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Completed

NCT Number: NCT03003884

A Study of Remimazolam Tosilate in Patients Undergoing Diagnostic Upper GI Endoscopy

The purpose of this study is to find out the optimal dose for Remimazolam Tosilate as a procedural sedative during a diagnostic upper GI endoscopy and to assess its efficacy and safety profile comparing to propofol.

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Key information

Conditions

Sedation

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Union Medical College Hospital

Beijing, Beijing Municipality, China

About this study

This is an multi-center,single-blinded,parallel-group,dose-finding study using Remimazolam or propofol for sedation in patients undergoing diagnostic upper GI endoscopy.Subjects are randomized to different treatment groups (including 4 for Remimazolam Tosilate and 1 for propofol).Lidocaine and fentanyl are permitted during a diagnostic upper GI endoscopy.Efficacy and safety profiles of Remimazolam Tosilate are to be evaluated.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • subjects aged 18-60 years；
  • intending to undergo diagnostic upper GI endoscopy
  • American Society of Anesthesiologists Physical Status Score (ASA PS) I or II；
  • 18 kg/m²<BMI(Body Mass Index)<30 kg/m².

Exclusion criteria

  • Patients with a suspected upper GI bleed an conditions predisposing to hemorrhage at the discretion of the investigator;
  • one or more of the laboratory findings fall out of the limitations for this study(platelet,hemoglobin,aspartate aminotransferase,etc.);
  • history of recent use of narcotics,analgesics,anaesthetics and benzodiazepine hypnotics;
  • history of severe cardiovascular disease;
  • cerebral disease or mental disorder;
  • allergic to drugs used in the study;
  • pregnant women or those in lactation period

Treatment and study plan

Remimazolam Tosilate

Drug

Initial dose plus supplemental doses as necessary.

Propofol

Drug

Initial dose plus supplemental doses as necessary.

Primary outcomes

  1. successful sedation rate as measured by the proportion of subjects who experienced successful sedation during diagnostic upper GI endoscopy.

    Time frame: From start of study drug injection to patient discharge (approx. 3 hours)

Secondary outcomes

  1. recovery time as measured by time

    Time frame: After the last of study drug injection to patient discharge (approx. 3 hours)

  2. rate of hypotension as measured by the proportion of subjects who experienced hypotension during a diagnostic upper GI endoscopy

    Time frame: From start of study drug injection to patient discharge (approx. 3 hours)

  3. rate of hypoxaemia as measured by the proportion of subjects who experienced hypoxaemia during a diagnostic upper GI endoscopy

    Time frame: From start of study drug injection to patient discharge (approx. 3 hours)

  4. rate of respiratory depression as measured by the proportion of subjects who experienced respiratory depression during a diagnostic upper GI endoscopy

    Time frame: From start of study drug injection to patient discharge (approx. 3 hours)

  5. pain on injection was assessed by the patient immediately after administration of the study drug

    Time frame: 1-10 minutes (from the beginning of sedation )]

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 28, 2016
Registry last updated
Sep 8, 2017

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.

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