Trial to Assess the Efficacy and Safety During Convective Radiofrequency Water Vapor Thermal Therapy (REZUM) for Benign Prostate Hyperplasia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Methoxyflurane - Penthrox, Control, Percocet Pill, Lorazepam (drug).
- Who it may be relevant to
- Registry conditions: Benign Prostate Hypertrophy(BPH). Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
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.
Interventions
- Drug 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. - Other Control
This intervention will be the control group only, receiving deep IV sedation. - Drug Percocet Pill
Percocet will be given in conjunction with methoxyfluorane and lorazepam - Drug Lorazepam (drug)
Lorazepam will be given in conjunction with penthrox and percocet.
Primary outcome measures
- Post-Procedural Pain [Time frame: Immediately post-procedure]
Secondary outcome measures (4)
- Safety of Procedure [Time frame: At time of procedure and post-procedure]
- Cost-effectiveness, [Time frame: 1 month post-procedure]
- Anxiety levels [Time frame: Pre-Procedure on day of procedure]
- Patient satisfaction [Time frame: Immediately post-procedure]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Men's Health Clinic Manitoba — Winnipeg
Identifiers
NCT: NCT07017452 · HS27031