Comparing the Efficacy of Epinephrine Nasal Drops and Oxymetazoline Nasal Drops in Reducing Epistaxis During Nasal Intubation: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Epistaxis
研究概览
简要总结
Epistaxis is the most common complication of nasotracheal intubation. Incidence of epistaxis during nasotracheal intubation ranges from 22% to 80%. Epistaxis during nasotracheal intubation can lead to several complications such as nasal discomfort, airway obstruction, and blood aspiration. The most commonly used and available topical vasoconstrictor in drop form is oxymetazoline. However, oxymetazoline may not always be available in some hospitals, so epinephrine can be used as an alternative nasal decongestant to reduce the incidence of epistaxis during nasotracheal intubation.
详细描述
Epistaxis associated with nasotracheal intubation can be from blood-tinged mucus to massive bleeding. Epistaxis during nasotracheal intubation can cause excessive force during the procedure, use of an endotracheal tube (ETT) larger than the nasal cavity, repeated intubation attempts, and abnormalities in the anatomy of the nose or nasopharynx. Epistaxis during nasotracheal intubation can lead to several complications such as nasal discomfort, airway obstruction, and blood aspiration.
Topical vasoconstrictors such as oxymetazoline are used to reduce the incidence and severity of epistaxis caused by nasotracheal intubation. Oxymetazoline nasal drops before nasotracheal intubation significantly increases the intranasal diameter and causes vasoconstriction of blood vessels, thereby reducing bleeding and damage to the nasal mucosa.
Epinephrine can be used as an alternative nasal decongestant to reduce the incidence of epistaxis during nasotracheal intubation. Administering 1 mL of 0.1% topical epinephrine reduces 25% nasal mucosal volume and decreases 37% blood flow, thereby providing nasal cavity expansion with lower hemodynamic and systemic effects.
Currently, there exists a lack of empirical research regarding the utilization of epinephrine drops for the prophylaxis of epistaxis in the context of nasotracheal intubation. Given this gap in the literature, the objective of this investigation is to conduct a comparative analysis between the application of 0.1% epinephrine nasal drops and 0.05% oxymetazoline nasal drops for the prevention of epistaxis during nasotracheal intubation procedures for oral surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •underwent oral surgery with nasotracheal intubation
- •aged 18-50 years
- •ASA (American Society of Anesthesiologists) physical status of 1-2.
排除标准
- •allergy to the medications used
- •nasal congestion, nasal polyps, allergic rhinitis
- •hypertension and use of antihypertensive medications,
- •abnormal coagulation factors, receiving antithrombotic and anticoagulant therapy,
- •difficult intubation with a LEMON score ≥4,
- •a history of nasal surgery or nasal trauma,
- •pregnancy,
- •heart abnormalities,
- •ischemic heart disease or arrhythmias,
- •symptoms of acute respiratory infection perioperatively,
- •liver and kidney function abnormalities, and
- •a history of spontaneous epistaxis
研究组 & 干预措施
epinephrine nasal drops
twenty patients was be administered randomly 1 mL of 0.1% epinephrine nasal drops.
干预措施: epinephrine nasal drops (Drug)
oxymetazoline nasal drops
twenty patients was be administered randomly receives 1 mL of 0.05% oxymetazoline nasal drops
干预措施: oxymetazoline nasal drops (Drug)
结局指标
主要结局
Epistaxis
时间窗: 2 hour
The level of epistaxis was assessed during laryngoscopy intubation, 10 minutes after intubation using laryngoscopy, and immediately after extubation. The degree of epistaxis was graded on 4 levels: None: no bleeding on the posterior pharyngeal wall at the time of intubation and 10 minutes after intubation, and no bleeding from the nasal cavity after extubation. Mild: bleeding on the posterior pharyngeal at intubation, no bleeding in the posterior wall of the pharynx 10 minutes after intubation, and no bleeding from the nasal cavity at extubation (bleeding occurs at only one of these times). Moderate: bleeding on the posterior pharyngeal at the time intubation and 10 minutes after intubation, but no bleeding from the nasal cavity at extubation (bleeding occurs at two of these times). Severe: bleeding on the posterior pharyngeal at the time intubation, 10 minutes after intubation, and bleeding from the nasal cavity at extubation (bleeding occurs at all three times).
次要结局
- Hemodynamic variables(2 hour)
- heart rate (bpm)(2 hour)