Elective surgery
Conditions
Interventions
Intervention Group:I.V. Remazolam toluenesulfonate 0.05mg/kg
Control Group:I.V. Eomidate 0.05mg/kg
Sponsors
Department of Anesthesiology, Xuanwu Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
61 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 65-85 years old, regardless of gender; 2. The patients underwent elective surgery (endotracheal intubation / laryngeal mask airway mechanical ventilation); 3. The ASA score was grade I ~ III (Annex 4); 4. 18 kg/m2<BMI<30kg/m2; 5. They clearly understood and voluntarily participated in the study, and their informed consent was signed by themselves.
Exclusion criteria
Exclusion criteria: 1. Emergency surgery; hypovolemia, shock or coma; 2. Besides general intravenous anesthesia, other anesthesia methods should be combined, such as inhalation anesthesia, epidural anesthesia, subarachnoid anesthesia, etc; 3. Infectious heart disease such as myocarditis or endocarditis; 4. We plan to perform cardiopulmonary bypass; plan heart, liver, kidney transplantation; plan the type of operation may affect the collection of BIS index; 5. Coagulation function was abnormal (Pt or INR >= 1.5 x ULN, APTT >= 1.5 x ULN); 6. Anemia or thrombocytopenia, Hb = 2.5 x ULN, TBIL >= 1.5 x ULN; 8. Renal function was abnormal, urea or urea nitrogen >= 1.5 x ULN, and serum creatinine was higher than the upper limit of normal value; 9. Acute heart failure; unstable angina pectoris; myocardial infarction within 6 months before screening; resting ECG heart rate = 450 ms, female >= 470 MS; 10. Patients with hypertension whose blood pressure was not controlled satisfactorily (SBP >= 160 mmHg and / or DBP >= 100 mmHg during screening period); 11. During the screening period, the sitting systolic blood pressure was <= 90 mmHg; 12. 1 mmol / L in the screening period; 13. There was a history of drug abuse and / or alcohol abuse within 2 years before screening, i.e. drinking more than 2 units of alcohol per day (1 unit = 360 ml beer or 45 ml liquor with 40% alcohol content or 150 ml wine); 14. Patients with mental system diseases (schizophrenia, mania, bipolar disorder, mental disorder, etc.) and long-term use of psychotropic drugs and cognitive dysfunction; 15. Allergic or contraindicated to benzodiazepines, opioids, etomidate, muscle relaxants and their components; 16. Patients with respiratory tract management difficulties (e.g. modified Markovian score grade IV); 17. Participated in other drug clinical trials as subjects in recent 3 months; 18. Other situations in which the researchers consider it inappropriate to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of anesthesia induction; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of delirium in postoperative recovery period;The incidence of delirium within 3 days after operation;Incidence of adverse reactions;D50 of remazolam toluenesulfonate for induction of general anesthesia in elderly patients;BIS value (bis50) of remazolam toluenesulfonate used in inducing half of elderly patients to fall asleep under general anesthesia;IL-6; | — |
Countries
China
Contacts
Public ContactWang Tianlong
Xuanwu Hospital Capital Medical University
Outcome results
None listed