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.
Inclusion Criteria:
4. 18.0 kg/m2≤ body mass index (BMI) ≤28.0 kg/m2; 5. ASA grade I-II; 6. Female participants of childbearing potential must agree to use highly effective contraception with their partner and avoid egg donation from the time they sign the ICF until 1 month after the last dose of the investigational drug, have a negative serum pregnancy test during the screening period, and are not lactating; Men whose partner was a woman of childbearing potential agreed to use highly effective contraception with their partner and to avoid sperm donation from the time they signed the ICF until 1 month after the last dose of the investigational product.
Exclusion Criteria:
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Independent dispensing personnel were designated to conduct the trial, and both evaluators and participants remained blinded throughout. The trial drug was administered in accordance with the protocol. After blind verification, data were locked; the statistician then submitted an unblinding request. Specifically, the randomization and drug assignment codes were disclosed only to authorized statistical personnel to enable full analysis. Double-blinding was maintained unless broken for urgent clinical reasons-e.g. , serious adverse events or life-threatening emergencies-upon investigator decision, following immediate notification to the monitor, principal investigator, and sponsor. Unblinding authorization was pre-registered in the RTSM system. Once unblinded, the participant was classified as discontinued.
Safety and Efficacy of HRS-9190 Compared to Rocuronium for Tracheal Intubation in Adults
Safety and Efficacy of HRS-9190 Compared to Cisatracurium for Continuous Intravenous Infusion in Adults
Safety and Efficacy of HRS-9190 Compared to Rocuronium for Bolus Maintenance in Adults
Application of Low-dose Muscle Relaxants in Bronchoscopic Interventional Procedures
Sedation Compaired With Anesthesia With THRIVE in Endotracheal Intubation With Difficult Airways
Comparison of Intubation Conditions During Rapid Sequence Induction Obtained With Modified Time Principal Induction With a Standard Intubation Dose of Rocuronium Versus Succinylcholine
Muscle Relaxation for Short Procedures
Assessment of Remifentanil for Rapid Sequence Induction and Intubation in Full Stomach Patient Compared to Muscle Relaxant