I-gel vs LMA Supreme in Laparoscopic Gynecological Surgery

Dokuz Eylul University112 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

112

Conditions

Airway Morbidity Anaesthesia

Interventions

Laryngeal mask Supreme EvaluationDEVICE

Evaluation of clinical performance in terms of Insertion, ventilation and complications

i-gel EvaluationDEVICE

Evaluation of clinical performance in terms of Insertion,ventilation and complications

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. American Society of Anesthesiologists classification group I-II 2. between 18-65 years 3. undergoing elective laparoscopic gynecological surgery Exclusion Criteria: 1. Those with any neck or upper respiratory tract pathology 2. 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) 3. Those with low pulmonary compliance or high airway resistance (chronic pulmonary diseases) 4. Obese patients (BMI \>35) 5. Those with throat pain, dysphagia and dysphonia 6. Those with possible or previous difficult airway 7. Those with operations planned for longer than 4 hours 8. Conversion to laparatomy 9. Neuromuscular blocking agent used

Locations (1)

Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation

Izmir, Turkey (Türkiye)

Outcomes

Primary Outcomes

Airway Seal Pressure Values

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.

Time frame: At baseline and at 15, 30 and 60 minutes

Secondary Outcomes

Visual Quality

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).

Time frame: during pneumoperitoneum

Gastric Tube Insertion

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.

Time frame: following airway device insertion up to 5 minutes

Postoperative Pharyngolaryngeal Morbidity

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).

Time frame: postoperative first hour and 24th hour

Sufficiency of Pneumoperitoneum

Number of Participants with Sufficiency of Pneumoperitoneum. Sufficiency of pneumoperitoneum for the surgical procedure according to surgeon, described as sufficient or insufficient questionaire.

Time frame: baseline

Mean Airway Pressure Values

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.

Data from ClinicalTrials.gov

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