I-gel vs LMA Supreme in Laparoscopic Gynecological Surgery
Condition: Airway Morbidity; Anaesthesia
Study type: Interventional

Summary: 
      To compare the effects of i-gel and Laryngeal mask airway Supreme (LMA-Supreme) on
      ventilation parameters and surgical view during Trendelenburg Position laparoscopic
      gynecological surgery in cases administered positive pressure ventilation without the use of
      neuromuscular agents.
    

Detailed description: 
      Prospective, randomized and double-blind study, aged from 18 to 65 years undergoing elective
      laparoscopic gynecological surgery.

      The patients are randomly assigned to 2 groups:

        -  Group 1: i-gel

        -  Group 2: LMA- Supreme

      Procedure:

      The investigation protocol contains the following sections:

        1. Induction of anaesthesia. For preoperative sedation 0.02 mg/kg midazolam IV will be
           administered. 2 minutes of 0.2 µ/kg/min remifentanil and 6 mg kg st-1 propofol infusion,
           IV 1-2 mg kg-1 propofol . No muscle relaxant will be used for insertion of the airway
           device.

        2. Bispectral index values will be held between 40-60.Bispectral index values will be
           within this interval by increasing or decreasing propofol infusion by 1 mg/kg after
           additional bolus dose of propofol (1 mg/kg).

        3. Insertion of the airway device. The size of the airway 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 Data recorded: size
           of airway device, time an number of attempts.

        4. Anesthesia maintenance will be ensured by 50% O2/air with 0.1-0.4 µ kg/min-1
           remifentanil and 50-150 µ kg/ min-1 (4-10 mg/kg/hr) propofol IV infusion

        5. Functionality of the gastric drainage channel of the airway device: passage of a 14 G
           size tube.

        6. Measurement of airway seal pressure (oropharyngeal leak pressure (OLP): at baseline, and
           at 2 minutes after airway device insertion (T1), 10 minutes after insufflation (T2),
           before desufflation (T3), before removal of airway device (T4). The maximum pressure
           allowed is 40 cm H2O.

        7. Ventilatory mechanics and parameters and hemodynamic parameters are measured at
           baseline, and at T1, T2, T3 and T4.

        8. Perioperative complications: Cough, vomiting, laryngeal spasm, laryngeal Stridor, airway
           intervention requirements, hypoxia (SpO2 < 92%)

        9. Removal of the airway device: Presence of blood - 3 level grading (1:no blood; 2: trace
           amounts of blood; 3: clear amounts of blood). Complications: sore throat ( VAS:10-point
           scale), dysphonia (yes/no), dysphagia (yes/no).
    

Intervention name(s): Laryngeal mask Supreme Evaluation; i-gel Evaluation
Intervention type(s): Device; Device
Intervention description(s): Evaluation of clinical performance in terms of Insertion, ventilation and complications; Evaluation of clinical performance in terms of Insertion,ventilation and complications
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: laryngeal mask Supreme; i-gel; laparoscopic gynecological surgery