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

Hypotension During Surgery Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04908553
Study type Interventional
Source Tongji Hospital
Contact
Status Completed
Phase Phase 4
Start date July 1, 2021
Completion date January 31, 2023
View Details
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