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ENROLLING BY INVITATION
NCT07733245
PHASE3

Efficacy and Safety of HRS-9190 in General Anesthesia

Sponsor: The Third Xiangya Hospital of Central South University

View on ClinicalTrials.gov

Summary

A multicenter, randomized, double - blind, placebo - controlled, parallel - group phase III clinical trial was carried out to evaluate the efficacy and safety of HRS - 9190 for skeletal muscle relaxation during tracheal intubation in the induction and maintenance phases of general anesthesia. The primary objective was to evaluate the effectiveness of HRS - 9190 in achieving skeletal muscle relaxation during tracheal intubation in the induction and maintenance phases of general anesthesia. The secondary objective was to assess the safety and pharmacokinetic profile of HRS - 9190.

Official title: To Evaluate the Efficacy and Safety of HRS-9190 for Injection in Tracheal Intubation During Induction and Skeletal Muscle Relaxation During Maintenance of General Anesthesia in a Multi-center, Randomized, Double-blind, Positive Drug Parallel Controlled Phase III Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

320

Start Date

2026-09-02

Completion Date

2027-03-31

Last Updated

2026-09-09

Healthy Volunteers

No

Interventions

DRUG

Administration of intravenous HRS-9190

During the induction phase, 0.6 mg/kg of HRS-9190 was administered intravenously, and during the maintenance phase, 0.2 mg/kg of HRS-9190 was administered intravenously.

DRUG

Administration of intravenous rocuronium

During the induction phase, 0.6 mg/kg of rocuronium was administered intravenously, and during the maintenance phase, 0.15 mg/kg of rocuronium was administered intravenously.

Locations (1)

The Third Xiangya Hospital of Central South University, Changsha, hunan

Changsha, Hunan, China