Brimonidine for Intraoperative Hemostasis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-26

Study Completion Date

2024-05-22

Brief Summary

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The purpose of this study is to observe and report the effects of topical ophthalmic brimonidine in oculofacial plastic surgery.

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Detailed Description

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Brimonidine ophthalmic solution (Alphagan) is mainstay in glaucoma therapy to reduce intraocular pressure. The medication is an alpha2 adrenergic agonist, which increases uveoscleral outflow of aqueous humor. Alpha2 agonists also have vasoconstrictive properties, which has been utilized in over-the-counter medications like Lumify for redness relief. An unexploited utility of its vasoconstrictive property is reduction in intraoperative bleeding during ophthalmic surgery. The purpose of this study is to observe and report the effects of brimonidine in oculofacial plastic surgery.

There are reports in ophthalmic literature that observe the hemostatic effect of topical brimonidine across different subspecialties. It has been shown to reduce intraoperative bleeding and post-operative subconjunctival hemorrhages in pterygium removal, strabismus surgery, LASIK, and cataract surgery. One study claimed that it had a comparable hemostatic effect to phenylephrine.

Many of the procedures in oculoplastic surgery involve manipulation and incision of eyelid skin and conjunctival tissue. Some examples include blepharoplasty, ptosis repair, medial spindles, lateral tarsal strips, canthotomy and cantholysis with subsequent repair, retraction repair, and orbital fracture repair. Rapid and adequate control of intraoperative bleeding is crucial to the success of oculoplastic surgery. Although surgeons take proper precautions to prevent inadequate hemostasis (discontinuing blood thinners, use of electrocautery, and administration of intradermal epinephrine), excessive bleeding can still occur. This can impair surgeon performance by obscuring visualization, and negatively affect the patient due to prolonged operative times, and delayed healing due to hematoma formation. The most feared complication of oculoplastic surgery is intraorbital hemorrhage, which can cause orbital compartment syndrome causing vision loss.

Therefore, any intervention to minimize bleeding is very advantageous to the patient. Use of Brimonidine drops intraoperatively will improve hemostasis, resulting in improved visualization, reduced operative time under anesthesia, and reduced risk of significant intraorbital hemorrhage. Due to both brimonidine's vasoconstrictive properties and relatively favorable safety profile, it raises the question: can brimonidine be used to achieve better hemostasis in oculoplastic procedures?

Conditions

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Dermatochalasis of Eyelid Ptosis, Eyelid Ectropion Entropion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized, prospective clinical trial will be performed with IRB approval to compare intraoperative application of ophthalmic brimonidine solution to standard methods of hemostasis control. This study will be blinded to the surgeon grading the severity of bleeding and the patient unaware which side would receive the intervention. Topical brimonidine ophthalmic solution will be placed intraoperatively to the open surgical wound of one eyelid and we will assess the severity of bleeding via a surgeon's grading scale. The fellow eye's surgical wound will be used as the control. The laterality of intervention is randomized. Reduction of bleeding severity is the primary outcome as graded by a subjective surgeon's grading scale. A secondary outcome may be severity of postoperative bruising in the study eye versus the fellow control eye, as graded by post-operative bruising severity.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

This study will be blinded to the surgeon grading the severity of bleeding and the patient will be unaware which side would receive the intervention.

Study Groups

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Brimonidine intervention

We will compare hemostasis between 2 surgical sides of the same patient. One side will be randomized to receive Brimonidine (0.15% or 0.2%) in addition to standard hemostasis measures, while the other side will receive only standard hemostasis measures (preoperative discontinuation of blood thinners, preoperative injection of lidocaine with epinephrine).

Group Type EXPERIMENTAL

Brimonidine Topical

Intervention Type DRUG

Topical brimonidine intraoperatively for hemostasis

Control Arm

We will compare hemostasis between 2 surgical sides of the same patient. One side will be randomized to receive Brimonidine (0.15% or 0.2%) in addition to standard hemostasis measures, while the other side will receive only standard hemostasis measures (preoperative discontinuation of blood thinners, preoperative injection of lidocaine with epinephrine).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Brimonidine Topical

Topical brimonidine intraoperatively for hemostasis

Intervention Type DRUG

Other Intervention Names

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Alphagan

Eligibility Criteria

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Inclusion Criteria

* Above the age of 18
* Ophthalmic conditions requiring oculoplastic surgery

Exclusion Criteria

* Known allergy or adverse effects to brimonidine
* Hypotony
* Acute ophthalmic infection
* History of hypotension
* Orthostatic hypotension
* Pregnancy
* History of Central Nervous System (CNS) depression from medication use
* Thrombotic disorders
* Asymmetrical oculoplastic conditions that may interfere with tear drainage (e.g. unilateral NLDO)
* Current use of brimonidine

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes