10 mg/mL, administered via infusion at a dose of 1 mg/kg and completed within 5 minutes.
DexmeditomidineDrug
All subjects in this arm receive Dexmedetomidine with a prepared concentration of 10 μg/mL. A loading dose of 1.0 μg/kg is administered by infusion and completed within 10 minutes.
EsketamineDrug
All subjects in this arm are given Esketamine at a prepared concentration of 5 mg/mL, infused at a dose of 0.5 mg/kg and completed within 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| propofol group | Experimental | All patients in this arm receive Propofol at a concentration of 10 mg/mL, administered via infusion at a dose of 1 mg/kg and completed within 5 minutes. Receives: Drug: propofol |
| Dexmedetomidine group | Experimental | All subjects in this arm receive Dexmedetomidine with a prepared concentration of 10 μg/mL. A loading dose of 1.0 μg/kg is administered by infusion and completed within 10 minutes. Receives: Drug: Dexmeditomidine |
| Esketamine group | Experimental | All subjects in this arm are given Esketamine at a prepared concentration of 5 mg/mL, infused at a dose of 0.5 mg/kg and completed within 10 minutes. Receives: Drug: Esketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Permutation cross mutual information (PCMI) and PCMI-based brain networks
EEG power spectrum [broadband (0.1-45 Hz) and sub-band frequencies] assessed by high-density EEG
Measured: From baseline (awake) through loss of responsiveness to recovery of responsiveness
EEG functional connectivity
EEG functional connectivity assessed by high-density EEG
Measured: From baseline (awake) through loss of responsiveness to recovery of responsiveness
Secondary outcomes (4)
heart rate
Measured: Perioperative
Blood pressure
Measured: Perioperative
Oxygen Saturation
Measured: Perioperative
Time to loss of responsiveness after study drug initiation
Measured: From start of study drug infusion until loss of responsiveness
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start9 Jun 2026 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion10 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electroencephalogram (EEG)Studies of the same condition, open and under way.
- More trials run by Fudan 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Zhang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07644663
- Sponsor's protocol ID
- 2026-203-5055
- Status last verified
- Jun 2026
- First submitted
- 14 May 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data including demographic characteristics, baseline clinical information, perioperative vital sign data, anesthesia induction and recovery related data, EEG analysis results, and adverse event records will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propofol, Dexmedetomidine, and Esketamine-Induced Unresponsive States: Alterations in Information Integration and Brain Networks
- ClinicalTrials.gov ID
- NCT07644663
- Acronym / sponsor ID
- 2026-203-5055
- Conditions
- Electroencephalogram (EEG), Anesthesia
- Keywords
- EEG, anesthesia, loss of responsiveness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 9 Jun 2026 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 10 Sep 2026 (estimated)
- First posted
- 12 Jun 2026 (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.
This study aims to analyze the electroencephalographic power spectrum and connectivity during unresponsive states induced by propofol, esketamine and dexmedetomidine, respectively. It intends to explore the macro neural mechanisms underlying anesthetic unresponsiveness, so as to further elucidate the mechanisms by which anesthetics induce loss and recovery of consciousness. In addition, this study will identify neural biomarkers under general anesthesia for monitoring patients' actual intraoperative consciousness status. The findings will facilitate the development of monitoring indicators and devices reflecting intraoperative consciousness during general anesthesia, enabling more accurate assessment of patients' intraoperative consciousness status.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| propofol group | Experimental | Drug: propofolAll patients in this arm receive Propofol at a concentration of 10 mg/mL, administered via infusion at a dose of 1 mg/kg and completed within 5 minutes. |
| Dexmedetomidine group | Experimental | Drug: DexmeditomidineAll subjects in this arm receive Dexmedetomidine with a prepared concentration of 10 μg/mL. A loading dose of 1.0 μg/kg is administered by infusion and completed within 10 minutes. |
| Esketamine group | Experimental | Drug: EsketamineAll subjects in this arm are given Esketamine at a prepared concentration of 5 mg/mL, infused at a dose of 0.5 mg/kg and completed within 10 minutes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients scheduled for elective non-cardiac surgery;
- American Society of Anesthesiologists (ASA) physical status classification I-II;
- Aged 18 to 65 years, regardless of gender;
- Body mass index (BMI) greater than 18 kg/m² and no more than 31 kg/m²;
- Written informed consent voluntarily signed by the patient or legal authorized representative for participation in this study.
Key exclusion criteria (8 listed)
- Presence of severe cardiovascular diseases or hepatic and renal insufficiency;
- Hearing impairment;
- History of psychiatric disorders or communication disorders;
- Anticipated difficult airway;
- Pregnant or lactating women;
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 |
|---|---|---|
| propofolAll patients in this arm receive Propofol at a concentration of 10 mg/mL, administered via infusion at a dose of 1 mg/kg and completed within 5 minutes. | Drug | propofol group |
| DexmeditomidineAll subjects in this arm receive Dexmedetomidine with a prepared concentration of 10 μg/mL. A loading dose of 1.0 μg/kg is administered by infusion and completed within 10 minutes. | Drug | Dexmedetomidine group |
| EsketamineAll subjects in this arm are given Esketamine at a prepared concentration of 5 mg/mL, infused at a dose of 0.5 mg/kg and completed within 10 minutes. | Drug | Esketamine group |
Primary outcome
Permutation cross mutual information (PCMI) and PCMI-based brain networks
Time frame: From baseline (awake) through loss of responsiveness to recovery of responsiveness
EEG power spectrum [broadband (0.1-45 Hz) and sub-band frequencies] assessed by high-density EEG
EEG functional connectivity
Time frame: From baseline (awake) through loss of responsiveness to recovery of responsiveness
EEG functional connectivity assessed by high-density EEG
4 secondary outcomes
heart rate
Time frame: Perioperative
Blood pressure
Time frame: Perioperative
Oxygen Saturation
Time frame: Perioperative
Time to loss of responsiveness after study drug initiation
Time frame: From start of study drug infusion until loss of responsiveness
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 12 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data including demographic characteristics, baseline clinical information, perioperative vital sign data, anesthesia induction and recovery related data, EEG analysis results, and adverse event records will be shared.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing propofol, Dexmeditomidine and Esketamine in people with Electroencephalogram (EEG) and Anesthesia, run by Fudan 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 5 inclusion and 8 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: opening soon, as of the sponsor's last update on 12 Jun 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Xiaoge Liu (021-64175590, 18516534948@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Permutation cross mutual information (PCMI) and PCMI-based brain networks (time frame: From baseline (awake) through loss of responsiveness to recovery of responsiveness). The study lists 2 primary outcomes in all. 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 Jun 2026.