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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
70
I-gel is the single use supraglottic airway from intersurgical, UK (Intersurgical Ltd, Wokingham, Berkshire, UK) with an anatomically designed mask made of a gel like thermoplastic elastomer to fit over perilaryngeal and hypopharyngeal structures. It is designed to separate the gastrointestinal and respiratory tracts and also allow a gastric tube to be passed into the stomach.
The AmbuAuraOnce (Ambu A/S, Ballerup, Denmark) is a supraglottic airway device with an inflatable cuff. It is a disposable device as well, but unlike I-gel, it does not feature a gastric channel.
Aga Khan University
Karachi, Sindh, Pakistan
Frequency and severity of postoperative sore throat
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.
Time frame: 24 hours
Immediate complications
Frequency will be calculated for immediate complications which includes laryngospasm, stridor, coughing, aspiration etc.
Time frame: Immediately after removal of supraglottic device
Insertion time
time of insertion of supraglottic device
Time frame: 5 minutes
Ease of insertion
Ease of insertion
Time frame: 5 minutes
Total number of attempts
maximum three attempts
Time frame: 5 minutes
Oropharyngeal seal pressure
seal pressure
Time frame: 5 minutes
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