Overview

Study of Remimazolam Tosilate in Patients Undergoing Colonoscopy

Status:
Completed
Trial end date:
2018-09-28
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the safety and efficacy of the sedation for Remimazolam or Propofol in patients undergoing colonoscopy.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Treatments:
Propofol
Criteria
Inclusion Criteria:

- subjects aged 18-65 years;

- intending to undergo colonoscopy;

- ASA( American Society of Anesthesiologists) I or II;

- 18 kg/m²
- the operation time of gastroscopy is not more than 30 min;

- Signed informed consent.

Exclusion Criteria:

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.