Urinary stone disease is globally prevalent with rising incidence and recurrence, imposing heavy socioeconomic burdens. Flexible ureteroscopy has advanced stone treatment. Single-use flexible ureteroscopes (su-fURS) combined with negative pressure ureteral access sheath (NPUAS), recommended by urology guidelines, improve surgical safety and stone-free rates and can treat stones ≤3 cm. However, su-fURS has poorer image quality, bleeding during lithotripsy may blur vision, frequently impairing efficiency and safety.
Norepinephrine (NE), a tyrosine-derived sympathomimetic amine, mainly activates α1 and β1 receptors. Doses above 3 μg/min trigger predominant α1-mediated vasoconstriction of arteries and veins. It can act on mucosal surfaces via irrigation fluid, making it favorable for initial hemostasis of injured mucosa. Firstly, this study aims to evaluate the efficacy and safety of low-concentration norepinephrine (NE) irrigation solution for hemostasis during lithotripsy performed with single-use flexible ureteroscope (su-fURS) combined with NPUAS, fifteen subjects will be enrolled in the study. Secondly, we explore the dose-effect relationships of four concentrations: 2 mg/3 L, 4 mg/3 L, 6 mg/3 L and 8 mg/3 L, and determine the optimal concentration by comprehensively evaluating hemostatic efficacy and safety. A total of 40 subjects will be enrolled, with 10 subjects in each concentration.
Age 18-75 years of either sex.
Clinically and radiologically confirmed renal or upper-ureteral stone with operative indication for super flexible ureteroscopic lithotripsy combined with negative pressure ultrasound lithotripsy (su-fURS + NPUAS).
Subjects with definite surgical indication for upper urinary tract stones, tolerate general anesthesia, and agree to receive the targeted operative procedure.
Diagnosis of non-upper urinary tract stones.
Intolerance to flexible ureteroscopic surgery.
Poorly-controlled hypertension with blood pressure greater than 160/100 mmHg.
History of coronary artery disease.
Single group
Using irrigation fluid with a certain concentration of norepinephrine
Drug1. Treat with 4 mg/3 L norepinephrine (NE) irrigation fluid during su-fURS combined with NPUAS lithotripsy. 2. Treat with different concentrations of norepinephrine irrigation fluid (2 mg/3 L, 4 mg/3 L, 6 mg/3 L, 8 mg/3 L) when lithotripsy.
Hemoglobin concentration in irrigation fluid
Collect irrigation fluid samples before and after norepinephrine irrigation treatment, and measure the hemoglobin concentration in the irrigation fluid.
Systolic blood pressure (SBP)
After treatment with NE irrigation fluid. Systolic blood pressure was obtained from anesthesia records.
Mean arterial pressure (MAP)
After treatment with NE irrigation fluid. Mean arterial pressure (MAP) was obtained from anesthesia records
Heart rate (HR)
After treatment with NE irrigation fluid. Heart rate (HR) was obtained from anesthesia records.
Safety-related discontinuation proportion (SRD)
The proportion of participants whose study intervention is prematurely terminated because of safety-related adverse events or safety concerns.
Concomitant medications(CMs)
Record the type, dosage, route, and duration of all concomitant medications administered to participants during the study, including medications for underlying diseases, peri-operative supportive drugs and rescue medications.
Incidence of adverse events（IAEs）
Incidence of all-cause adverse events occurring in participants after study, including peri-operative complications and post-operative adverse events.
Stone clearance rate(SCR)
Proportion of participants achieving stone-free status, defined as no residual stones or residual stone fragments ≤2 mm on postoperative imaging examination.
Click on the lead sponsor to view all of their trials.
