Tachyarrhythmia
Conditions
Interventions
Trial group:Landiolol hydrochloride is administered by intravenous infusion at a rate of 0.125 mg/kg/min for 1 minute, followed by 0.04 mg/kg/min for another 1 minute
if the heart rate decreases by >=10% compared to baseline within 2 minutes after the start of infusion (observation time =10% compared to baseline within 2 minutes after the start of infusion (observa
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–65 years, either sex, BMI 18–30 kg/m^2 (both cutoff values included); 2. Patients undergoing elective surgery under general anesthesia; 3. ASA anesthesia classification grade 1–3; 4. Subjects fully understood the trial content and potential adverse reactions, voluntarily participated in the study, provided written informed consent, and were able to comply with all procedures specified in the study protocol.
Exclusion criteria
Exclusion criteria: 1. Subjects with known allergies to or contraindications to ß1 blockers such as landiolol or esmolol and other drugs that may be used during the trial; 2. Circulatory system diseases: (1) Patients with coronary heart disease, unstable angina pectoris, and/or acute myocardial infarction in the past 1 month; (2) Patients with congestive heart failure (New York Heart Association [NYHA] functional class III–IV); (3) Patients with cardiac insufficiency caused by pulmonary hypertension; (4) Patients with cardiogenic shock; (5) Patients with second-degree or higher atrioventricular block, sick sinus syndrome, or other clinically significant bradycardic arrhythmias; (6) Patients with peripheral circulatory disorders (e.g., gangrene, Raynaud’s syndrome, intermittent claudication); (7) Patients with prior significant blood loss or dehydration leading to reduced circulatory blood volume that has not been adequately corrected; 3. Patients with endocrine system diseases, such as diabetic ketoacidosis, hyperthyroidism, or metabolic acidosis (excluding cases diagnosed solely based on perioperative blood gas analysis); 4. Patients with pheochromocytoma; 5. Patients with mental system disorders (e.g., schizophrenia, mania, delirium) or cognitive impairment; 6. Patients with craniocerebral injury, elevated intracranial pressure, cerebral aneurysm, history of stroke, or other clinically significant central nervous system diseases; 7. Patients with ocular conditions such as elevated intraocular pressure or penetrating ocular trauma; 8. Patients with bronchospasm or severe chronic obstructive pulmonary disease (COPD); 9. Patients who have taken tricyclic or tetracyclic psychotropic drugs, ß-blockers, diuretics, or a-blockers within one week prior to the trial; 10. Patients with clinically significant abnormal findings during screening: (1) Inadequately controlled blood glucose: random blood glucose >=11.1 mmol/L despite pharmacological treatment; (2) Inadequately controlled blood pressure: after pharmacological treatment, sitting systolic blood pressure =140 mmHg, and/or sitting diastolic blood pressure >=90 mmHg during screening; (3) Severe hepatic or renal disease or dysfunction: ALT or AST >2.5× upper limit of normal (ULN), TBIL >2× ULN, or Cr >1.5× ULN; (4) Severe bradycardia as assessed by the investigator; 11. Pregnant or lactating women, or patients planning pregnancy within 3 months after administration; 12. Patients who have participated in another clinical trial within the past 6 months; 13. Subjects deemed unsuitable for participation in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with effective control of tachycardia at 11 minutes after the start of dose administration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to onset;Effective rate of tachycardia control per minute from the beginning of dosing to the end of dosing;Proportion of subjects who used at least one rescue medication from the start of dosing until the end of dosing;Change in the heart rate systolic blood pressure product (RPP) from baseline at 11 minutes after the start of dosing;Proportion of patients with effective control of tachycardia in both groups at 2 hours after the end of dosing;The proportion of patients whose heart rate was adjusted to 60-100 beats 24-48 hours after operation in both groups; | — |
Countries
China
Contacts
Public ContactWang Saiying / Ouyang Wen
The Third Xiangya Hospital of Central South University
Outcome results
None listed