Efficacy of Intraoperative Brimonidine for Hemostasis During Eyelid Surgery
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Hemostasis
研究概览
简要总结
The purpose of this study is to observe and report the effects of topical ophthalmic brimonidine in oculofacial plastic surgery.
详细描述
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?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Above the age of 18
- •Ophthalmic conditions requiring oculoplastic surgery
排除标准
- •Known allergy or adverse effects to brimonidine
- •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
研究组 & 干预措施
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).
干预措施: Brimonidine Topical (Drug)
结局指标
主要结局
Hemostasis
时间窗: At the time of surgery.
Change in Hemostasis Score
次要结局
未报告次要终点
研究者
Christopher James Compton
Associate Professor
University of Louisville
