Pre-emptive Epinephrine Nebulization Prior to Nasotracheal Intubation for Mandibular Fracture Fixation Surgeries:Dose it Really Differs? a Randomized Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- estimate the degree of epistaxis
研究概览
简要总结
This randomised, prospective study performed in Ain shams university hospitals over 126 Patients ASA I and ASA II, trauma patients who suffered isolated mandibular fractures and necessitated nasal intubation during general anesthesia. The patients were randomly assigned to one of two equal groups: nasal Lidocaine drops followed by Oxymetazoline nasal drops group (OL) or Epinephrine mixed with Lidocaine as nebulization session (EL) group.
详细描述
One group received epinephrine mixed with lidocaine as nebulization session (EL group) and the other group received nasal lidocaine drops followed by Oxymetazoline nasal drops group (OL). Before the preparation of the airway, we examined the nasal cavity by using a light source to select the target nostril; if we could not determine, we chose the right nostril. No premedication was administered.
Group (EL) (63 patients) received a session of nebulization in the pre-induction area, consisting of 1 ml epinephrine (1:1000 Martindale Pharma, an Ethypharm Group Company, ampoule 1 mg added to 9 ml of normal saline, then 1 ml of that put in nebulization cup + 2 ml lidocaine 2%), nebulized prior to the induction of anesthesia.
Group OL (63 patients): These patients received five drops of lidocaine hydrochloride (Xylocaine 2%, 20 mg/ml; AstraZeneca, London, UK) using a prefilled dropper, followed by six drops of hydrochloride Oxymetazoline (Otrivin adult nasal drops 0.1%, 10 ml of 1 mg/ml; Novartis Consumer Health, UK Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, UK) in each nostril in the
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
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cases with American Society of Anesthesiologists (ASA) classes I and II.
- •Patients scheduled for elective oral isolated mandibular fracture fixation requiring nasotracheal intubation.
排除标准
- •Nasal abnormality history (such as polyp , surgery or nasal trauma).
- •Frequent epistaxis history.
- •Patients suffering valvular heart disease, hypertension, ischemic heart disease or arrhythmias.
- •Patients using drugs (anticoagulation therapy, non-steroidal anti-inflammatory drugs, and oral decongestants).
- •Patients receiving medications known to alter the parameters under investigation including β-blockers, calcium channel blockers, or vasodilators.
- •Patients known to have hypersensitivity to medications used in this study.
研究组 & 干预措施
Group (EL) Epinepherine and Lidocaone group
Group (EL) (63 patients) received a session of nebulization in the pre-induction area, consisting of 1 ml epinephrine (1:1000 Martindale Pharma, an Ethypharm Group Company, ampoule 1 mg added to 9 ml of normal saline, then 1 ml of that put in nebulization cup + 2 ml lidocaine 2%), nebulized prior to the induction of anesthesia.(63 patients) received a session of nebulization in the pre-induction area, consisting of 1 ml epinephrine (1:1000 Martindale Pharma, an Ethypharm Group Company, ampoule 1 mg added to 9 ml of normal saline, then 1 ml of that put in nebulization cup + 2 ml lidocaine 2%), nebulized prior to the induction of anesthesia.
干预措施: Epinephrine Inhalation Solution (Drug)
Group( OL) Oxymetazoline and lidocaine group
Group OL (63 patients): These patients received five drops of lidocaine hydrochloride (Xylocaine 2%, 20 mg/ml; AstraZeneca, London, UK) using a prefilled dropper, followed by six drops of hydrochloride Oxymetazoline (Otrivin adult nasal drops 0.1%, 10 ml of 1 mg/ml; Novartis Consumer Health, UK Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, UK) in each nostril in the pre-induction room just before the induction of anesthesia
干预措施: Epinephrine Inhalation Solution (Drug)
结局指标
主要结局
estimate the degree of epistaxis
时间窗: the whole intraoperative time
Epistaxis degrees during intubation is classified to 4 degrees 1-No bleeding means No interference with the laryngoscopic view,2- minimal bleeding means Just blood-tinged ETT but no blood on the vocal cords or mouth floor, 3-moderate bleading means Blood on the vocal cords and mouth floor which Interferes with the laryngoscopic view, but is easy to confirm the laryngeal structure,4-severe bleeding means Blood on the vocal cords and mouth floor Hard to visualize the laryngeal structure without suction because of bleeding Nasal bleeding after intubation will be assessed by utilizing pharyngeal aspiration with a 14-F, 50-cm-long suction catheter linked to a 2.5-m-long suction tube at -100 mmHg pressure \[13\]. Based on the amount of blood sucked via the suction tube into the container, the severity of epistaxis was determined: none = no bleeding; mild = blood volume \< 50 cm; moderate = 50 cm \< blood volume \< 300 cm; severe = blood volume \> 300 cm
次要结局
- intraoperative analgesia(the whole intraoperative period)
- intraoperative blood loss from surgical field(the whole intraoperative period)