None listed
Conditions
Interventions
Gold Standard:The reference standard for sedation level: bispectral index (BIS)
The reference standard for analgesia level: surgical pleth index (SPI) and pupillary dilatation (PD).
Index test:The experimental indicators are wavelet index (WLi) and pain threshold index (PTI) obtained by anesthesia depth monitoring based on the EEG wavelet algorithm.
Sponsors
The Second Affiliated Hospital of Naval Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Adult patients (aged 18~75 years) undergoing non-cardiac elective surgeries under target-controlled infusion intravenous anesthesia with propofol-remifentanil in each center.; 2. The subject meets the American Society of Anesthesiologists physical health status classification: Class I - Class II 3. 18.5 kg/m² = BMI < 30 kg/m²; 4. After fully explaining the study and with the subject fully understanding, sign a written informed consent form; 5. The subject's surgical position requires the patient to be supine.
Exclusion criteria
Exclusion criteria: 1. Central nervous system diseases and mental disorders; 2. Taking sedative or antidepressant drugs; 3. Communication difficulties (e.g. language difficulties, severe visual or hearing impairments); 4. Severe cardiopulmonary and cerebrovascular diseases, pacemaker implantation, bradycardia, uncontrolled hypertension [SBP > 180 mmHg and/or DBP > 100 mmHg at rest]; 5. Disorders of ocular muscles, neuromuscular system or pain perception; 6. Allergic to the drugs in this trial, pregnant women, difficult airway; 7. Expected operation duration > 3 hours; 8. Actual operation duration > 3 hours; 9. Participated in other clinical studies within 3 months; 10. The researcher believes that the subject is not suitable for participating in this clinical study due to other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| intraclass correlation coefficient ;The area under the receiver operating characteristic curve (PTI/SPI/PD; | — |
Secondary
| Measure | Time frame |
|---|---|
| The average difference ;The standard deviation of difference ;The 95% Limits of Agreement;The proportion outside the consistency range ;sensitivity (PTI/SPI/PD);specificity (PTI/SPI/PD);The Youden Index (PTI/SPI/PD);The Prediction probabilities (PTI/SPI/PD) ;Pearson correlation coefficient (BIS/WLi); | — |
Countries
China
Contacts
Public ContactFu Hailong
The Second Affiliated Hospital of Naval Military Medical University
Outcome results
None listed