I-gel vs LMA Supreme in Laparoscopic Gynecological Surgery

Not Applicable

Completed

Conditions: Anaesthesia
Airway Morbidity

Interventions: Device: i-gel Evaluation
Device: Laryngeal mask Supreme Evaluation

Registration Number: NCT02923427

Lead Sponsor: Dokuz Eylul University

Brief 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).

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 112

Inclusion Criteria

American Society of Anesthesiologists classification group I-II
between 18-65 years
undergoing elective laparoscopic gynecological surgery

Exclusion Criteria

Those with any neck or upper respiratory tract pathology
Those at risk of gastric content regurgitation/aspiration (previous upper Gastrointestinal system surgery, known hiatus hernia, gastroesophageal reflux, history of peptic ulcers, full stomach, pregnancy)
Those with low pulmonary compliance or high airway resistance (chronic pulmonary diseases)
Obese patients (BMI >35)
Those with throat pain, dysphagia and dysphonia
Those with possible or previous difficult airway
Those with operations planned for longer than 4 hours
Conversion to laparatomy
Neuromuscular blocking agent used

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
i-gel	i-gel Evaluation	Insertion of the "i-gel" and evaluation of its clinical performance
Laryngeal mask Supreme	Laryngeal mask Supreme Evaluation	Insertion of the "Laryngeal mask Supreme" and evaluation of its clinical performance

Primary Outcome Measures

Name	Time	Method
Airway Seal Pressure Values	At baseline and at 15, 30 and 60 minutes	This value is important as it indicates the feasibility of positive pressure ventilation and the degree of airway protection from supracuff soiling. It is also used in LMA studies as an index of successful placement.Airway pressures of ≈20 cm H2O are typically required in routine practice.

Secondary Outcome Measures

Name	Time	Method
Mean Airway Pressure Values	At baseline and at 15, 30 and 60 minutes	Mean airway pressure typically refers to the mean pressure applied during positive-pressure mechanical ventilation. Mean airway pressure correlates with alveolar ventilation, arterial oxygenation, hemodynamic performance, and barotrauma.
Sufficiency of Pneumoperitoneum	baseline	Number of Participants with Sufficiency of Pneumoperitoneum. Sufficiency of pneumoperitoneum for the surgical procedure according to surgeon, described as sufficient or insufficient questionaire.
Disphagia	postoperative first hour and 24th hour	We asked the question that you have a pain while you were swallowing, yes or not.
Visual Quality	during pneumoperitoneum	quality of surgical view will evaluate by the scala. quality of surgical view will be assessed with points from 1 to 4 by the surgeon blind to the airway device; (1:best, 4: worst).
Gastric Tube Insertion	following airway device insertion up to 5 minutes	Number of Participants According to Ease of Gastric Tube Insertion.Ease of passage of a gastric tube as: very easy, easy, difficult or very difficult.
Postoperative Pharyngolaryngeal Morbidity	postoperative first hour and 24th hour	Sore throat evaluted by Visual Analogue Scale. The visual analog scale, also known as the graphic rating scale is a simple, valid and reliable subjective measure. Scores are ranked on a 10-cm line that stretches between two extremes - "no pain" and "worst pain". Total range provided"0 (no pain) to 10 (worst pain).
Dysphonia With Yes/no.	postoperative first hour and 24th hour	We evaluated while a patient was talking with us that the patient has dysphonia or not .