Sedation in Non-intubated Diagnostic and Therapeutic Procedures
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in non-intubated diagnostic and therapeutic procedures
Interventions
Initial loading dose of 5mg, with additional doses of 2.5mg as necessary
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years old, male or female 2. Intending to undergo routine gastroscopy or colonoscopy 3. ASA (American Society of Anesthesiologists) I to III 4. 18 kg/m2≤BMI (Body Mass Index)≤30kg/m2 5. Signed informed consent
Exclusion criteria
1. Subjects need to be tracheal intubation 2. Subjects need to be complicated endoscopic diagnostic and therapeutic procedures 3. Subjects who have had severe cardiovascular diseases or severe arrhythmias within 6 months prior to signing the ICF 4. Heart rate \<50 beats/min during the screening period 5. Poor blood pressure control during the screening period 6. Subjects with severe respiratory diseases 7. Subjects with respiratory management difficulties (Modified Mallampati grade IV) 8. Subjects with a history of mental illness (schizophrenia, mania, bipolar disorder, psychosis, etc.), long-term use of psychotropic drugs, and cognitive impairment 9. A history of drug abuse or addiction within 2 years prior to signing the ICF 10. Pregnant women or those in lactation period 11. Allergic to relevant drugs ingredient or component in the study 12. Currently participating in or planning to participate in other drug or device clinical trials during this study 13. Other conditions deemed unsuitable to be included
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of sedation success, Sedation success | day 1 | Rate of sedation success, Sedation success is defined as: 1) Completion of the entire non-intubated diagnostic and therapeutic procedure; 2) No need for additional rescue sedation; 3) During the sedation induction phase, the MOAA/S score should be ≤3 within 2 minutes after the end of the initial dose administration or after ≤2 additional administrations; 4) No more than 2 additional administrations in every 5-minute. |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects needing additional administration. | day 1 |
| One-time success rate of endoscope insertion during the diagnostic and therapeutic procedure. | day 1 |
| Rate of over-sedation. | day 1 |
| Sedation induction time | day 1 |
| Wake-up time. | day 1 |
| Number of additional administrations. | day 1 |
| Rate of sedation-related hypotension and rate of sedation-related hypotension needing treatment. | day 1 |
| Rate of respiratory depression during sedation. | day 1 |
| Investigator's Satisfaction with Sedation Assessment: The scoring range is from 0 to 10, where 0 represents dissatisfaction and 10 represents complete satisfaction. | day 1 |
| Participant's satisfaction with Sedation Assessment: The scoring range is from 0 to 10, where 0 represents dissatisfaction and 10 represents complete satisfaction. | day 1 |
| Time to discharge. | day 1 |
Countries
China
Contacts
Primary ContactQin Liu
Outcome results
None listed