Laryngeal Mask Supreme & I-Gel in Edentulate Geriatric Patients

Status Recruiting

Clinical Trial Summary

The primary aim of this study is to evaluate ease and duration of placing Laryngeal Mask Supreme (LM) and applying I-gel in geriatric patients without teeth. The secondary aim is to compare their effects on ventilation parameters.

Clinical Trial 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: laryngeal mask airway - Supreme Procedure: The investigation protocol contains the following sections: 1. Induction of anaesthesia: Preoxygenation will be provided at 6 Liter/min oxygen for three minutes by using a facial mask. After anesthesia induction with fentanyl 1-2 μg/kg and propofol 1-2 mg/kg (12), mask ventilation will be applied with 100% oxygen. 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. Maintenance of anesthesia will be achieved with sevoflurane 1,5-2,5% in a mixture of 50% O2/ 50% nitrogen protoxide. Sevoflurane concentrations will be adjusted to keep bispectral index values at 40-60. 5. Measurement of airway seal pressure (oropharyngeal leak pressure (OLP): at baseline, and two minutes after the airway tool is placed, every 15 minutes until the operation ends and before the airway tool is removed. 6. Ventilatory mechanics and parameters and hemodynamic parameters are measured at baseline, and two minutes after the airway tool is placed, every 15 minutes until the operation ends and before the airway tool is removed. 7. Perioperative complications: Cough, vomiting, laryngeal spasm, laryngeal Stridor 8. 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 (visual analogue scale :10-point scale), dysphonia (yes/no), dysphagia (yes/no). ;

Study Design

Related Conditions & MeSH terms

Airway Morbidity

Clinical Trial Details

NCT number	NCT03760679
Study type	Interventional
Source	Dokuz Eylul University
Contact	Sule Özbilgin
Phone	05055252901
Email	ozbilginsule@gmail.com
Status	Recruiting
Phase	N/A
Start date	August 1, 2018
Completion date	December 1, 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04109898` - Comparison of Ease of I-gel Insertion With Two Different Techniques in Adults	N/A
Recruiting	`NCT05030337` - Optimising Ventilation in Preterms With Closed-loop Oxygen Control	N/A
Completed	`NCT02820792` - Non-Crossover Study of the LMA Protector Versus Ambu AuraGain	N/A
Not yet recruiting	`NCT02458794` - Crossover Study of the LMA SupremeTM vs Ambu-Aura GainTM	N/A
Completed	`NCT02572232` - Supraglottic Airway Devices in Pediatric Difficult Airway Situations	N/A
Completed	`NCT04158323` - What is the Gold Standard of Airway Management in the Anticipated Difficult Airway
Completed	`NCT04158271` - Evaluation of Techniques for Tracheal Tube Exchange in Standard and Critical Care Patients	N/A
Active, not recruiting	`NCT02627755` - GlideScope® vs GlideScope® + aScope® for Managing Difficult Airways.	N/A
Completed	`NCT02923427` - I-gel vs LMA Supreme in Laparoscopic Gynecological Surgery	N/A
Completed	`NCT02300337` - Comparison of Reduced Cuff-pressure of the Laryngeal Tube Under General Anesthesia	N/A
Completed	`NCT01749033` - A New Insertion Technique for Laryngeal Mask Airway	N/A
Completed	`NCT02611986` - Evaluation of Video Laryngoscopy (Video Macintosh-blade) and Direct Laryngoscopy (EMMA-Study)	N/A
Enrolling by invitation	`NCT03760692` - I-gel vs Ambu AuraGain in Laparoscopic Gynecological Surgery	N/A
Completed	`NCT01367678` - Mucosal Pressure of the Laryngeal Mask Airway Supreme Versus the i-Gel in Paralyzed Anesthetized Female Patients	N/A
Recruiting	`NCT03251053` - Adverse Airway Effects From Tobacco and E-Cigarettes	N/A
Recruiting	`NCT02777840` - High Flow Oxygen With THRIVE Gives Better Oxygenation in Rapid Sequence Induction Patients	N/A
Completed	`NCT02048657` - The Effectiveness of Foley Airway Stylet Tool on Proseal LMA Insertion	N/A
Completed	`NCT01371773` - Repositioning Method for Left-sided Double Lumen Tubes	N/A
Terminated	`NCT02495259` - Comparison of Double Lumen Tube Placement Techniques	N/A
Recruiting	`NCT02104453` - Comparative Evaluation of Three Airway Maneuvers in the Unconscious Apneic Person	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Laryngeal Mask Supreme and I-Gel in Edentulate Geriatric Patients

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms