About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Methoxyflurane - Penthrox
- Control
- Percocet Pill
- Lorazepam (drug)