Postoperative Sore Throat in Children: Comparison Between Two Supraglottic Devices, Ambu® AuraOnce™ Laryngeal Mask Airway (LMA) and I-Gel® in Children Undergoing Elective Lower Abdominal or Orthopedic Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Frequency and severity of postoperative sore throat
研究概览
简要总结
Sore throat is minor but well recognized complaint after receiving general anaesthesia. It is rated as 8th most undesirable outcome in postoperative period.It not only affects the patient's satisfaction but also can affect patient activities after leaving hospital.
Many factors can contribute to postoperative sore throat and the incidence has been found to vary with the method by which airway is managed.
The study is conducted to compare the severity and frequency of postoperative sore throat in children undergoing elective surgery following the use of AmbuAuraOnce LMA and I-Gel. The study will be done in children who are able to self-report the severity of sore throat.
This study will help us to determine which supraglottic device (I-gel vs. AmbuAuraOnce LMA) is better in terms of causing less complication spells of sore throat. The use of such device will not only reduce the severity and frequency of postoperative sore throat that may affect the activities of patient after leaving hospital but also will improve satisfaction level of patient and parents.
详细描述
OBJECTIVE
The objective of our study is to assess the frequency and severity of postoperative sore throat by comparison between two supraglottic devices, AuraOnce Laryngeal Mask Airway (LMA) and I-gel in children undergoing elective lower abdominal or orthopedic surgery.
HYPOTHESIS
Use of I-gel in children undergoing elective lower abdominal or orthopedic surgery is associated with decrease frequency and severity of postoperative sore throat as compared to use of AuraOnce Laryngeal Mask Airway.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •6 to 16 year old patients of both gender
- •ASA (American Society of Anesthesiologists) I and ASA II patients
- •Scheduled for elective lower abdominal surgery (inguinal hernia repair or circumcision) or orthopedic surgery (upper and lower limb) under General anesthesia.
排除标准
- •Patients with risk of aspiration (incomplete NPO (Nil per oral), Gastroesophageal reflux disease, Congenital anatomic abnormalities of aero digestive tract, delayed gastric emptying, altered mental status)
- •Difficult airway(difficult mask ventilation or difficult laryngoscopy, Cormack-Lehane grade more than 2 in patient history, trismus, limited mouth opening, trauma or mass)
- •Children who are unable to self-report pain using a four-point categorical pain scale
- •Refusal of the parent
- •Refusal of the child to give assent
- •Patients having pre-existing sore throat or symptoms of Upper respiratory tract infection.
- •Obese children i.e. BMI for age percentile equal to or greater than the 95th percentile on BMI-for-age percentile growth charts.
研究组 & 干预措施
I-Gel group
I-gel will be used for maintenance of airway during general anaesthesia
干预措施: I-Gel (Device)
LMA ambu auraonce group
LMA ambu auraonce will be used for maintenance of airway during general anaesthesia
干预措施: LMA (Device)
结局指标
主要结局
Frequency and severity of postoperative sore throat
时间窗: 24 hours
To assess the frequency and severity of postoperative sore throat by comparison between two supraglottic devices, AuraOnce Laryngeal Mask Airway (LMA) and I-gel in children undergoing elective lower abdominal or orthopedic surgery. * Postoperative Sore Throat: Constant pain or discomfort in the throat which is independent of swallowing postoperatively for 24 hours. * Severity of Sore throat: The severity of sore throat will be measured by a four-point categorical pain scale. Grading of severity is as follow: 0 = no sore throat 1. mild (complains of sore throat only on asking) 2. moderate (complains of sore throat on his/her own) 3. severe (change of voice or hoarseness, associated with throat pain). Chi-square test will be applied to compare frequency and severity of post-operative sore throat between two groups. P ≤ 0.05 will be considered as significant.
次要结局
- Insertion time(5 minutes)
- Immediate complications(Immediately after removal of supraglottic device)
- Total number of attempts(5 minutes)
- Ease of insertion(5 minutes)
- Oropharyngeal seal pressure(5 minutes)
研究者
Dr. Malika Hameed
Resident Anaesthesiology
Aga Khan University