A Study of Remimazolam Tosilate for Sedation in the Upper Gastrointestinal Endoscopy

Phase 4

Completed

• Conditions: Sedation in the Upper Gastrointestinal Endoscopy
• Interventions: Drug: Remimazolam Tosilate

• Registration Number: NCT06169995
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-06
• Study First Submitted QC: 2023-12-06
• Study Start: 2023-12-11
• Study First Posted: 2023-12-14
• Primary Completion: 2023-12-15
• Study Completion: 2023-12-16
• Last Update Submitted: 2023-12-25
• Last Update Posted: 2023-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

1. patients or their guardians are able to provide a written informed consent
2. participants undergo upper gastrointestinal endoscopy
3. ≥18 years old, male or female
4. 18 kg/m2≤bmi≤30kg/m2

Exclusion Criteria

1. Subjects to be intubated (including laryngeal mask placement);
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Remimazolam Tosilate for Injection	Remimazolam Tosilate	-

Primary Outcome Measures

Name	Time	Method
Percentage(%) of paticipants who experienced successful sedation in Upper Gastrointestinal Endoscopy	on Day1

Secondary Outcome Measures

Name	Time	Method
Incidence of sedation hypotension.	on Day1
The number of supplemental doses of the research drug	on Day1
Wake-up time.	on Day1
Percentage of subjects receiving supplemental dose for sedation	on Day1
Incidence of respiratory depression	on Day1

Trial Locations

Locations (2)

The Affiliated Hospital Of Guizhou Medical University; 🇨🇳 Guiyang, Guizhou, China

Sichuan Provincial People's Hospital; 🇨🇳 Chengdu, Sichuan, China