Clinical trial NCT03003884: A Study of Remimazolam Tosilate in Patients Undergoing Diagnostic Upper GI Endoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sedation
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-12-28
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: successful sedation rate as measured by the proportion of subjects who experienced successful sedation during diagnostic upper GI endoscopy.
timeFrame: From start of study drug injection to patient discharge (approx. 3 hours)
Secondary outcomes:
measure: recovery time as measured by time
timeFrame: After the last of study drug injection to patient discharge (approx. 3 hours)
measure: rate of hypotension as measured by the proportion of subjects who experienced hypotension during a diagnostic upper GI endoscopy
timeFrame: From start of study drug injection to patient discharge (approx. 3 hours)
measure: rate of hypoxaemia as measured by the proportion of subjects who experienced hypoxaemia during a diagnostic upper GI endoscopy
timeFrame: From start of study drug injection to patient discharge (approx. 3 hours)
measure: rate of respiratory depression as measured by the proportion of subjects who experienced respiratory depression during a diagnostic upper GI endoscopy
timeFrame: From start of study drug injection to patient discharge (approx. 3 hours)
measure: pain on injection was assessed by the patient immediately after administration of the study drug
timeFrame: 1-10 minutes (from the beginning of sedation )]
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Union Medical College Hospital
state: Beijing
Study officials:
References: