Lithotripsy, Urolithiasis
Conditions
Brief 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.
Interventions
DRUGUsing 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.
Sponsors
Geriatric Hospital of Nanjing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concomitant medications(CMs) | From initiation of study intervention up to completion of surgical procedure (within-operative period) | 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） | From time of initial intervention through 8 hours post-procedure, assessed up to Post-operative Day 1 | Incidence of all-cause adverse events occurring in participants after study, including peri-operative complications and post-operative adverse events. |
| Stone clearance rate(SCR) | 1 day after surgical procedure | Proportion of participants achieving stone-free status, defined as no residual stones or residual stone fragments ≤2 mm on postoperative imaging examination. |
| Safety-related discontinuation proportion (SRD) | From initiation of study intervention up to completion of surgical procedure (within-operative period) | The proportion of participants whose study intervention is prematurely terminated because of safety-related adverse events or safety concerns. |
Countries
China
Contacts
CONTACTChuang Wu, Doctor of Medicine
Outcome results
None listed