Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 38 of 39 for:    FLUMAZENIL

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03003884
Recruitment Status : Completed
First Posted : December 28, 2016
Last Update Posted : September 8, 2017
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Sedation Drug: Remimazolam Tosilate Drug: Propofol Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Study Start Date : November 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
Drug Information available for: Propofol

Arm Intervention/treatment
Experimental: Remimazolam Tosilate 1
IV of Remimazolam Tosilate at 5mg for initial dose
Drug: Remimazolam Tosilate
Initial dose plus supplemental doses as necessary.

Experimental: Remimazolam Tosilate 2
IV of Remimazolam Tosilate at 7mg for initial dose
Drug: Remimazolam Tosilate
Initial dose plus supplemental doses as necessary.

Experimental: Remimazolam Tosilate 3
IV of Remimazolam Tosilate at 8mg for initial dose
Drug: Remimazolam Tosilate
Initial dose plus supplemental doses as necessary.

Experimental: Remimazolam Tosilate 4
IV of Remimazolam Tosilate at 5mg for initial dose.At the end of the endoscopy, flumazenil was injected.
Drug: Remimazolam Tosilate
Initial dose plus supplemental doses as necessary.

Active Comparator: Propofol
IV of Propofol at 1.5mg/kg for initial dose
Drug: Propofol
Initial dose plus supplemental doses as necessary.




Primary Outcome Measures :
  1. successful sedation rate as measured by the proportion of subjects who experienced successful sedation during diagnostic upper GI endoscopy. [ Time Frame: From start of study drug injection to patient discharge (approx. 3 hours) ]

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03003884


Locations
Layout table for location information
China, Beijing
Beijing Union Medical College Hospital
Beijing, Beijing, China
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.

Layout table for additonal information
Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT03003884     History of Changes
Other Study ID Numbers: HR-RMZL-IIc-UGE
First Posted: December 28, 2016    Key Record Dates
Last Update Posted: September 8, 2017
Last Verified: December 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics