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Not yet recruiting NCT07644663

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

Phase IV Interventional Electroencephalogram (EEG) Anesthesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: propofol, Dexmeditomidine, Esketamine.
Who it may be relevant to
Registry conditions: Electroencephalogram (EEG), Anesthesia. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Propofol, Dexmedetomidine, and Esketamine-Induced Unresponsive States: Alterations in Information Integration and Brain Networks

Overview

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.

Interventions

  • 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.
  • 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.
  • 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.

Primary outcome measures

  • Permutation cross mutual information (PCMI) and PCMI-based brain networks [Time frame: From baseline (awake) through loss of responsiveness to recovery of responsiveness]
  • EEG functional connectivity [Time frame: From baseline (awake) through loss of responsiveness to recovery of responsiveness]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Diagnostic

Study locations

China · 1 center
  • Fudan University Shanghai Cancer Center — Shanghai

Identifiers

NCT: NCT07644663 · 2026-203-5055

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗