Changes in heart rate
Conditions
Interventions
Experimental Group:Glycopyrronium and neostigmine injection + sodium chloride injection were intravenously injected
Positive control group:Neostigmine methylsulfate injection + atropine sulfate injection was intravenously injected
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Male or female subjects aged from 18 to 65 years old (including 18 and 65 years old) when signing the informed consent form; 2) Body mass index (BMI) = weight (kg)/height (m2) in the range of 19.0-28.0 kg/m2 (including critical value); 3) Elective non-cardiac surgery under general anesthesia with expected anesthesia duration of 1 h to 4 h, neostigmine can be used to antagonize the residual muscle relaxant effect of non-depolarizing muscle relaxant after surgery; 4) American Society of Anesthesiologists (ASA) grade I or II; 5) subjects (including their partners) who have no plans to have children during the screening period and within 3 months after drug administration, voluntarily take effective contraceptive measures, and have no plans to donate sperm or eggs; 6) fully understand the purpose, content, process and possible adverse reactions of the trial, and voluntarily sign an informed consent form before the start of any trial procedure; 7) Able to communicate well with investigators and understand and comply with the requirements of the trial.
Exclusion criteria
Exclusion criteria: 1) a history of allergy to glycopyrronium bromide, neostigmine methylsulfate, atropine sulfate, or any drug component, or a history of allergy to two or more drugs and/or foods; 2) patients with glaucoma and hyperthyroidism; 3) patients with severe cardiovascular and cerebrovascular diseases, such as coronary heart disease, congestive heart failure, severe arrhythmia (atrial flutter, atrial fibrillation, grade II-III atrioventricular block, etc.), myocardial infarction, stroke, transient cerebral ischemia, etc. 4) patients with reflux esophagitis (except asymptomatic patients), hiatal hernia, ulcerative colitis, toxic megacolon, pyloric obstruction, and intestinal obstruction; 5) patients with a history of ileal or colostomy surgery or planned to undergo such surgery during the trial period; 6) patients with urinary obstruction such as prostatic hypertrophy; 7) patients with autonomic neuropathy such as myasthenia gravis, epilepsy, and increased vagal tone; 8) patients with a history of bronchial asthma or other airway hyperresponsiveness diseases; 9) known or suspected history of malignant high fever or family history; 10) are using drugs affecting the cholinergic system or drugs with anticholinergic activity (e.g., phenothiazines, antipas) Kinson drugs, tricyclic antidepressants); People who are using drugs that act on adrenergic receptors (including b-blockers such as metoprolol, b-agonists such as isoproterenol, etc.); In use Antispasmodic drugs, aminoglycoside antibiotics, magnesium salts (except supplement to maintain physiological levels); 11) body temperature >38°C during screening; 12) patients with uncontrolled hypertension at screening, defined as resting systolic blood pressure >=140 mmHg, and (or) diastolic blood pressure >=90 mmHg; Hypotension, defined as resting systolic blood pressure =470ms(women) or >=450ms(men) at screening; 15) routine blood test results at screening showed white blood cell count beyond the normal range or platelet count beyond the normal range or hemoglobin level =2×ULN or TBIL>=2×ULN at screening; 17) whose creatinine exceeded the upper limit of normal at screening; 18) abnormal blood K+ and Ca2+ levels at the time of screening, which were judged by the investigators to be clinically significant; 19) fasting blood glucose >=11.1 mmol/L at screening; 20) estimated intraoperative blood loss >500 mL; 21) have active chronic hepatitis B (e.g., hepatitis B surface antigen (HBsAg) positivity and HBV DNA= test) Lower limit], active hepatitis C (e.g., hepatitis C virus (HCV) antibody positive and HCV RNA= the lower limit of detection), human immunodeficiency virus (HIV) antibody positive or active syphilis infection (syphilis-specific antibody positive and syphilis-nonspecific antibody positive); 22) pregnant or lactating female subjects; 23) who participated in other drug/device clinical trials and used the investigational drug/device within 3 months before the administration of the investigational drug/device; 24) were deemed by the investigator to have other factors that precluded participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Heart rate;Area under the time curve for the difference between heart rate at 15 min after the end of the dose and baseline heart rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate and dosage of atropine sulfate used as rescue therapy within 15 min after the end of administration; | — |
Countries
China
Contacts
Public ContactWen Ouyang / Saiying Wang
The Third Xiangya Hospital of Central South University
Outcome results
None listed