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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06169995

Enrollment

Registered

2023-12-14

Start date

2023-12-11

Completion date

2023-12-16

Last updated

2023-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sedation in the Upper Gastrointestinal Endoscopy

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

Interventions

DRUGRemimazolam Tosilate

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026