NCT04908553

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

Safety and Dose Exploration of Remimazolam Tosilate for Injection for Induction and Maintenance of General Anesthesia Intubation for Elective Short-term Surgery in Adults: a Multi-center, Randomized, Double-blind Clinical Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 650 (actual)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The data collected in this study is recorded by the researcher in the eCRF, including: 1. Data to be collected during the screening period and before the operation: the basic characteristics of the patient and demographic data; 2. Data to be recorded during and/or postoperatively: main research indicators, secondary indicators and other indicators.

Conditions

• Hypotension During Surgery

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-07-01
• Primary completion: 2025-03-30
• Completion: 2025-05-31
• First posted: 2021-06-01
• Last updated: 2025-06-29

Locations

1 site across 1 country: China