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Study of Remimazolam Tosilate in Patients Undergoing Colonoscopy

NCT ID: NCT03779061

Last Updated: 2018-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

388 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-28

Study Completion Date

2018-09-28

Brief Summary

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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

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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.

Conditions

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Sedation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Single (Participant)

Study Groups

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Remimazolam Tosilate

Group Type EXPERIMENTAL

Remimazolam Tosilate

Intervention Type DRUG

Initial dose plus supplemental doses as necessary

Propofol

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

Initial dose plus supplemental doses as necessary

Interventions

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Remimazolam Tosilate

Initial dose plus supplemental doses as necessary

Intervention Type DRUG

Propofol

Initial dose plus supplemental doses as necessary

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinical trial Ethnics Committee of Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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HR-RMZL-Ⅲ-PEC

Identifier Type: -

Identifier Source: org_study_id