CompletedPhase 4

Preoperative Brimonidine on IOP of Patients Undergoing RALP

Canada26 participantsStarted 2016-02-29

Plain-language summary

Patients with prostate cancer undergoing robot assisted radical laparoscopic prostatectomy (RALP) in steep Trendelenburg position (sTBURG) are noted to have elevated intraocular pressures (IOP) intraoperatively. One study showed an increase in IOP of 13 millimeters of mercury (mmHg) from baseline IOP levels intraoperatively. Other studies have shown the IOP to more than double intraoperatively during RALP in sTBURG. IOP is found to be directly related to angle of inclination and increases time dependently with sTBURG. The IOP may remain significantly elevated until the first postoperative day after RALP. There are no previously published data concerning the safe threshold for IOP elevation and the effects of this increased IOP on vision and on generalized eye health are still not entirely known. One study showed postoperative visual field defects in 28% (7/25) of patients who underwent RALP in sTBURG. It has been theorized that sTBURG and subsequent increased IOP are risk factors for postoperative vision loss (PVL). It is believed that the increased IOP decreases optic nerve perfusion pressure causing ischemic optic neuropathy. Some previously recommended ways to reduce the intraoperative IOP spike during RALP include shorter operating times, decreased angle of inclination, modified Trendelenburg position, use of Propofol for maintenance anaesthesia and intraoperative topical hypotensive agents to reduce IOP. Given the challenges with some of the above options, this study aims to evaluate the effect of pre-operative treatment with topical Brimonidine Tartrate 0.2% on the IOP of patients undergoing RALP with sTBURG. The goal is to prevent the anticipated IOP spike thereby reducing risk of postoperative vision loss.

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Males aged 18 years and above * Patients with a diagnosis of prostatic carcinoma requiring prostate surgery Exclusion Criteria: * Patients having had an ophthalmic surgical procedure within 6 months of the beginning of the study. * Patients with a diagnosis of glaucoma * Any abnormality of the cornea which may prevent reliable applanation tonometry * Known allergy/ hypersensitivity reaction to Brimonidine * Contra-indication to Brimonidine including patients on monoamine oxidase inhibitors (MOA) * Patients unwilling or unable to provide informed consent * Patients with anticipated difficult airway management (as this may require medications and/or airway manipulations resulting in increased IOP)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in IOP during the course of the surgical procedure between eyes treated with medication and those with placebo with patients undergoing RALP with sTBURG

Timeframe: Preoperatively within 1-2 months, intraoperatively, and postoperatively within 1-2 months

Trial details

NCT IDNCT02818816

SponsorUniversity Health Network, Toronto

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-01-24

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