A Pilot Study to Assess Efficacy and Safety of Methoxyflurane for Pain Control During Convective Thermal Therapy Using Rezūm System in Benign Prostatic Hyperplasia (BPH)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Pain intensity
研究概览
简要总结
Open-labeled, single-centre study
详细描述
Patients who have elected Convective Thermal Therapy using Rezūm System for the management of their BPH and fulfilled inclusion and exclusion criteria will sign informed consent form for the study. Patient will use Methoxyflurane inhaler (Penthrox™) on top of standard oral analgesia including oral lorazepam, oral Percocet® (oxycodone and acetaminophen) or oxycodone immediate-release, and intra-urethral lidocaine gel (Xylocaine®). Intravenous propofol will be used as rescue analgesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male subjects of ≥ 18 years of age
- •Patient who has elected Convective Thermal Therapy using Rezūm System for the management of their benign prostatic hyperplasia.
- •No contra-indication on using Methoxyflurane inhaler (Penthrox™).
- •Willing and able to accurately complete the required questionnaires.
- •Willing and able to provide signed and dated informed consent.
排除标准
- •Ongoing use of analgesic agents for chronic pain.
- •Concomitant use of nephrotoxic agents.
- •Use of Methoxyflurane inhaler (Penthrox™) within the previous 3 months.
- •Known allergy to Lorazepam, Percocet/ Oxycodone, or Xylocaine® gel.
- •Known personal or familial hypersensitivity to Methoxyflurane inhaler (Penthrox™) or other halogenated anesthetics.
- •Clinically significant respiratory depression, cardiovascular instability, renal or hepatic impairment.
- •An altered level of consciousness, due to any cause, including head injury, drugs, or alcohol.
- •Known or genetically susceptible to malignant hyperthermia or a history of severe adverse reactions in either patient or relatives.
- •A history of liver dysfunction after previous Methoxyflurane inhaler (Penthrox™) use or other halogenated anesthetics.
研究组 & 干预措施
Penthrox
methoxyflurane inhaler (Penthrox) to be used 5 minutes (+/- 1 minutes) before procedure, and continuously breathing in the inhaler throughout the procedure.
干预措施: Methoxyflurane (Drug)
结局指标
主要结局
Pain intensity
时间窗: immediately after final injection of Rezūm treatment
Visual Analog Scale (VAS) from the range of 0-10 (0 represents no pain, 10 represents maximum pain)
次要结局
未报告次要终点
研究者
Dean Elterman
Clinician Investigator/ Urologist
Can-Am HIFU Inc.