Sedation
Conditions
Brief summary
A multicenter, randomized, single-blind, active controlled, parallel group study comparing remimazolam tosilate to propofol in patients undergoing bronchoscopy.
Interventions
Intravenous injection at a dose of 0.3mg/kg for sedation induction and continuous intravenous infusion at an initiative dose of 1 mg/kg/h for sedation maintenance.
DRUGPropofol
Intravenous injection at a dose of 1.5\ 2.5mg/kg for sedation induction and continuous intravenous infusion at the dose of 0\ 12 mg/kg/h for sedation maintenance
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. 18\ 80 years, female or male 2. Patients scheduled for an bronchoscopy procedure 3. 18 kg/m2\<BMI\<30kg/m2 4. Patients understand clearly and participate in the study voluntarily, and sign the informed consent
Exclusion criteria
1. Patients scheduled for emergency surgery 2. Patients with a history of drug abuse and / or alcohol abuse 2 years prior to the screening period 3. One or more of the laboratory findings fall out of the limitations for this study(platelet,hemoglobin,aspartate aminotransferase,etc.); 4. Pregnant women or those in lactation period 5. Allergic to drugs used in the study 6. Patients have participated in other clinical trial within the 3 months prior to randomization 7. Any patient judged by the Principal Investigator (PI) or Sub-Investigator to be inappropriate for the subject for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage (%) of participants who experienced successful sedation in undergoing bronchoscopy in each group | From the onset of administration of the study drug to removal of bronchoscope on Day 1 of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Time from start of investigational medicinal product administration to loss of consciousness | From the onset of administration of the study drug to unconsciousness on Day 1 of treatment |
| Time from stop of investigational medicinal product to MOAA/S Score=5 | From the last dose of study drug until the patient has recovered to fully alert on Day 1 of treatment |
| Time from stop of investigational medicinal product to Aldrete Score≥9 | From the end of administration of the study drug until the patient reaches the modified Aldrete's system score of ≥9 points on Day 1 of treatment |
Countries
China
Outcome results
None listed