Consciousness
Conditions
Interventions
Gold Standard:1. Anesthesia Induction and Emergence Phases
Patient sedation levels were assessed by two independent, senior anesthesiologists (with at least 3 years of experience as attending physicia
Index test:Evaluation of Anesthesia Depth Index (NSI Index) of a Novel Anesthesia Depth Monitor
Sponsors
West China hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 to 65 years old (inclusive), undergoing elective surgery under general anesthesia, excluding cardiac surgery, neurosurgery and obstetric surgery; 2. The expected anesthesia time (defined as the period from anesthesia induction to the discontinuation of the anesthetic drug) is greater than 60 minutes; 3.ASA I-III grade; 4. The body mass index (BMI) is 18.5-28kg/ m^2. 5. One must have given informed consent to this trial before the trial and voluntarily signed a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Have a history of mental and neurological disorders such as autism, attention deficit hyperactivity disorder, epilepsy, cerebral infarction, etc. 2. Previous history of craniocerebral surgery; 3. Those with high risk of reflux and aspiration that require rapid sequential induction; 4. There has been a history of using opioid drugs, sedatives or other psychotropic drugs within the past three months; 5. Those with a history of alcohol abuse within the three months prior to screening, where alcohol abuse refers to an average daily consumption of more than 2 units of alcohol (1 unit =360mL), beer, 45mL of 40% alcohol liquor, or 150 ml of wine. 6. Hearing impairment, language communication impairment, physical movement impairment or intellectual disability; 7. Limitations in the adhesion of electroencephalogram (EEG) sensors, such as conflicts between the EEG monitoring area and the surgical disinfection area, etc. 8. Those who are known to be allergic to the components of the anesthetic drugs to be used; 9. People susceptible to malignant hyperthermia; 10. Pregnant and lactating women; 11. Those who are judged by the researchers as not suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Agreement Rate between the Investigational Device (NSI Index) and the Reference Standard; | — |
Secondary
| Measure | Time frame |
|---|---|
| AUC of NSI Index for Consciousness State Discrimination;Agreement on Consciousness State between NSI Index and Reference Standard (Kappa Statistic);Incidence of Intraoperative Awareness;Anesthesiologist Rating of Satisfaction Regarding Device Performance;Compare the agreement rate between BIS values and MOAA/S scores with that between the NSI index and MOAA/S scores.; | — |
Countries
China
Contacts
Public ContactJun Zeng
West China hospital, Sichuan University
Outcome results
None listed