Brimonidine for Intraoperative Hemostasis

Phase 4

Withdrawn

• Conditions: Ectropion; Dermatochalasis of Eyelid; Ptosis, Eyelid; Entropion
• Interventions: Drug: Brimonidine Topical

• Registration Number: NCT05480098
• Lead Sponsor: University of Louisville

Brief Summary

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

Detailed Description

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?

Study Timeline

• Study Start: 2022-05-26
• Study First Submitted: 2022-06-06
• Study First Submitted QC: 2022-07-27
• Study First Posted: 2022-07-29
• Primary Completion: 2024-05-22
• Study Completion: 2024-05-22
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brimonidine intervention	Brimonidine Topical	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).

Primary Outcome Measures

Name	Time	Method
Hemostasis	At the time of surgery.	Change in Hemostasis Score

Trial Locations

Locations (1)

University of Louisville; 🇺🇸 Louisville, Kentucky, United States