Methoxyflurane + Lorazepam + Percocet (Per os) vs Deep Intravenous Sedation: A Non-inferiority Randomized Controlled Trial to Assess the Efficacy and Safety During Convective Radiofrequency Water Vapor Thermal Therapy (REZUM) for Benign Prostate Hyperplasia
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Post-Procedural Pain
研究概览
简要总结
The primary aim of the study is to show that methoxyflurane-lorazepam-percocet combination administrated 'per os' is non inferior to deep intravenous sedation in achieving analgesia during Rezum convective radiofrequency water vapor thermal therapy for the management of benign prostate hyperplasia (BPH). We propose to conduct a single-centered, unblinded, randomized controlled trial designed after consulting ICH Guidelines for Good Clinical Practice as well the regulations set by the Biomedical Research Ethics Board, University of Manitoba.
详细描述
Participants who belong to the experimental arm will be given a single 'per os' dose of percocet (325mg acetaminophen + 7.5mg oxycodone) and lorazepam 1 mg, 30 minutes prior to the procedure. Patients will receive education on how to use the Penthrox inhaler device. Inside the operating room, the subject would self-inhale the methoxyflurane 5 minutes prior to the procedure. All these steps will be supervised by the clinical research nurse. Each participant will be administered with 3ml of methoxyflurane which is poured into the inhaler. Participants who were randomized to the control arm will receive deep intravenous sedation under the supervision of a trained anesthetist. A combination of midazolam, ketamine, remifentanil and propofol will be administered using an intravenous line. The quantity of these medications will be calculated by the anesthetist based on clinical judgement and also takes into account the physical characteristic of the subject. Both the groups receive the same Rezum water vapor therapy and the number of Rezum injections depends on the clinical judgement of the urologist performing the procedure. Immediately, post the procedure, the self-reported pain of the patient will be recoded using the NRS. A phone call follow-up would be done the following day to record any adverse events caused due to the procedure. Four weeks post the procedure, a phone call follow-up would be done to understand the patient satisfaction after the surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Able to provide an informed consent.
- •Age ≥ 18 years
- •Biological males identified with male sexual organs.
- •Scheduled for convective radiofrequency water vapor thermal therapy (REZUM) for the management of benign prostate hyperplasia.
排除标准
- •Concomitant use of nephrotoxic and/or hepatoxic agents.
- •Use of ≥ 6 ml Penthrox withing the previous 3 weeks.
- •Known allergies and/or adverse events due to penthrox, other halogenated anesthetics, percocet (oxycodone + acetaminophen), lorazepam, lidocaine, midazolam, ketamine, remifentanil and propofol
- •History of genetic susceptibility to malignant hyperthermia.
- •Presence of clinically significant respiratory depression, cardiovascular instability, renal or hepatic impairment
- •Altered level of consciousness due to any cause.
研究组 & 干预措施
Intervention arm-Penthrox
Participants can begin using penthrox 10 minutes prior to procedure start, given its median onset time of 5 minutes
干预措施: Lorazepam (drug) (Drug)
Intervention arm-Penthrox
Participants can begin using penthrox 10 minutes prior to procedure start, given its median onset time of 5 minutes
干预措施: Methoxyflurane - Penthrox (Drug)
Intervention arm-Penthrox
Participants can begin using penthrox 10 minutes prior to procedure start, given its median onset time of 5 minutes
干预措施: Percocet Pill (Drug)
Control arm
Patients will receive standard of care during their rezum procedure which consists of deep IV sedation.
干预措施: Control (Other)
结局指标
主要结局
Post-Procedural Pain
时间窗: Immediately post-procedure
Post procedural pain measured using the Numeric Rating Scale for pain. Higher scores on this measurement indicate worser outcomes. Maximum value of 10 and a minimum value of 10 can be reported on this scale.
次要结局
- Cost-effectiveness,(1 month post-procedure)
- Safety of Procedure(At time of procedure and post-procedure)
- Anxiety levels(Pre-Procedure on day of procedure)
- Patient satisfaction(Immediately post-procedure)
研究者
Premal Patel, MD
Assistant Professor, Department of Surgery. Director, Undergraduate Urologic Medical Education
University of Manitoba
