Benign Prostate Hypertrophy(BPH)
Conditions
Brief summary
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
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.
OTHERControl
This intervention will be the control group only, receiving deep IV sedation.
DRUGPercocet Pill
Percocet will be given in conjunction with methoxyfluorane and lorazepam
DRUGLorazepam (drug)
Lorazepam will be given in conjunction with penthrox and percocet.
Sponsors
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single-centered, unblinded, randomized controlled trial. Two arms, one is the intervention arm which will receive Penthrox with a combination of Percocet and Lorazepam. The control arm will receive the standard of care during the rezum procedure which is deep IV sedation.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-Procedural Pain | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Procedure | At time of procedure and post-procedure | The safety of combination vs deep intravenous sedation during Rezum will be measured by accounting for adverse event encountered during the procedure. |
| Cost-effectiveness, | 1 month post-procedure | We will compare the costs associated with the procedure in both arms to see if there is any difference. |
| Anxiety levels | Pre-Procedure on day of procedure | We will measure anxiety levels using the Amsterdam Pre-Operative Anxiety and Information Scale (APAIS). Higher scores indicate worser outcomes. Maximum value of 30 and a minimum value of 0. It is a 6 part questionnaire which each question is given on a likert scale from 1-5 |
| Patient satisfaction | Immediately post-procedure | We will measure patient satisfaction using a likert scale single question patient satisfaction questionnaire. (higher scores indicate better outcomes). Maximum value of 5 and a minimum value of 0. |
Countries
Canada
Contacts
Primary ContactPremal Patel, MD
Outcome results
None listed