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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03003884
Other study ID # HR-RMZL-IIc-UGE
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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 )]
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