Efficacy and Safety of HRS-9190 in General Anesthesia (NCT07733245) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Efficacy and Safety of HRS-9190 in General Anesthesia
China320 participantsStarted 2026-07-28
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Voluntarily sign ICF before starting trial-related activities, fully understand the purpose and significance of this trial, and voluntarily abide by the process of this trial;
. For elective surgery, tracheal intubation should be performed under general anesthesia and intermittent drug administration is suitable for intraoperative muscle relaxation maintenance, and the operation time is expected to be 1.5-4 hours; 3.18 years old ≤ age ≤75 years old, regardless of gender;
. a history of myocardial infarction or unstable angina, a history of severe arrhythmia such as atrioventricular block degree II or higher, or a history of New York Heart Association (NYHA) functional class II or higher within 6 months before screening that was deemed by the investigator to increase the risk of sedation/anesthesia; Participants with hypertension or hypotension who had poorly controlled blood pressure (systolic blood pressure ≥160 mmHg or ≤90 mmHg at screening; and/or diastolic blood pressure ≥100 mmHg or ≤60 mmHg at screening); Previous history of ischemic stroke or transient ischemic attack (TIA); Participants with psychiatric disorders (e.g., schizophrenia, depression, etc.) and cognitive impairment, or a history of epilepsy, or previous history of psychotropic or narcotic drug abuse;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of participants with excellent or good intubation conditions at the time of tracheal intubation
Timeframe: From the beginning of the drug to 5 minutes after the administration
Trial details
NCT IDNCT07733245
SponsorThe Third Xiangya Hospital of Central South University
. The presence of severe respiratory diseases such as chronic obstructive pulmonary disease or bronchial asthma; Or those with obstructive sleep apnea syndrome, as assessed by investigators, who might be at risk for difficult intubation;
. abnormal body temperature \>37.5℃ or \<36℃ during the screening period; He had a history of malignant high fever. Hypothermia surgery was planned.
. having a history of drug, drug, or alcohol abuse within 1 year before randomization
. Abnormal liver function during screening: aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≥1.5 times upper limit of normal (ULN) and/or total bilirubin (TBIL) ≥1.5 times ULN; Abnormal renal function during screening: serum creatinine (Cr) ≥1.5 times upper limit of normal (ULN); Serum albumin (ALB) during screening was less than 35g/L;
. electrolyte disturbance or known dehydration, acid/alkalosis, hypercapnia, or other factors assessed by the investigator during the screening period;