Study of Remimazolam Tosilate in Patients Undergoing Diagnostic Upper GI Endoscopy
A Phase Ⅲ, Multicentre, Randomized, Single-blinded Study to Evaluate the Safety and Efficacy of the Sedation for Remimazolam or Propofol in Patients Undergoing Diagnostic Upper GI Endoscopy
1 other identifier
interventional
378
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2017
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2017
CompletedFirst Submitted
Initial submission to the registry
September 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 10, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 10, 2017
CompletedFirst Posted
Study publicly available on registry
February 7, 2018
CompletedFebruary 12, 2018
February 1, 2018
2 months
September 16, 2017
February 9, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
rate of successful sedation
successful sedation rate as measured by the proportion of subjects who experienced successful sedation during diagnostic upper GI endoscopy.
approximately 3 hours
Secondary Outcomes (4)
Sedation induction time
approximately 3 hours
Sedation recovery time
approximately 3 hours
rate of hypotension
approximately 3 hours
rate of respiratory depression
approximately 3 hours
Study Arms (2)
Remimazolam Tosilate
EXPERIMENTALRemimazolam Tosilate at 5mg for initial dose
Propofol
ACTIVE COMPARATORPropofol at 1.5mg/kg for initial dose
Interventions
Eligibility Criteria
You may qualify if:
- subjects aged 18-60 years；
- intending to undergo diagnostic upper GI endoscopy;
- ASA( American Society of Anesthesiologists) I or II；
- kg/m²\<BMI(Body Mass Index)\<30 kg/m²;
- the operation time of gastroscopy is not more than 30 min；
- Signed informed consent.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical trial Ethnics Committee of Peking Union Medical College Hospital
Beijing, Beijing Municipality, 010, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2017
First Posted
February 7, 2018
Study Start
September 1, 2017
Primary Completion
November 10, 2017
Study Completion
November 10, 2017
Last Updated
February 12, 2018
Record last verified: 2018-02