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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-04-30

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.

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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.

Conditions

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Respiratory Aspiration of Gastric Content

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Caregivers

Study Groups

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I-gel LMA

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.

Group Type EXPERIMENTAL

I-gel LMA insertion

Intervention Type DEVICE

'I-gel LMA insertion' was done following anesthesia induction.

AuraGain LMA

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.

Group Type EXPERIMENTAL

AuraGain LMA insertion

Intervention Type DEVICE

'AuraGain LMA insertion' was done following anesthesia induction.

Endotracheal tube (ETT)

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.

Group Type EXPERIMENTAL

ETT insertion

Intervention Type DEVICE

'ETT insertion' was done following anesthesia induction.

Interventions

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I-gel LMA insertion

'I-gel LMA insertion' was done following anesthesia induction.

Intervention Type DEVICE

AuraGain LMA insertion

'AuraGain LMA insertion' was done following anesthesia induction.

Intervention Type DEVICE

ETT insertion

'ETT insertion' was done following anesthesia induction.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No