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

ConditionNeuromuscular Blockade
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJiangsu HengRui Medicine Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able and willing to provide a written informed consent

Subjects requiring elective general anesthesia surgery

Meet specified age and body mass index (BMI) criteria

Conform to the ASA Physical Status Classification

Disqualifiers

Scheduled for specific high-risk surgical procedures

History of significant neuromuscular, cardiovascular, respiratory, or neurological disorders

History of conditions affecting drug metabolism or anesthesia risk

Abnormal laboratory values indicating significant clinical abnormalities

Trial design

Design model

Parallel

Treatments tested in this trial

  • HRS-9190; under Inhalational Anesthesia

    Drug

    HRS-9190; under Inhalational Anesthesia

  • HRS-9190; under Intravenous Anesthesia

    Drug

    HRS-9190; under Intravenous Anesthesia

  • Cisatracurium (under Inhalational Anesthesia).

    Drug

    Cisatracurium (under Inhalational Anesthesia).

  • Cisatracurium (under Intravenous Anesthesia)

    Drug

    Cisatracurium (under Intravenous Anesthesia)

Treatment groups

60 Participants
are divided into 4 treatment groups
Group A: Treatment group A: HRS-9190 under Inhalational AnesthesiaExperimental treatment 1 intervention
Group B: Treatment group B: HRS-9190 under Intravenous AnesthesiaExperimental treatment 1 intervention
Group C: Treatment group C: Cisatracurium under Inhalational AnesthesiaActive comparator 1 intervention
Group D: Treatment group D: Cisatracurium under Intravenous Anesthesia.Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
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 outcomes

1

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.

Time frame
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
2

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.

Time frame
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.
3

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).

Time frame
From the initiation of study drug infusion until its cessation, assessed intraoperatively, up to 6 hours.
4

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.

Time frame
From the initiation of study drug infusion until its cessation, assessed intraoperatively, up to 6 hours.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jiangsu HengRui Medicine Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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