The Effects of Different Anesthetics on the Brain's Neural Networks

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anesthesia; Electroencephalogram (EEG)
• Intervention / Treatment: Drug: propofol; Drug: Dexmeditomidine; Drug: Esketamine

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Xiaoge Liu; Phone Number: 021-64175590; Email: 18516534948@163.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Fudan University Shanghai Cancer Center
      • Contact: Jun Zhang; Phone Number: +86 13817153025; Email: snapzhang@aliyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: propofol group; 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.	Drug: propofol; 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.
Experimental: Dexmedetomidine group; 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.	Drug: Dexmeditomidine; 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.
Experimental: Esketamine group; 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.	Drug: Esketamine; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Time Frame
Blood pressure	Perioperative
heart rate	Perioperative
Oxygen Saturation	Perioperative
Time to loss of responsiveness after study drug initiation	From start of study drug infusion until loss of responsiveness

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Estimated): June 9, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): September 10, 2026

Study Registration Dates

• First Submitted: May 14, 2026
• First Submitted That Met QC Criteria: June 8, 2026
• First Posted (Actual): June 12, 2026

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: anesthesia; EEG; loss of responsiveness
• Additional Relevant MeSH Terms: Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Phenols; Benzene Derivatives; Esketamine; Propofol
• Other Study ID Numbers: 2026-203-5055

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Available starting from 1 year after study completion, and will be kept available for at least 5 years thereafter.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No