Study of Remimazolam Tosilate in Patients Undergoing Colonoscopy

NCT03779061 | Completed Phase 3 DMC

• 1 other identifier: HR-RMZL-Ⅲ-PEC
• Study Type: interventional
• Target: 388
• Locations: 1 country
• Sites: 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 colonoscopy.

Conditions

Sedation

Outcome Measures

Primary Outcomes (1)

• rate of successful sedation

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

  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

EXPERIMENTAL

Drug: Remimazolam Tosilate

Propofol

ACTIVE COMPARATOR

Drug: Propofol

Interventions

Remimazolam Tosilate DRUG

Initial dose plus supplemental doses as necessary

Remimazolam Tosilate

Propofol DRUG

Initial dose plus supplemental doses as necessary

Propofol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• subjects aged 18-65 years；
• intending to undergo colonoscopy;
• 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 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Clinical trial Ethnics Committee of Peking Union Medical College Hospital

Beijing, Beijing Municipality, 010, China

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Single (Participant)
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2018
• First Posted: December 19, 2018
• Study Start: June 28, 2018
• Primary Completion: September 20, 2018
• Study Completion: September 28, 2018
• Last Updated: December 19, 2018

Record last verified: 2018-07

Locations

CN (1)