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

A Multi-center, Open-label，Single-arm Clinical Trial to Evaluate the Efficacy and Safety of Remimazolam Tosilate for Injection for Sedation in Upper Gastrointestinal Endoscopy

The purpose of this study is to evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in Upper Gastrointestinal Endoscopy

Study Overview

• Status: Completed
• Conditions: Sedation in the Upper Gastrointestinal Endoscopy
• Intervention / Treatment: Drug: Remimazolam Tosilate

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guizhou
    • Guiyang, Guizhou, China, 550000
      • The Affiliated Hospital of Guizhou Medical University
  • Sichuan
    • Chengdu, Sichuan, China, 610072
      • Sichuan Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remimazolam Tosilate for Injection	Drug: Remimazolam Tosilate; bolus dose: 5mg，IV supplemental dose: 2.5mg，IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage(%) of paticipants who experienced successful sedation in Upper Gastrointestinal Endoscopy	on Day1

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2023
• Primary Completion (Actual): December 15, 2023
• Study Completion (Actual): December 16, 2023

Study Registration Dates

• First Submitted: December 6, 2023
• First Submitted That Met QC Criteria: December 6, 2023
• First Posted (Actual): December 14, 2023

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 25, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: HR7056-402

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No