A Study of Remimazolam Tosilate for Sedation in the Upper Gastrointestinal Endoscopy
NCT ID: NCT06169995
Last Updated: 2023-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
31 participants
INTERVENTIONAL
2023-12-11
2023-12-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Remimazolam Tosilate for Injection
Remimazolam Tosilate
bolus dose: 5mg，IV supplemental dose: 2.5mg，IV
Interventions
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Remimazolam Tosilate
bolus dose: 5mg，IV supplemental dose: 2.5mg，IV
Eligibility Criteria
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Inclusion Criteria
2. participants undergo upper gastrointestinal endoscopy
3. ≥18 years old, male or female
4. 18 kg/m2≤bmi≤30kg/m2
Exclusion Criteria
2. Complex endoscopic diagnosis and treatment operations are required;
3. Severe cardiovascular disease within 6 months prior to signing the ICF;
4. Heart rate \< 50 beats/min during screening period;
5. Subjects with poor blood pressure control during screening;
6. Severe arrhythmias or heart disease; the circulatory system is unstable;
7. Subjects with a history of severe cardiovascular disease, or cerebrovascular disease, or neurological disease, or mental illness
8. Subjects with a history of drug abuse;
9. Abnormal values of the laboratory examination;
10. Allergic to relevant drugs ingredient or component;
11. Pregnant or nursing women;
12. Subjects who has participated in clinical trials of other interventions recently;
13. Other conditions deemed unsuitable to be included.
18 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The Affiliated Hospital Of Guizhou Medical University
Guiyang, Guizhou, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Countries
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Other Identifiers
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HR7056-402
Identifier Type: -
Identifier Source: org_study_id