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Completed

NCT Number: NCT02925598

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

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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Key information

Conditions

Respiratory Aspiration of Gastric Content

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

I-gel LMA insertion

Device

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

AuraGain LMA insertion

Device

'AuraGain LMA insertion' was done following anesthesia induction.

ETT insertion

Device

'ETT insertion' was done following anesthesia induction.

Primary outcomes

  1. Insertion time

    Time frame: Perioperative

    It was assessed that how many secs it takes to insert the device

  2. Attempts to insertion

    Time frame: Perioperative

    It was assessed that how many attempts needed to insert the device

  3. Airway related complications

    Time frame: Perioperative

    Airway related complications like bronchospasm,gastric regurgitation,smooth tissue damages were assessed

Secondary outcomes

  1. Heart Rate bpm

    Time frame: Perioperative

    Heart rates changes were evaluated preoperative and after device insertion and then in every 5 mins.

  2. Systolic blood pressure mmHg

    Time frame: Perioperative

    Systolic blood pressure changes were evaluate preoperative,following device insertion then in every 5 mins.

  3. Diastolic blood pressure mmHg

    Time frame: Perioperative

    Diastolic blood pressures were evaluated preoperative,following device insertion then in every 5 mins.

  4. Peak airway pressure

    Time frame: Perioperative

    During the surgery peak airway pressures were assessed following device insertion snd then in every 5 mins.

Sponsors and collaborators

Lead sponsor

Adiyaman University Research Hospital

Other

Registry information

Official study title

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

Acronym: AILMALC

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 6, 2016
Registry last updated
May 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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