Status:
COMPLETED
A Study of Remimazolam Tosilate for Sedation in the Upper Gastrointestinal Endoscopy
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Sedation in the Upper Gastrointestinal Endoscopy
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 Upper Gastrointestinal Endoscopy
Eligibility Criteria
Inclusion
- patients or their guardians are able to provide a written informed consent
- participants undergo upper gastrointestinal endoscopy
- ≥18 years old, male or female
- 18 kg/m2≤bmi≤30kg/m2
Exclusion
- Subjects to be intubated (including laryngeal mask placement);
- Complex endoscopic diagnosis and treatment operations are required;
- Severe cardiovascular disease within 6 months prior to signing the ICF;
- Heart rate \< 50 beats/min during screening period;
- Subjects with poor blood pressure control during screening;
- Severe arrhythmias or heart disease; the circulatory system is unstable;
- Subjects with a history of severe cardiovascular disease, or cerebrovascular disease, or neurological disease, or mental illness
- Subjects with a history of drug abuse;
- Abnormal values of the laboratory examination;
- Allergic to relevant drugs ingredient or component;
- Pregnant or nursing women;
- Subjects who has participated in clinical trials of other interventions recently;
- Other conditions deemed unsuitable to be included.
Key Trial Info
Start Date :
December 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2023
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT06169995
Start Date
December 11 2023
End Date
December 16 2023
Last Update
December 29 2023
Active Locations (2)
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1
The Affiliated Hospital Of Guizhou Medical University
Guiyang, Guizhou, China, 550000
2
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610072