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

Jiangsu HengRui Medicine Co., Ltd.70 enrolled

Overview

The study will enroll adult patients scheduled for elective surgery requiring general anesthesia with tracheal intubation. 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, duration of action, and recovery profile of neuromuscular blockade. 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 for tracheal intubation, with a satisfied safety profile in the target patient population.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Neuromuscular Blockade

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 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. Scheduled for specific high-risk surgical procedures 2. History of significant neuromuscular, cardiovascular, respiratory, or neurological disorders 3. History of conditions affecting drug metabolism or anesthesia risk 4. Abnormal laboratory values indicating significant clinical abnormalities 5. Positive serology for specified infectious diseases 6. Known hypersensitivity to related medications 7. Recent use of medications interfering with neuromuscular function 8. History of mental illness, cognitive impairment, or epilepsy 9. Participation in another clinical trial within a specified period 10. Any other condition deemed unsuitable by the investigator 11. Pregnant or nursing women 12. Unwilling to use birth control during the specified period

Locations (2)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

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 to Maximum Inhibition (Onset Time)

The time from the start of injection of the study drug to the time when T1 reaches 0% of its baseline value, indicating complete neuromuscular blockade and maximum drug effect.

Time frame: From start of study drug administration until the time when T1 reaches 0% (maximum suppression), Estimated within 5 minutes

Time to Successful Tracheal Intubation

The time from the start of injection of the study drug to the time when the endotracheal tube is correctly placed and secured, as confirmed by the anesthesiologist.

Time frame: From start of study drug administration to the completion of tracheal intubation, Estimated within 5 minutes

Time to Recovery of T1 to 10%/25% of Baseline

The duration of action measured as the time from injection to the time when the first twitch (T1) recovers to 10%/25% of its pre-drug baseline height.

Time frame: From start of study drug administration until the time when T1 recovers to 10% /25% of its baseline value, Estimated within 30 minutes

Time to Recovery of Train-of-Four Ratio (TOFr) to 0.4/0.7/0.9

The time from injection to recovery of the ratio of the fourth twitch (T4) to the first twitch (T1) to 0.4, which is a marker of adequate recovery for spontaneous ventilation.

Time frame: From start of study drug administration until the time when the TOFr recovers to 0.4/0.7/0.9, Estimated from 15 to 90 minutes

Recovery Index (T1 25% to 75% and T1 5% to 95%)

Time frame: within 2 hours after administration of research drug