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

NCT07644663 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 2026-203-5055
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

EEG; anesthesia; loss of responsiveness

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• heart rate

  Perioperative

• Blood pressure

  Perioperative

• Oxygen Saturation

  Perioperative

• Time to loss of responsiveness after study drug initiation

  From start of study drug infusion until loss of responsiveness

Study Arms (3)

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.

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.

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.

Drug: Esketamine

Interventions

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.

propofol group

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.

Dexmedetomidine group

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.

Esketamine group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Interventions

Propofol; Esketamine

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Xiaoge Liu

CONTACT

021-64175590; 18516534948@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Anesthesiology Department, Fudan University Shanghai Cancer Center

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: June 12, 2026
• Study Start: June 9, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): September 10, 2026
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Available starting from 1 year after study completion, and will be kept available for at least 5 years thereafter.
• 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.

Locations

CN (1)