Tachyarrhythmia
Conditions
Interventions
Experimental group:Landiolol hydrochloride was infused intravenously
Control group:Placebo was administered intravenously
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) fully understand and voluntarily participate in the trial, and sign the informed consent; (2) 18 years old =70 years old, regardless of gender; (3) 18kg/m2=BMI=30kg/m2; (4) elective surgery under general anesthesia; (5) subjects with American Society of Anesthesiologists (ASA) grade ?-III; (6) Able to understand the trial process and communicate effectively with researchers.
Exclusion criteria
Exclusion criteria: (1) patients with known allergies to or contraindications to ß1 blockers such as landiolol, esmolol, and other drugs that may be used during the trial; (2) long-term users or patients treated with tricyclic or tetracyclic antipsychotics, ß-blockers, diuretics, or a-blockers within 1 week before randomization; (3) patients with any of the following clinically severe past history or current serious medical conditions that could affect the trial as determined by the investigator: 1) Circulatory system diseases: Patients with unstable angina pectoris and/or acute myocardial infarction within the last month, congestive heart failure (according to the New York Heart Association [NYHA] classification ?-?), cardiac insufficiency caused by pulmonary arterial hypertension, cardiogenic shock, complicated with more than II degree atrioventricular block, sick sinus syndrome and other bradycardia arrhythmia; Or peripheral circulation disorders (such as gangrene, Raynaud's syndrome, intermittent claudication, etc.), previous bleeding or dehydration caused by circulatory blood volume reduction, and failed to correct in time; 2) endocrine system diseases: patients with diabetic ketosis or metabolic acidosis (except those judged only by blood gas indexes during previous surgery); 3) patients with mental disorders (such as schizophrenia, mania, psychosis, etc.) or cognitive impairment; 4) Severe blood system diseases, such as leukemia, myelofibrosis, aplastic anemia, coagulation factor deficiency or other coagulation index disorders caused by bleeding diseases; 5) patients with craniocerebral injury, possibly with increased intracranial pressure, cerebral aneurysm, history of cerebrovascular accident or other central nervous system diseases; 6) patients with elevated intraocular pressure (such as glaucoma) or a history of ocular puncture trauma; 7) history of bronchospasm; 8) with prior untreated pheochromocytoma. (4) patients with pacemaker before screening; (5) Abnormal examination results in the screening period and judged to be clinically significant: 1) If blood glucose was poorly controlled, random blood glucose =11.1mmol/L after drug treatment; 2) If blood pressure was poorly controlled, after drug treatment, the sitting systolic blood pressure during screening period was < 90mmHg and/or =160 mmHg, and/or the sitting diastolic blood pressure during screening period was =100mmHg; 3) abnormal liver and renal function: aspartate aminotransferase (AST) =1.5×ULN; Alanine aminotransferase (ALT) =1.5×ULN; Total bilirubin (TBIL) =1.5×ULN; Serum creatinine (Cr) =1.5×ULN; 4) severe bradycardia, as assessed by the investigator. (6) Syphilis antibody and human immunodeficiency virus (HIV) antibody were positive during the screening period; (7) pregnant or lactating women; If the subjects are of childbearing potential, have plans to have children, donate eggs, or are unwilling or unable to use effective contraception during the trial and 3 months (90 days) after the end of the trial; (8) patients who participated in clinical trials of other drugs or devices and received treatment within 30 days before screening; And (9) any other circumstances that the investigator considered inappropriate to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective rate of tachycardia control at 11 minutes after initiation of dosing; | — |
Secondary
| Measure | Time frame |
|---|---|
| Effective rate of tachycardia control per minute;The incidence of rescue use;Onset time (the onset time was defined as the time when the first heart rate decreased by 10% from the baseline value);The change of heart rate systolic blood pressure product (RPP) from baseline; | — |
Countries
China
Contacts
Public ContactWen Ouyang / Saiying Wang
The Third Xiangya Hospital of Central South University
Outcome results
None listed