N\A
Conditions
Interventions
Experimental Group:Remazolam besylate for intravenous infusion
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. >= 65 years old; 2. Patients undergoing elective surgery other than general anesthesia, including nerve block anesthesia and spinal anesthesia; 3. ASA score is I-III; 4. BMI 18 kg/m2 to 30kg/m2; 5. Clearly understand and voluntarily participate in the research, and sign the informed consent form by myself.
Exclusion criteria
Exclusion criteria: 1. Patients who are going to undergo general anesthesia and endotracheal intubation (including laryngeal mask); 2. Acute heart failure; unstable angina; myocardial infarction within 6 months before screening; resting ECG heart rate = 450ms, female >= 470ms; 3. Patients with severe respiratory disease (obstructive sleep apnea syndrome, acute respiratory infection, acute exacerbation of chronic obstructive pulmonary disease, uncontrolled asthma, etc.); 4. Those who suffer from mental system diseases (schizophrenia, mania, bipolar disorder, insanity, etc.) and long-term use of psychotropic drugs and cognitive dysfunction; 5. Patients who are judged to be difficult to manage the respiratory tract (modified Markov score is grade IV); 6. Anemia or thrombocytopenia: Hb=2.5xULN, TBIL>=1.5xULN; 8. Abnormal renal function: urea or urea nitrogen >= 1.5xULN, serum creatinine is greater than the upper limit of normal; 9. A history of drug abuse, drug abuse, and alcohol abuse within 2 years prior to the start of the screening period. Alcohol abuse is an average of more than 2 units of alcohol per day (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine) ); 10. Patients who have not received regular antihypertensive treatment or have poor blood pressure control (sitting systolic blood pressure >=160 mmHg or =100 mmHg during screening); 11. Taking benzodiazepines and/or opioids every day for one month or intermittently for the past three months; 12. Those who are allergic to or have contraindications to benzodiazepines, opioids, propofol and other drugs and their drug components; 13. Participated in any clinical trial as a subject within the past 3 months; 14. The researchers believe that patients should not participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sedation success rate;Incidence of changes in cognitive function within one week after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sedation induction time;Calm recovery time;Incidence of delirium after waking up;Incidence of sedative hypotension; Incidence of sedative hypotension requiring treatment;The incidence of respiratory depression during sedation;Sleep rhythm within one week after surgery;Patient satisfaction;Patient anxiety; | — |
Countries
China
Contacts
Public ContactLi Yize
Tianjin Medical University General Hospital
Outcome results
None listed