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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| propofol | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From baseline (awake) through loss of responsiveness to recovery of responsiveness |
| EEG functional connectivity | EEG functional connectivity assessed by high-density EEG | From baseline (awake) through loss of responsiveness to recovery of responsiveness |
| Measure | Description | Time Frame |
|---|---|---|
| heart rate | Perioperative | |
| Blood pressure | Perioperative | |
| Oxygen Saturation |
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Inclusion Criteria:
Exclusion Criteria:
Subjects meeting any one of the following items will be excluded from this study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoge Liu | Contact | 021-64175590 | 18516534948@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200032 | China |
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.
Available starting from 1 year after study completion, and will be kept available for at least 5 years thereafter.
Only qualified researchers conducting independent academic research may access the de-identified IPD and supporting study documents, including study protocol, statistical analysis plan, and clinical research raw data. Access can be requested by submitting a formal research application to the corresponding author via official email, and access will be granted after formal review and approval.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form: Study Protocol V1.0 Mar20 2026 | Mar 20, 2026 | Jun 3, 2026 | Prot_SAP_ICF_000.pdf |
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form: ICF V1.0 Mar20 2026 | Mar 20, 2026 | Jun 3, 2026 | Prot_SAP_ICF_001.pdf |
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form: IRB Approval Letter No.2604-Exp427 | Apr 27, 2026 | Jun 3, 2026 | Prot_SAP_ICF_002.pdf |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| C000629870 | Esketamine |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Dexmeditomidine | Drug | 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. |
|
| Esketamine | Drug | 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. |
|
| Perioperative |
| Time to loss of responsiveness after study drug initiation | From start of study drug infusion until loss of responsiveness |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |