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

ConditionsElectroencephalogram (EEG)Anesthesia
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorFudan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

Presence of severe cardiovascular diseases or hepatic and renal insufficiency;

Hearing impairment;

History of psychiatric disorders or communication disorders;

Anticipated difficult airway;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: propofol groupExperimental treatment 1 intervention
Group B: Dexmedetomidine groupExperimental treatment 1 intervention
Group C: Esketamine groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
From baseline (awake) through loss of responsiveness to recovery of responsiveness
2

EEG functional connectivity

EEG functional connectivity assessed by high-density EEG

Time frame
From baseline (awake) through loss of responsiveness to recovery of responsiveness

Secondary outcomes

1

heart rate

Time frame
Perioperative
2

Blood pressure

Time frame
Perioperative
3

Oxygen Saturation

Time frame
Perioperative
4

Time to loss of responsiveness after study drug initiation

Time frame
From start of study drug infusion until loss of responsiveness

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: