AuraGainTM and I-Gel® Laryngeal Masks in General Anesthesia for Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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The standard procedure used for airway control in general anesthesia for LC (laparoscopic cholecystectomy) is endotracheal intubation (EI). AuraGain and I-Gel are supraglottic airway devices (SADs) used for airway control for certain types of surgeries. The aim of this study was to evaluate and compare the performances of new types of SADs with EI regarding their insertion times, durations, perioperative complications and effects on hemodynamic parameters and peak airway pressures (Paw) in LC as well.

Detailed Description
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The standard procedure used for airway control in general anesthesia for LC (laparoscopic cholecystectomy) is endotracheal intubation (EI). AuraGain and I-Gel are supraglottic airway devices (SADs) used for airway control for certain types of surgeries.Previous studies have investigated and/or compared the performance of ProSeal™ LMA (Intavent Orthofix, Maidenhead, UK) during LC. But the performances of I-Gel and AuraGain have not been studied well yet. The main aim of this study was to evaluate and compare the performances of new types of SADs (i.e. AuraGain and I-Gel) with endotracheal intubation regarding their insertion times, ease of insertion and perioperative complications. The secondary aim was to observe their effects on hemodynamic parameters and peak airway pressures.

Official Title
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AuraGainTM and I-Gel® Laryngeal Masks in General Anesthesia for Laparoscopic Cholecystectomy - Performance Characteristics and Effects on Hemodynamics

Conditions
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Respiratory Aspiration of Gastric Content

Intervention / Treatment
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* Device: I-gel LMA insertion
* Device: AuraGain LMA insertion
* Device: ETT insertion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (ASA) 1-2 physical status scheduled for elective LC Exclusion Criteria: under the age of 18, history of hiatus hernia, gastroesophageal reflux, body mass index (BMI) > 30 kg m-2, ASA physical status 3 or over and patients who met the difficult intubation criteria

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I-gel LMA<br>I-gel LMA insertion: I-gel insertion was done in supine position and with a standard gel pillow with the patient's head on following anesthesia induction. The insertion was verified with the manual ventilation of the patient and EtCO2 waveform. | Device: I-gel LMA insertion<br>* 'I-gel LMA insertion' was done following anesthesia induction.<br>|
| Experimental: AuraGain LMA<br>AuraGain insertion:AuraGain LMA insertion was done in supine position and with a standard gel pillow with the patient's head on following anesthesia induction. The insertion was verified with the manual ventilation of the patient and EtCO2 waveform. | Device: AuraGain LMA insertion<br>* 'AuraGain LMA insertion' was done following anesthesia induction.<br>|
| Experimental: Endotracheal tube (ETT)<br>Endotracheal tube insertion: Endotracheal tube (ETT) insertion was done in supine position and with a standard gel pillow with the patient's head on following anesthesia induction. The insertion was verified with the manual ventilation of the patient and EtCO2 waveform. | Device: ETT insertion<br>* 'ETT insertion' was done following anesthesia induction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insertion time | It was assessed that how many secs it takes to insert the device | Perioperative | 
| Attempts to insertion | It was assessed that how many attempts needed to insert the device | Perioperative | 
| Airway related complications | Airway related complications like bronchospasm,gastric regurgitation,smooth tissue damages were assessed | Perioperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate bpm | Heart rates changes were evaluated preoperative and after device insertion and then in every 5 mins. | Perioperative | 
| Systolic blood pressure mmHg | Systolic blood pressure changes were evaluate preoperative,following device insertion then in every 5 mins. | Perioperative | 
| Diastolic blood pressure mmHg | Diastolic blood pressures were evaluated preoperative,following device insertion then in every 5 mins. | Perioperative | 
| Peak airway pressure | During the surgery peak airway pressures were assessed following device insertion snd then in every 5 mins. | Perioperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laringeal masks, Cholecystectomy, Laparascopic, Intubation, intratracheal