Status:
COMPLETED
Study of Remimazolam Tosilate in Patients Undergoing Colonoscopy
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Sedation
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of the sedation for Remimazolam or Propofol in patients undergoing colonoscopy.
Detailed Description
This is a multi-center, parallel-group, single blind study using Remimazolam or propofol for sedation in patients undergoing colonoscopy.Subjects are randomized to different treatment groups (includin...
Eligibility Criteria
Inclusion
- subjects aged 18-65 years；
- intending to undergo colonoscopy;
- 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
- Patients need to be Complicated colonoscopy;
- 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.
Key Trial Info
Start Date :
June 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 28 2018
Estimated Enrollment :
388 Patients enrolled
Trial Details
Trial ID
NCT03779061
Start Date
June 28 2018
End Date
September 28 2018
Last Update
December 19 2018
Active Locations (1)
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1
Clinical trial Ethnics Committee of Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 010