Status:
UNKNOWN
A Study of Remimazolam Tosilate for Sedation in Non-intubated Diagnostic and Therapeutic Procedures
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Sedation in Non-intubated Diagnostic and Therapeutic Procedures
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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
- Age ≥18 years old, male or female
- Intending to undergo routine gastroscopy or colonoscopy
- ASA (American Society of Anesthesiologists) I to III
- 18 kg/m2≤BMI (Body Mass Index)≤30kg/m2
- Signed informed consent
Exclusion
- Subjects need to be tracheal intubation
- Subjects need to be complicated endoscopic diagnostic and therapeutic procedures
- Subjects who have had severe cardiovascular diseases or severe arrhythmias within 6 months prior to signing the ICF
- Heart rate \<50 beats/min during the screening period
- Poor blood pressure control during the screening period
- Subjects with severe respiratory diseases
- Subjects with respiratory management difficulties (Modified Mallampati grade IV)
- Subjects with a history of mental illness (schizophrenia, mania, bipolar disorder, psychosis, etc.), long-term use of psychotropic drugs, and cognitive impairment
- A history of drug abuse or addiction within 2 years prior to signing the ICF
- Pregnant women or those in lactation period
- Allergic to relevant drugs ingredient or component in the study
- Currently participating in or planning to participate in other drug or device clinical trials during this study
- Other conditions deemed unsuitable to be included
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2024
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT06216444
Start Date
January 1 2024
End Date
March 1 2024
Last Update
January 22 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032