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临床试验/NCT05649020
NCT05649020招募中4 期

ED50 of Intrathecal Hyperbaric 2% Prilocaine in Transperineal Magnetic Resonance Imaging-Transrectal Ultrasound Fusion Guided Biopsy

Hospital General Universitario Gregorio Marañon1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年11月24日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
90
试验地点
1
主要终点
ED50 of intrathecal hyperbaric 2% prilocaine in transperineal magnetic resonance imaging-transrectal ultrasound fusion guided biopsy

研究概览

简要总结

The aim of the present study was to determine the ED50 and ED90 of intrathecal hyperbaric 2% prilocaine (HP) for patients undergoing ambulatory prostate biopsy via magnetic resonance imaging (MRI)/ultrasound fusion.

详细描述

Prostate biopsy to diagnose or exclude cancer is currently performed an estimated one million times annually worldwide. In this method, the operator images the prostate using ultrasound, as performed for the past several decades; while thus viewing the prostate, the MRI of that prostate, which is performed beforehand and stored in the device, is fused with real-time ultrasound using a digital overlay, allowing the target(s), previously delineated by a radiologist, to be brought into the aiming mechanism of the ultrasound machine. The fusion results in creation of a three-dimensional reconstruction of the prostate, and on the reconstructed model, the aiming and tracking of biopsy sites occurs. This method needs for sedation/general/ spinal anesthesia because of patient discomfort with the transperineal approach of the biopsy needle passing through the perineum.

Even though the MRI/ultrasound fusión prostate biopsy is widespread used, the anaesthetic techniques for this procedure are not standardised. Hyperbaric prilocaine is an amide-type local anesthetic widely used in short surgical procedures showing its efficacy for outpatient surgery. The proposed intrathecal doses of prilocaine for various surgical procedures range from 10 to 80 mg. Thus, even though the drug is in clinical use, optimal doses of HP required for specific types of surgery warrant further refinement. The aim of the present study was to determine the ED50 and ED90 of intrathecal HP for patients undergoing undergoing ambulatory MRI/ultrasound fusión prostate biopsy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
主要目的
Other
盲法
None

盲法说明

The nurse blinded to the dose, was absent during the procedure and assessed each block. Furthermore, all patients were unaware of the injected dose of HP.

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • ASA II-III patients Aged 18-85 years Prostate fusion biopsy procedure Scheduled to ambulatory surgery Signed informed consent

排除标准

  • Standard contraindications to neuraxial blockade, coagulopathy, site infection, neurological impairment, known allergy to local anesthetics. Refusal of the patient to participate in the study.

研究组 & 干预措施

Prilocaine dose

Other

to determine the ED50 and ED90 of intrathecal HP for patients undergoing undergoing ambulatory MRI/ultrasound fusión prostate biopsy.

干预措施: Dose of prilocaine (Drug)

结局指标

主要结局

ED50 of intrathecal hyperbaric 2% prilocaine in transperineal magnetic resonance imaging-transrectal ultrasound fusion guided biopsy

时间窗: From the baseline, previous to prilocaine adminstration until the end of the prostate biopsy procedure. 30 minutes

to determine the ED50 and ED90 of intrathecal HP for patients undergoing undergoing ambulatory MRI/ultrasound fusión prostate biopsy.

次要结局

  • acute urinary retention(From the baseline previous to prilocaine adminstration until the first 24 hours after the prostate biopsy procedure)
  • incidence of unplanned admissions(From the baseline previous to prilocaine adminstration until the first 24 hours after the prostate biopsy procedure)
  • length of stay in the facility(From the baseline previous to prilocaine adminstration until the patient meets discharge criteria, defined by complete regression of sensory block.)
  • To analyze the hemodynamic response during surgery(From the baseline previous to prilocaine adminstration until the end of the prostate biopsy. 30 minutes)

研究者

发起方
Hospital General Universitario Gregorio Marañon
申办方类型
Other
责任方
Principal Investigator
主要研究者

Matilde Zaballos

Professor

Hospital General Universitario Gregorio Marañon

研究点 (1)

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