The Use of Nasopharyngeal Airway as an Alternative to Laryngeal Mask Airway to Maintain Anaesthesia in Patients Undergoing Four-Lids Blepharoplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 148
- 试验地点
- 2
- 主要终点
- Incidence of postoperative soar throat
研究概览
简要总结
General anaesthesia demands securing patient's airway either with endotracheal tube or laryngeal mask (LMA); however, both carry the disadvantage of postoperative soar throat. Nasopharyngeal airway (NPA) can be an alternative without the risk of postoperative soar throat.6 The primary end point of our study is to assess the incidence of soar throat with the use of NPA compared to LMA in patients receiving general anaesthesia during blepharoplasty.
详细描述
After approval of medical ethical committee at Ain-Shams University and obtaining written informed consent, 148 adult ASA II-III patients aged between 40 and 60 years old admitted to Ain-Shams university hospitals for blepharoplasty will be enrolled in this study.
Patients will then be randomly and evenly divided into two equal groups (74 patients each) using computer-generated list:
Group N: Patients' nasal mucosa will be anaesthetized and vasoconstricted. K-Y gel will be applied to the tip of nasopharyngeal airway (NPA) of appropriate size. The NPA will then be advanced into the dominant nostril along the septum horizontally.
Group L: K-Y gel will be applied to the tip of the laryngeal mask (LMA) of appropriate size. The LMA will be introduced along the hard palate towards the hypopharynx until resistance is felt.
Anaesthesia will be maintained by sevoflurane 3-4% and propofol infusion 0.5-1 mg.kg-1.hr-1.All patients will receive local infiltration anaesthesia given by the surgeon.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •consented patients, age: 40-60 years old, ASA II-III
排除标准
- •Uncontrolled hypertension (systolic blood pressure > 160 mmHg) or ischaemic heart disease.
- •Pre-existing coagulation defects or anticoagulation medication.
- •Renal impairment.
- •Recent upper respiratory tract infections, asthma, chronic obstructive pulmonary disease, and smoking.
- •History of obstructive sleep apnea.
- •Chronic drug or alcohol abuse.
- •Morbid obesity; BMI >40 or BMI >35 and experiencing obesity-related health conditions, such as high blood pressure or diabetes.
- •Allergy to any of the drugs used in the study.
研究组 & 干预措施
Group N
Patients' nasal mucosa will be anaesthetized and vasoconstricted. K-Y gel will be applied to the tip of nasopharyngeal airway (NPA) of appropriate size. The NPA will then be advanced into the dominant nostril along the septum horizontally.
干预措施: Nasopharyngeal airway or laryngeal mask airway (Device)
Group L
K-Y gel will be applied to the tip of the laryngeal mask (LMA) of appropriate size. The LMA will be introduced along the hard palate towards the hypopharynx until resistance is felt.
干预措施: Nasopharyngeal airway or laryngeal mask airway (Device)
结局指标
主要结局
Incidence of postoperative soar throat
时间窗: 2-4 hours postoperative
presence or abscence of soar throat
次要结局
未报告次要终点
研究者
Hala Salah El-Din El-Ozairy
Lecturer of Anaesthesia, ICU and Pain management, Faculty of Medicine, Ain Shams University
Ain Shams University