Disease of skeletal motor system
Conditions
Interventions
Experimental group:Sedation of remazolam toluenesulfonate during intravenous surgery
Control group:Sedation during intravenous propofol surgery
Sponsors
The Central Hospital of Enshi Tujia and Miao Autonomous Prefesture
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 65 years; 2.Patients who underwent elective lower extremity or lower abdominal surgery and received subarachnoid anesthesia; 3.ASA classification I~II; 4.No serious cardiovascular and cerebrovascular diseases, normal liver and kidney functions, no anesthetic drug allergy or other special history.Patients with any of the following exclusion criteria were not included in the study; 5.Patients or their family members have a full understanding of the purpose and significance of the trial, voluntarily participate in the clinical trial, and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1.The patient's physical condition is difficult to evaluate the efficacy (such as severe central nervous system surgery or intracranial surgery); 2.Diabetic patients whose blood glucose was not satisfactorily controlled (fasting blood glucose >=11.1mmol/L during the screening period); 3.History of myocardial infarction and unstable angina within 6 months prior to screening period; 4.Patients with bradycardia (heart rate 1.5 times the upper limit of normal value, APTT > 1.5 times the upper limit of normal value), bleeding tendency (such as active gastrointestinal ulcer) or receiving thrombolytic or anticoagulant therapy; 8.Abnormal liver function, ALT and/or AST > 1.5 times the upper limit of normal; 9.Abnormal renal function, serum creatinine (Cr) and/or blood urea nitrogen (BUN) > 1.5 times the upper limit of normal; hemodialysis patients; 10.Allergic to the ingredient or component under test; 11.Participate in clinical trials of other drugs within 3 months; 12.Patients with myasthenia gravis, schizophrenia or severe depression; 13.Patients allergic to benzodiazepines.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of hypotension;Incidence of postoperative dizziness, nausea and vomiting; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sedation onset time;Sedative awakening time;Respiratory depression;Postoperative delirium;Hypertension;Tachycardia;Bradycardia;The injection pain; | — |
Countries
China
Contacts
Public ContactZhu Xianlin
The Central Hospital of Enshi Tujia and Miao Autonomous Prefesture
Outcome results
None listed