Skeletal muscle relaxants
Conditions
Interventions
Rocuronium group:Administration of intravenous 0.6mg/kg rocuronium
0.4mg/kg HRS-9190 group:Administration of intravenous 0.4mg/kg HRS-9190
0.6mg/kg HRS-9190 group:Administration of intravenous 0.6mg/kg HRS-9190
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Before starting trial-related activities, participants should voluntarily sign an informed consent form, fully understand the purpose and significance of this trial, and voluntarily abide by the trial procedures; 2. Elective surgery requiring general anesthesia and tracheal intubation; 3.18 years old <= age <=65 years old, regardless of gender; 4.18= body mass index (BMI) <=28kg/m^2; 5. ASA grade I-II; 6. Expected anesthesia time (from induction to the end of surgery) within 2 hours; 7. Women of childbearing potential were required to agree to use highly effective contraception with their partner from the time they signed the informed consent until 1 month after the last dose of investigational drug, to avoid egg donation, to have a negative serum pregnancy test during the screening period, and to not be lactating; Men whose partner was a woman of childbearing potential agreed to use highly effective contraception with their partner and to avoid sperm donation from the time they provided written informed consent until 1 month after the last dose of the investigational product.
Exclusion criteria
Exclusion criteria: 1. Patients who planned to undergo cardiothoracic or extracerebral surgery during the study period; 2. Previous neuromuscular diseases: myasthenia gravis, myasthenic syndrome, myotonic disease, poliomyelitis; 3. Previous history of hereditary plasma cholinesterase deficiency; Patients with previous immune diseases requiring long-term steroid therapy; 4. Patients with a history of myocardial infarction or unstable angina within 6 months before screening, a history of severe arrhythmia such as atrioventricular block of degree II or above, or a history of NYHA class II or above; Hypertensive subjects who did not receive formal antihypertensive treatment or whose blood pressure was poorly controlled; Previous history of ischemic stroke or transient ischemic attack (TIA); Subjects with mental disorders (such as schizophrenia, depression, etc.) and cognitive impairment, or a history of epilepsy, or a history of psychotropic or narcotic drug abuse; 5. Severe respiratory diseases such as chronic obstructive pulmonary disease or bronchial asthma were assessed before operation. Or subjects with obstructive sleep apnea syndrome assessed by investigators who may be at risk for difficult intubation. 6. Abnormal body temperature >37.5? or 450ms, female >470ms; 10. Abnormal liver function during screening: aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >=1.5 times upper limit of normal value and/or total bilirubin (TBIL) >=1.5 times upper limit of normal value; Abnormal renal function during screening: serum creatinine (Cr) >=1.5 times upper limit of normal (ULN); 11. Patients with electrolyte disturbance, dehydration, acid/alkalosis, hypercapnia, etc. during the screening period were not suitable for this trial according to the investigator's evaluation; 12. HIV antibody positive, syphilis antibody positive, hepatitis B surface antigen positive, hepatitis C antibody positive; Previous and concomitant medications 13. Previous allergy to neuromuscular blocking drugs or other drugs that may be used during the trial; 14. The use of other drugs that affect the effect of muscle relaxation, the time from the last use to the random time is less than 5 half-lives (according to the actual drug instructions, the half-life is unknown, then the elution is carried out according to 48h) : Neuromuscular blockers, cholinesterase inhibitors or cholinergic drugs, monoamine oxidase inhibitors, antibiotics, diuretics, antiarrhythmic drugs, steroid hormones, antihistamines, anxiolytic/antidepressant/antiepileptic drugs, refer to the list of prohibited drugs). 15. Participation in another drug clinical trial (defined as receipt of the investigational drug or placebo) within 3 months before the screening period; 16. Other circumstances in which the participant was judged by the investigator to be ineligible for participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with excellent or good intubation conditions; | — |
Secondary
| Measure | Time frame |
|---|---|
| Onset time (s) : the time from the administration of the investigational drug to the maximum inhibition at T1;Time from administration of the investigational drug to completion of tracheal intubation (s);Action time (min) : the time from the administration of the test drug to the recovery of T1 to 10% and 25% of baseline; The time of drug administration to reach TOFr=40%, 70%, 90%;Recovery index (min) : the time for T1 to recover from 25% to 75% of the relative baseline, T1 to recover from 5% to 95% of the relative baseline;Muscle Relaxant Monitoring;Pharmacokinetics; | — |
Countries
China
Contacts
Public ContactWen Ouyang
The Third Xiangya Hospital of Central South University
Outcome results
None listed