Clinical trial NCT06216444: A Study of Remimazolam Tosilate for Sedation in Non-intubated Diagnostic and Therapeutic Procedures
Official title: A Multi-center, Randomized, Double-blind Clinical Study to Evaluate the Efficacy and Safety of Remimazolam Tosilate (Ruibeining®) for Injection for Sedation in Non-intubated Diagnostic and Therapeutic Procedures
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Sedation in Non-intubated Diagnostic and Therapeutic Procedures
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-01-22
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Rate of sedation success, Sedation success
timeFrame: day 1
Secondary outcomes:
measure: Number of additional administrations.
timeFrame: day 1
measure: Percentage of subjects needing additional administration.
timeFrame: day 1
measure: One-time success rate of endoscope insertion during the diagnostic and therapeutic procedure.
timeFrame: day 1
measure: Rate of over-sedation.
timeFrame: day 1
measure: Sedation induction time
timeFrame: day 1
measure: Wake-up time.
timeFrame: day 1
measure: Time to discharge.
timeFrame: day 1
measure: Rate of sedation-related hypotension and rate of sedation-related hypotension needing treatment.
timeFrame: day 1
measure: Rate of respiratory depression during sedation.
timeFrame: day 1
measure: Investigator's Satisfaction with Sedation Assessment: The scoring range is from 0 to 10, where 0 represents dissatisfaction and 10 represents complete satisfaction.
timeFrame: day 1
measure: Participant's satisfaction with Sedation Assessment: The scoring range is from 0 to 10, where 0 represents dissatisfaction and 10 represents complete satisfaction.
timeFrame: day 1
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
References: