Anesthesia, Electroencephalogram (EEG)
Conditions
Keywords
EEG, anesthesia, loss of responsiveness
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.
Interventions
DRUGpropofol
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.
DRUGDexmeditomidine
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.
DRUGEsketamine
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.
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Permutation cross mutual information (PCMI) and PCMI-based brain networks | From baseline (awake) through loss of responsiveness to recovery of responsiveness | EEG power spectrum \[broadband (0.1-45 Hz) and sub-band frequencies\] assessed by high-density EEG |
| EEG functional connectivity | From baseline (awake) through loss of responsiveness to recovery of responsiveness | EEG functional connectivity assessed by high-density EEG |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Contacts
CONTACTXiaoge Liu
Outcome results
None listed