Hemostatic and Hemodynamic Effects of Intranasal Injection Compared to Topical Administration of Epinephrin in Endoscopic Sinus Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Intraoperative hemodynamic alterations (instability)
研究概览
简要总结
Intranasal injection of epinephrine is used routinely during endoscopic sinus surgery (ESS) to reduce bleeding in the nasal mucosa and thereby improve visualization of the surgical field. However, systemic absorption of epinephrine via the nasal mucosa is often accompanied by cardiovascular side effects during the early postinjection period, putting in risk patients with cardiovascular morbidity. Evidence indicate that topical administration of epinephrine achieves similar hemostatic effects compared with injection of epinephrine, while avoiding systemic adverse effects. We wish to conduct a prospective controlled trial assessing the hemostatic and hemodynamic effects of intranasal injection compared to topical application of epinephrin during ESS, in order to evaluate whether the previous could be avoided due to its untoward effects.
We hypothesize that topical administration of epinephrine provides a hemostatic effect not inferior to that of intranasal injection while minimizing hemodynamic instability during ESS.
详细描述
Introduction:
Intranasal injection of epinephrine is used routinely during endoscopic sinus surgery (ESS) to reduce bleeding in the nasal mucosa and hence improve visualization of the surgical field [1, 2].
Systemic absorption of epinephrine via the nasal mucosa, due to its vasoconstriction ability and cardiac effect, is often accompanied by cardiovascular side effects (e.g., hypertension, hypotension, tachycardia, cardiac arrhythmias, etc) during the early postinjection period [1, 3-5]. In patients with minimal cardiac reserve, these acute hyperdynamic effects may result in myocardial ischemia or infarction [6, 7]. The nasal mucosa has an excellent absorbing capability which may be utilized for local administration of vasoconstrictive substances instead of intranasal injection [8, 9], thus avoiding their systemic adverse effects .
Evidence indicate that topical use of epinephrine may achieve similar hemostatic effects compared with injection of epinephrine [10]. Another pilot study has demonstrated that epinephrine injection better facilitates visualization of the surgical field, yet topical application does not involve hemodynamic side effects [11]. However, a prospective, randomized larger trial has shown that, when local anesthetic containing epinephrine was used compared with normal saline (NS) injection for ESS, there was no significant reduction in intraoperative blood loss or duration of surgery. More importantly, a significantly higher mean arterial blood pressure (MABP) was associated with injection of epinephrine [2].
The objective of the current study is to compare the hemostatic and hemodynamic effects of intranasal injection versus topical application of epinephrin during ESS, in order to evaluate whether the previous could be avoided due to its untoward effects.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ASA I-III,
- •Patients undergoing elective FESS at Sourasky Medical Center for Chronic rhinosinusitis with or without polyposis, including FESS combined with septoplasty and/or conchotomy.
排除标准
- •Patients scheduled for endoscopic resection of a tumor or closure of a cerebrospinal fluid leak, and
- •Patients for whom epinephrine was contraindicated.
研究组 & 干预措施
Topical administration
An an intranasal injection of saline will be used as control, and thereafter cotton pledgets soaked in 1 mL epinephrine 1:1,000 will be placed in the nasal cavity during surgery when necessary.
干预措施: Epinephrin (Topical administration) (Drug)
Intranasal injection
An intranasal injection of 8 mL epinephrine 1:100,000 will be performed as traditionally practiced in ESS. Thereafter, cotton pledgets soaked in 1 mL epinephrine 1:1,000 will be placed in the nasal cavity during surgery when necessary.
干预措施: Epinephrin (Intranasal injection) (Drug)
结局指标
主要结局
Intraoperative hemodynamic alterations (instability)
时间窗: duration of surgery
Changes in intraoperative hemodynamic parameters will be monitored continuously,and any event will be documented, including: lowest and highest HR, SP and MAP values; mean HR, SP and MAP during surgery; incidence of hypotensive and hypertensive events (\>20% relative to baseline); incidence of tachycardic (HR\>115) and bradycardic (HR\<55) events.
次要结局
- Hemostasis(duration of surgery)