A Study on the Application of NE Irrigation Fluid for Hemostasis in Flexible Ureteroscopic Lithotripsy: A Prospective Single-arm Interventional Study of Upper Urinary Tract Calculi.(NE: Norepinephrine)

Condition(s) studied

Investigational drug(s) / intervention(s)

Using irrigation fluid with a certain concentration of norepinephrine: 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Hemoglobin concentration in irrigation fluid — Under identical operating conditions, the irrigation fluid was collected before and 3 minutes after treatment with 4 mg/3 L NE bitartrate 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) — Periprocedural
  After treatment with NE irrigation fluid. Systolic blood pressure was obtained from anesthesia records.
• Mean arterial pressure (MAP) — Periprocedural
  After treatment with NE irrigation fluid. Mean arterial pressure (MAP) was obtained from anesthesia records
• Heart rate (HR) — Periprocedural
  After treatment with NE irrigation fluid. Heart rate (HR) was obtained from anesthesia records.

Trial sites (1)

Other trials for the same condition