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OpenTrials
Completed

NCT Number: NCT06169995

A Study of Remimazolam Tosilate for Sedation in the 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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Affiliated Hospital Of Guizhou Medical University, Guiyang, Guizhou, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Remimazolam Tosilate

Drug

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

Primary outcomes

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

    Time frame: on Day1

Secondary outcomes

  1. Percentage of subjects receiving supplemental dose for sedation

    Time frame: on Day1

  2. The number of supplemental doses of the research drug

    Time frame: on Day1

  3. Wake-up time.

    Time frame: on Day1

  4. Incidence of sedation hypotension.

    Time frame: on Day1

  5. Incidence of respiratory depression

    Time frame: on Day1

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 14, 2023
Registry last updated
Dec 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.