Comparison of I-gel and LMA Supreme Without Neuromuscular Blocker in Laparoscopic Gynecological Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Airway Morbidity
- Sponsor
- Dokuz Eylul University
- Enrollment
- 112
- Locations
- 1
- Primary Endpoint
- Airway Seal Pressure Values
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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).
Investigators
Sule Ozbilgin
Dokuz Eylul University, MD, Anesthesiologists.
Dokuz Eylul University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Airway Seal Pressure Values
Time Frame: 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 Outcomes
- Mean Airway Pressure Values(At baseline and at 15, 30 and 60 minutes)
- Sufficiency of Pneumoperitoneum(baseline)
- Disphagia(postoperative first hour and 24th hour)
- Visual Quality(during pneumoperitoneum)
- Gastric Tube Insertion(following airway device insertion up to 5 minutes)
- Postoperative Pharyngolaryngeal Morbidity(postoperative first hour and 24th hour)
- Dysphonia With Yes/no.(postoperative first hour and 24th hour)