Trial to Assess the Efficacy and Safety During Convective Radiofrequency Water Vapor Thermal Therapy (REZUM) for Benign Prostate Hyperplasia

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Methoxyflurane - Penthrox
  Penthrox is a brand name for a drug called methoxyflurane. It is an inhaled analgesic (pain-relieving) agent used primarily for the relief of moderate to severe pain, typically in emergency medical situations or during minor medical procedures. Penthrox is administered by inhaling the vapors through a hand-held inhaler device. It acts quickly to provide pain relief and has a relatively short duration of action.
• Другое Control
  This intervention will be the control group only, receiving deep IV sedation.
• Препарат Percocet Pill
  Percocet will be given in conjunction with methoxyfluorane and lorazepam
• Препарат Lorazepam (drug)
  Lorazepam will be given in conjunction with penthrox and percocet.

Первичные конечные точки

• Post-Procedural Pain [Срок оценки: Immediately post-procedure]

Вторичные конечные точки (4)

• Safety of Procedure [Срок оценки: At time of procedure and post-procedure]
• Cost-effectiveness, [Срок оценки: 1 month post-procedure]
• Anxiety levels [Срок оценки: Pre-Procedure on day of procedure]
• Patient satisfaction [Срок оценки: Immediately post-procedure]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Men's Health Clinic Manitoba — Winnipeg

Идентификаторы

NCT: NCT07017452 · HS27031

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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