A Study of Remimazolam Tosilate for Sedation in Non-intubated Diagnostic and Therapeutic Procedures

NCT06216444 | Unknown Phase 4

• 1 other identifier: HR7056-401
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in non-intubated diagnostic and therapeutic procedures

Conditions

Sedation in Non-intubated Diagnostic and Therapeutic Procedures

Outcome Measures

Primary Outcomes (1)

• Rate of sedation success, Sedation success

  Rate of sedation success, Sedation success is defined as: 1) Completion of the entire non-intubated diagnostic and therapeutic procedure; 2) No need for additional rescue sedation; 3) During the sedation induction phase, the MOAA/S score should be ≤3 within 2 minutes after the end of the initial dose administration or after ≤2 additional administrations; 4) No more than 2 additional administrations in every 5-minute.

  day 1

Secondary Outcomes (11)

• Number of additional administrations.

  day 1

• Percentage of subjects needing additional administration.

  day 1

• One-time success rate of endoscope insertion during the diagnostic and therapeutic procedure.

  day 1

• Rate of over-sedation.

  day 1

• Sedation induction time

  day 1

Study Arms (2)

Remimazolam Tosilate for Injection（5mg）

EXPERIMENTAL

Drug: Remimazolam Tosilate for Injection

Remimazolam Tosilate for Injection（10mg）

EXPERIMENTAL

Drug: Remimazolam Tosilate for Injection

Interventions

Remimazolam Tosilate for Injection DRUG

Initial loading dose of 5mg, with additional doses of 2.5mg as necessary

Remimazolam Tosilate for Injection（5mg）

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years old, male or female
• Intending to undergo routine gastroscopy or colonoscopy
• ASA (American Society of Anesthesiologists) I to III
• kg/m2≤BMI (Body Mass Index)≤30kg/m2
• Signed informed consent

You may not qualify if:

• Subjects need to be tracheal intubation
• Subjects need to be complicated endoscopic diagnostic and therapeutic procedures
• Subjects who have had severe cardiovascular diseases or severe arrhythmias within 6 months prior to signing the ICF
• Heart rate \<50 beats/min during the screening period
• Poor blood pressure control during the screening period
• Subjects with severe respiratory diseases
• Subjects with respiratory management difficulties (Modified Mallampati grade IV)
• Subjects with a history of mental illness (schizophrenia, mania, bipolar disorder, psychosis, etc.), long-term use of psychotropic drugs, and cognitive impairment
• A history of drug abuse or addiction within 2 years prior to signing the ICF
• Pregnant women or those in lactation period
• Allergic to relevant drugs ingredient or component in the study
• Currently participating in or planning to participate in other drug or device clinical trials during this study
• Other conditions deemed unsuitable to be included

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Qin Liu

CONTACT

+0518-82342973; qin.liu@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2023
• First Posted: January 22, 2024
• Study Start: January 1, 2024
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: January 22, 2024

Record last verified: 2023-12

Locations

CN (1)