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

NCT06169995 | Completed Phase 4

• 1 other identifier: HR7056-402
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

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

Conditions

Sedation in the Upper Gastrointestinal Endoscopy

Outcome Measures

Primary Outcomes (1)

• Percentage(%) of paticipants who experienced successful sedation in Upper Gastrointestinal Endoscopy

  on Day1

Secondary Outcomes (5)

• 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

Study Arms (1)

Remimazolam Tosilate for Injection

EXPERIMENTAL

Drug: Remimazolam Tosilate

Interventions

Remimazolam Tosilate DRUG

bolus dose: 5mg，IV supplemental dose: 2.5mg，IV

Remimazolam Tosilate for Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (2)

The Affiliated Hospital Of Guizhou Medical University

Guiyang, Guizhou, 550000, China

Location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: December 14, 2023
• Study Start: December 11, 2023
• Primary Completion: December 15, 2023
• Study Completion: December 16, 2023
• Last Updated: December 29, 2023

Record last verified: 2023-12

Locations

CN (2)