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Study on the Safety and Effectiveness of Remimazolam Tosilate for Injection for Short-term Elective Surgery in Adults

NCT04908553 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 650

Last updated 2025-06-29

No results posted yet for this study

Summary

Research objective: To explore the safety and dose exploration of Remimazolam Tosilate for Injection for induction and maintenance of general anesthesia in elective short-term surgery in adults.

Main research indicators:(1)Success rate of sedation during induction and maintenance of general anesthesia with remazolam tosylate;(2)The incidence and severity of hypotension in the induction and maintenance phases Study design: Multi-center, randomized, double-blind clinical study. Subject population: patients undergoing elective short-term surgery. Research data collection period: The subject signs the consent form until discharge or death in the hospital or withdrawal from the research.

Number of research centers/sample size: It is planned to enroll 600 patients from 11 hospitals.

Research process: The researchers will include patients who meet the enrollment criteria and agree to participate in the investigation of the support laryngoscope surgery and minor head and neck surgery patients from the elective surgery patients.

Conditions

  • Hypotension During Surgery

Interventions

DRUG

Remimazolam Tosilate for Injection 0.1mg/kg

Remimazolam Tosilate for Injection 0.1mg/kg at induction

DRUG

Remimazolam Tosilate for Injection 0.15mg/kg

Remimazolam Tosilate for Injection 0.15mg/kg at induction

DRUG

Remimazolam Tosilate for Injection 0.2mg/kg

Remimazolam Tosilate for Injection 0.2mg/kg at induction

Sponsors & Collaborators

  • Tongji Hospital

    lead OTHER

Principal Investigators

  • Ailin Luo, Doctor · Tongji Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2025-03-30
Completion
2025-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04908553 on ClinicalTrials.gov