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

Sedation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03003884
• Other study ID #: HR-RMZL-IIc-UGE
• Status: Completed
• Phase: Phase 2
• First received: December 22, 2016
• Last updated: September 6, 2017
• Start date: November 2016
• Est. completion date: March 2017

Study information

• Verified date: December 2016
• 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 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: March 2017
• Est. primary completion date: March 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

• 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

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	Beijing 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	successful sedation rate as measured by the proportion of subjects who experienced successful sedation during diagnostic upper GI endoscopy.		From start of study drug injection to patient discharge (approx. 3 hours)
Secondary	recovery time as measured by time		After the last of study drug injection to patient discharge (approx. 3 hours)
Secondary	rate of hypotension as measured by the proportion of subjects who experienced hypotension during a diagnostic upper GI endoscopy		From start of study drug injection to patient discharge (approx. 3 hours)
Secondary	rate of hypoxaemia as measured by the proportion of subjects who experienced hypoxaemia during a diagnostic upper GI endoscopy		From start of study drug injection to patient discharge (approx. 3 hours)
Secondary	rate of respiratory depression as measured by the proportion of subjects who experienced respiratory depression during a diagnostic upper GI endoscopy		From start of study drug injection to patient discharge (approx. 3 hours)
Secondary	pain on injection was assessed by the patient immediately after administration of the study drug		1-10 minutes (from the beginning of sedation )]