Study of Remimazolam Tosilate in Patients Undergoing Diagnostic Upper GI Endoscopy

Sedation Clinical Trial

Official 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 Diagnostic Upper GI Endoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03425474
• Other study ID #: HR-RMZL-?-UGE
• Status: Completed
• Phase: Phase 3
• First received: September 16, 2017
• Last updated: February 9, 2018
• Start date: September 1, 2017
• Est. completion date: November 10, 2017

Study information

• Verified date: February 2018
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 378
• Est. completion date: November 10, 2017
• Est. primary completion date: November 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• subjects aged 18-60 years;

• intending to undergo diagnostic upper GI endoscopy;

• 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 gastroscopy;

• 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.

Related Conditions & MeSH terms

• Sedation

Intervention

Drug:
• Remimazolam Tosilate
Initial dose plus supplemental doses as necessary
• Propofol
Initial dose plus supplemental doses as necessary

Locations

Country	Name	City	State
China	Clinical trial Ethnics Committee of Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of successful sedation	successful sedation rate as measured by the proportion of subjects who experienced successful sedation during diagnostic upper GI endoscopy.	approximately 3 hours
Secondary	Sedation induction time	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.	approximately 3 hours
Secondary	Sedation recovery time	Sedation induction time is defined as from stop of study drug injection to be wide awake.	approximately 3 hours
Secondary	rate of hypotension	rate of hypotension as measured by the proportion of subjects who experienced hypotension during a diagnostic upper GI endoscopy	approximately 3 hours
Secondary	rate of respiratory depression	rate of respiratory depression as measured by the proportion of subjects who experienced respiratory depression during a diagnostic upper GI endoscopy	approximately 3 hours