Safety and Efficacy of HRS-9190 Compared to Rocuronium for Tracheal Intubation and Bolus Maintenance in Adults

Phase 3RecruitingNCT07746726

Jiangsu HengRui Medicine Co., Ltd.320 enrolled

Overview

The study will enroll adult patients scheduled for elective surgery requiring general anesthesia. Participants will be randomly assigned to receive either HRS-9190 for Injection or Rocuronium. The primary objective is to assess the efficacy of HRS-9190 in providing adequate neuromuscular blockade for successful tracheal intubation. Secondary objectives include evaluating the onset time and duration of action following each dose, the total time adequate muscle relaxation is maintained during surgery, and the detailed pattern of neuromuscular recovery. Safety assessments will include monitoring of adverse events, vital signs, laboratory parameters, and other safety indicators throughout the study period. The hypothesis of this study is that HRS-9190 for Injection could provide effective neuromuscular relaxation, with a satisfied safety profile in the target patient population.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

320

Conditions

Neuromuscular Blockade

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Able and willing to provide a written informed consent 2. Subjects requiring elective general anesthesia surgery 3. Meet specified age and body mass index (BMI) criteria 4. Conform to the ASA Physical Status Classification 5. Use of highly effective contraception for a specified period if applicable Exclusion Criteria: 1. History of significant neuromuscular, cardiovascular, respiratory, or neurological disorders 2. History of conditions affecting drug metabolism or anesthesia risk 3. Abnormal laboratory values indicating significant clinical abnormalities 4. Positive serology for specified infectious diseases 5. Known hypersensitivity to related medications 6. Recent use of medications interfering with neuromuscular function 7. History of mental illness, cognitive impairment, or epilepsy 8. Participation in another clinical trial within a specified period 9. Any other condition deemed unsuitable by the investigator

Locations (2)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

RECRUITING

Outcomes

Primary Outcomes

Intubation conditions

Proportion of subjects with excellent or good intubation conditions as assessed by the Cooper score

Time frame: Within 5 minutes after administration of the study drug

Secondary Outcomes

Time from last dose to recovery from T1% 25% to TOFr ≥90%

Time from last dose of study drug to recovery from T1% 25% to TOFr ≥90% (minutes)

Time frame: Within 2 hours after last dose administration

Time to Tracheal Intubation

Time from administration of study drug to completion of tracheal intubation during the induction period

Time frame: Within 5 minutes after administration of study drug during induction

Onset Time

Time from each administration of study drug to maximum suppression of T1%.

Time frame: Within 30 minutes after each dose of study drug

Duration of Action

Includes: time from each dose to start of T1% recovery; time to T1% recovery to 10% and 25%; time from last dose to achievement of TOFr 40%, 70%, and 90%

Time frame: Up to 2 hours after each dose of study drug

Percentage of Time Maintaining Target Neuromuscular Blockade Level

Proportion of time during which T1% is maintained ≤25% relative to the total drug administration time

Time frame: Throughout the drug administration period, up to 6 hours

Time to Tracheal Extubation

Time from the last dose of study drug to removal of the tracheal tube

Time frame: up to 2 hours after the last dose of study drug

Recovery Index

Includes: time for T1% recovery from 25% to 75%; time for T1% recovery from 5% to 95%; time from T1% recovery to 10% to achievement of TOFr ≥90%

Time frame: up to 2 hours after the last dose of study drug

Anesthesiologist's Overall Satisfaction Score

The overall satisfaction score regarding the quality and ease of neuromuscular management, rated by the attending anesthesiologist using a predefined scale.

Time frame: Assessed at the end of the surgical procedure, within 1 hour.

Surgeon's Overall Satisfaction Score

The overall satisfaction score regarding surgical conditions related to muscle relaxation, rated by the operating surgeon using a predefined scale.