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

Phase 4Not Yet RecruitingNCT07644663

Fudan University120 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

120

Conditions

Electroencephalogram (EEG)Anesthesia

Interventions

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.

DexmeditomidineDRUG

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.

EsketamineDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

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

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

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

Central Contacts

Xiaoge Liu

CONTACT

021-64175590 18516534948@163.com

Data from ClinicalTrials.gov

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