The aim of the study is to compare the performance of two supraglottic airway devices (SGA), the new Ambu AuraGain and the LMA Supreme, in sixty female patients undergoing gynaecologic laparoscopy in the trendelemburg position. Primary outcome is the airway seal pressure. Secondary outcomes are ease of insertion, quality of ventilation, endoscopic view of the glottis, gastric tube passage and complications.
The patients are randomly assigned to 2 groups: * Group 1: Ambu AuraGain. * Group 2: LMA Supreme, Teleflex Procedure: The investigation protocol contains the following sections: 1. Induction of anaesthesia. Intravenous infusion of remifentanil and propofol targeting the effect site (2-4 ng/ml and 4-6 µg/ml respectively). No muscle relaxant will be used for insertion of the SGA. Rocuronium 0.2 mg/Kg will be administered before initiation of pneumoperitoneum. 2. Insertion of the SGAs. The size of the SGA device used is based on the manufacturers' recommendations. All devices are deflated a lubricated prior to use. Once inserted, the cuff is be inflated with a manometer up to 60 cm H20 Position of the device is adjusted if needed. Data recorded: size of SGA, time an number of attempts. 3. Fibreoptic evaluation of the SGAs anatomical position: complete view of the vocal cords (I), epiglottis visible inside, but not causing obstruction (II), epiglottis visible and obstructing the glottic inlet (III), or glottic structures not identified (IV). 4. Functionality of the gastric drainage channel of the SGAs: passage of a 16 G size tube. 5. Measurement of airway seal pressure (oropharyngeal leak pressure (OLP): at baseline, and at 15, 30 and 60 minutes. The maximum pressure allowed is 40 cm H2O. 6. Ventilatory mechanics and parameters are measured at baseline, and at 15, 30 and 60 minutes. Perioperative complications: Hiccup, gastric distension, regurgitation / Aspiration, airway obstruction, laryngospasm, dental, mucosal or tongue injury, hypoxia (SpO2 \< 92%) 7. Removal of the SGAs: Presence of blood - 3 level grading (+/++/+++) Postoperative complications: sore throat, hoarseness, dysphonia, dysphagia, dysphagia: 3-point scale
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Evaluation of clinical performance in terms of Insertion, ventilation, position and complications
Evaluation of clinical performance in terms of Insertion, ventilation, position and complications
Gynecologic laparoscopic surgery in the trendelemburg position
Ambulatory Surgery, Hospital Clinic de Barcelona
Barcelona, Barcelona, Spain
Airway seal pressure
Maximum airway pressure that the device can achieve without oropharyngeal leak of gas.
Time frame: At 15 minutes
Ease of insertion of the device
Time needed to insert the device
Time frame: Baseline
Change in Quality of ventilation
number of manoeuvres/corrections required
Time frame: At baseline and at 15, 30 and 60 minutes
Endoscopic view of glottic structures
Assessment of alignment with the glottic inlet as: complete view of the vocal cords (I), epiglottis visible inside, but not causing any obstruction (II), epiglottis visible and causing obstruction (III) or glottis not identified (IV)
Time frame: At 15 minutes
Gastric tube insertion
Ease of passage of a gastric tube as: easy, difficult or impossible
Time frame: At 5 minutes
Incidence of perioperative complications
number of patients with adverse events: Airway obstruction, desaturation, Aspiration, oropharyngeal trauma, sore throat
Time frame: 2 hours
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