Study of Remimazolam Tosilate in Patients Undergoing Colonoscopy

Jiangsu HengRui Medicine Co., Ltd.388 enrolled

Overview

The purpose of this study is to evaluate the safety and efficacy of the sedation for Remimazolam or Propofol in patients undergoing colonoscopy.

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 (including 1 for Remimazolam Tosilate and 1 for propofol). Fentanyl are permitted before colonoscopy. Efficacy and safety profiles of Remimazolam Tosilate are to be evaluated.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

388

Conditions

Sedation

Interventions

Remimazolam TosilateDRUG

Initial dose plus supplemental doses as necessary

PropofolDRUG

Initial dose plus supplemental doses as necessary

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 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.

Locations (1)

Clinical trial Ethnics Committee of Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

rate of successful sedation

successful sedation rate as measured by the proportion of subjects who experienced successful sedation during colonoscopy