Safety and Efficacy of HRS-9190 Compared to Cisatracurium for Continuous Intravenous Infusion in Adults

A Phase II, Multicenter, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Efficacy and Safety of Continuous Intravenous Infusion of HRS-9190 Versus Cisatracurium for Maintaining Neuromuscular Blockade During General Anesthesia in Adults Undergoing Elective Surgery.

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 Cisatracurium. The primary objective is to measure the duration from cessation of the study drug infusion until the recovery of neuromuscular function to a specific level (TOFr ≥ 90%). Secondary objectives include onset time, duration of action, total time of adequate muscle relaxation during surgery, and neuromuscular recovery pattern.. 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 Overview

• Status: Recruiting
• Conditions: Neuromuscular Blockade
• Intervention / Treatment: Drug: HRS-9190; under Inhalational Anesthesia; Drug: HRS-9190; under Intravenous Anesthesia; Drug: Cisatracurium (under Inhalational Anesthesia).; Drug: Cisatracurium (under Intravenous Anesthesia)

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Lei Tang; Phone Number: +0518-81220121; Email: lei.tang.lt31@hengrui.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Recruiting
      • ZhongShan Hospital FuDan University
      • Principal Investigator: Changhong Miao
  • Shanxi
    • Taiyuan, Shanxi, China, 030012
      • Recruiting
      • Shanxi Provincial People's Hospital
      • Principal Investigator: Shouyuan Tian

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A: HRS-9190 under Inhalational Anesthesia	Drug: HRS-9190; under Inhalational Anesthesia; HRS-9190; under Inhalational Anesthesia
Experimental: Treatment group B: HRS-9190 under Intravenous Anesthesia	Drug: HRS-9190; under Intravenous Anesthesia; HRS-9190; under Intravenous Anesthesia
Active Comparator: Treatment group C: Cisatracurium under Inhalational Anesthesia	Drug: Cisatracurium (under Inhalational Anesthesia).; Cisatracurium (under Inhalational Anesthesia).
Active Comparator: Treatment group D: Cisatracurium under Intravenous Anesthesia.	Drug: Cisatracurium (under Intravenous Anesthesia); Cisatracurium (under Intravenous Anesthesia)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from Cessation of Infusion to Recovery of TOFr to 0.9	The duration (in minutes) from the cessation of the continuous intravenous infusion of the neuromuscular blocking agent to the recovery of the Train-of-Four ratio (TOFr) to 90% or greater	From the end of continuous infusion of the study drug until the time point when TOFr ≥ 90% is first achieved, assessed intraoperatively and in the immediate postoperative period, up to 2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery Index	The recovery time (in minutes) for T1 to recover from 25% to 75% of baseline, and from 5% to 95% of baseline, following the last dose.	After the last dose: from T1=25% to T1=75%, and from T1=5% to T1=95%, assessed intraoperatively and in recovery, up to 2 hours.
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.	Assessed at the end of the surgical procedure, within 1 hour.
Time from the Cessation of Study Drug Infusion to Recovery of T1% to 10% and 25%	The duration (in minutes) from the cessation of the study drug infusion to the recovery of the first twitch (T1%) of Train-of-Four stimulation to 10% and 25% of the control height, respectively.	From the cessation of study drug infusion until T1% recovers to 10% and 25%, respectively, assessed intraoperatively and in the recovery period, up to 2 hours
Time from the Cessation of Study Drug Infusion to Recovery of TOFr to 0.4 and 0.7	The duration (in minutes) from the cessation of the study drug infusion to the recovery of TOFr to 40% or greater and 70% or greater, respectively.	From the cessation of study drug infusion until TOFr ≥ 0.4 and TOFr ≥ 0.7 are achieved, assessed intraoperatively and in the recovery period, up to 2 hours.
Percentage of Time that Target Neuromuscular Block Level (T1% 1% to 10%) is Maintained During Study Drug Administration	The proportion (%) of the total study drug administration duration during which the T1% is maintained within the target neuromuscular block level range (1% to 10% of control height).	From the initiation of study drug infusion until its cessation, assessed intraoperatively, up to 6 hours.
Mean Infusion Rate of Study Drug and Mean T1%	The average infusion rate (μg/kg/min) of the study drug and the corresponding average T1% throughout the drug administration period.	From the initiation of study drug infusion until its cessation, assessed intraoperatively, up to 6 hours.
Time to Successful Airway Device Placement	The time (in minutes) from the administration of the study drug for induction to the completion of tracheal intubation or laryngeal mask placement.	From administration of the initial intubating dose to completion of tracheal intubation or laryngeal mask insertion, assessed at induction, approximately 3-5 minutes.
Time from Study Drug Administration (Induction Phase) to Maximum T1% Suppression	The duration (in minutes) from the administration of the initial dose of the study drug (induction phase) to the time point when T1% reaches its maximum suppression.	From the administration of the first dose of the study drug (induction phase) until the maximum suppression of T1% is observed, assessed intraoperatively, up to 30 minutes.
Time from Study Drug Administration (Induction Phase) to Onset of T1% Recovery	The duration (in minutes) from the administration of the initial dose of the study drug (induction phase) to the onset of T1% recovery.	From the administration of the study drug (induction phase) until the T1% begins to recover from its maximum suppression, assessed intraoperatively, up to 2 hours.
Time from the Cessation of Study Drug Infusion to Extubation or Removal of the Laryngeal Mask Airway	The duration (in minutes) from the cessation of the study drug infusion to the removal of the tracheal tube or laryngeal mask airway.	From the cessation of study drug infusion until the removal of the tracheal tube or laryngeal mask airway, assessed in the operating room or recovery period, up to 2 hours
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.	Assessed at the end of the surgical procedure, within 1 hour

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): April 10, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: February 26, 2026
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): March 3, 2026

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: cisatracurium
• Other Study ID Numbers: HRS-9190-203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No