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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm-Penthrox | Experimental | Participants can begin using penthrox 10 minutes prior to procedure start, given its median onset time of 5 minutes |
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| Control arm | Placebo Comparator | Patients will receive standard of care during their rezum procedure which consists of deep IV sedation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methoxyflurane - Penthrox | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-Procedural Pain | 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. | Immediately post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Procedure | The safety of combination vs deep intravenous sedation during Rezum will be measured by accounting for adverse event encountered during the procedure. | At time of procedure and post-procedure |
| Cost-effectiveness, |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Premal Patel, MD | Contact | 204-221-4476 | ppatel5@hsc.mb.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Men's Health Clinic Manitoba | Winnipeg | Manitoba | R3K 1M3 | Canada |
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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.
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| Control | Other | This intervention will be the control group only, receiving deep IV sedation. |
|
| Percocet Pill | Drug | Percocet will be given in conjunction with methoxyfluorane and lorazepam |
|
| Lorazepam (drug) | Drug | Lorazepam will be given in conjunction with penthrox and percocet. |
|
We will compare the costs associated with the procedure in both arms to see if there is any difference.
| 1 month post-procedure |
| Anxiety levels | 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 | Pre-Procedure on day of procedure |
| Patient satisfaction | 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. | Immediately post-procedure |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C514822 | oxycodone-acetaminophen |
| D008140 | Lorazepam |
| D004364 | Pharmaceutical Preparations |
| ID | Term |
|---|---|
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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