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临床试验/NCT05480098
NCT05480098撤回4 期

Efficacy of Intraoperative Brimonidine for Hemostasis During Eyelid Surgery

University of Louisville1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年5月26日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christopher James Compton

Associate Professor

University of Louisville

研究点 (1)

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