Study of Remimazolam Tosilate in Patients Undergoing Diagnostic Upper GI Endoscopy

Phase 3

Completed

• Conditions: Sedation
• Interventions: Drug: Remimazolam Tosilate; Drug: Propofol

• Registration Number: NCT03425474
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2017-09-16
• Primary Completion: 2017-11-10
• Study Completion: 2017-11-10
• Status Verified: 2018-02
• Study First Submitted QC: 2018-02-01
• Study First Posted: 2018-02-07
• Last Update Submitted: 2018-02-09
• Last Update Posted: 2018-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 378

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remimazolam Tosilate	Remimazolam Tosilate	Remimazolam Tosilate at 5mg for initial dose
Propofol	Propofol	Propofol at 1.5mg/kg for initial dose

Primary Outcome Measures

Name	Time	Method
rate of successful sedation	approximately 3 hours	successful sedation rate as measured by the proportion of subjects who experienced successful sedation during diagnostic upper GI endoscopy.

Secondary Outcome Measures

Name	Time	Method
rate of hypotension	approximately 3 hours	rate of hypotension as measured by the proportion of subjects who experienced hypotension during a diagnostic upper GI endoscopy
Sedation induction time	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.
Sedation recovery time	approximately 3 hours	Sedation induction time is defined as from stop of study drug injection to be wide awake.
rate of respiratory depression	approximately 3 hours	rate of respiratory depression as measured by the proportion of subjects who experienced respiratory depression during a diagnostic upper GI endoscopy

Trial Locations

Locations (1)

Clinical trial Ethnics Committee of Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China