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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
55
1. 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.
Geriatric Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGHemoglobin concentration in irrigation fluid
Collect irrigation fluid samples before and after norepinephrine irrigation treatment, and measure the hemoglobin concentration in the irrigation fluid.
Time frame: Under identical operating conditions, the irrigation fluid was collected before and 3 minutes after treatment with 4 mg/3 L NE bitartrate irrigation fluid.
Systolic blood pressure (SBP)
After treatment with NE irrigation fluid. Systolic blood pressure was obtained from anesthesia records.
Time frame: Periprocedural
Mean arterial pressure (MAP)
After treatment with NE irrigation fluid. Mean arterial pressure (MAP) was obtained from anesthesia records
Time frame: Periprocedural
Heart rate (HR)
After treatment with NE irrigation fluid. Heart rate (HR) was obtained from anesthesia records.
Time frame: Periprocedural
Safety-related discontinuation proportion (SRD)
The proportion of participants whose study intervention is prematurely terminated because of safety-related adverse events or safety concerns.
Time frame: From initiation of study intervention up to completion of surgical procedure (within-operative period)
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.
Time frame: From initiation of study intervention up to completion of surgical procedure (within-operative period)
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.
Time frame: From time of initial intervention through 8 hours post-procedure, assessed up to Post-operative Day 1
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.
Time frame: 1 day after surgical procedure
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