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Completed

NCT Number: NCT03779061

Study of Remimazolam Tosilate in Patients Undergoing Colonoscopy

The purpose of this study is to evaluate the safety and efficacy of the sedation for Remimazolam or Propofol in patients undergoing colonoscopy.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical trial Ethnics Committee of Peking Union Medical College Hospital

Beijing, Beijing Municipality, 010, China

About this study

This is a multi-center, parallel-group, single blind study using Remimazolam or propofol for sedation in patients undergoing colonoscopy.Subjects are randomized to different treatment groups (including 1 for Remimazolam Tosilate and 1 for propofol). Fentanyl are permitted before colonoscopy. 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 18-65 years;
  • intending to undergo colonoscopy;
  • ASA( American Society of Anesthesiologists) I or II;
  • 18 kg/m²<BMI(Body Mass Index)<30 kg/m²;
  • the operation time of gastroscopy is not more than 30 min;
  • Signed informed consent.

Exclusion criteria

Patients need to be Complicated colonoscopy;

  • Patients need to be Tracheal intubation;
  • Patients with respiratory management difficulties (Modified Mallampati grade IV);
  • one or more of the laboratory findings fall out of the limitations for this study(platelet,hemoglobin,aspartate aminotransferase,etc.);
  • A history of drug abuse and / or alcohol abuse 2 years prior to the screening period;
  • allergic to drugs used in the study;
  • pregnant women or those in lactation period
  • The subject has participated in other clinical trial within the 3 months prior to randomization.

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. rate of successful sedation

    Time frame: approximately 3 hours

    successful sedation rate as measured by the proportion of subjects who experienced successful sedation during colonoscopy

Secondary outcomes

  1. Sedation induction time

    Time frame: approximately 3 hours

    Sedation induction time is defined as from start of study drug injection to the first time of MOAA/S(The Observer's Assessment of Alertness/Sedation Scale) ≤ 3.

  2. Sedation recovery time

    Time frame: approximately 3 hours

    Sedation induction time is defined as from stop of study drug injection to be wide awake.

  3. rate of hypotension

    Time frame: approximately 3 hours

    rate of hypotension as measured by the proportion of subjects who experienced hypotension

  4. rate of respiratory depression

    Time frame: approximately 3 hours

    rate of respiratory depression as measured by the proportion of subjects who experienced respiratory depression

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

A Phase Ⅲ, Multicentre, Randomized, Single-blinded Study to Evaluate the Safety and Efficacy of the Sedation for Remimazolam or Propofol in Patients Undergoing Colonoscopy

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 19, 2018
Registry last updated
Dec 19, 2018

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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