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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02925598
Acronym
AILMALC
Enrollment
114
Registered
2016-10-06
Start date
2015-01-31
Completion date
2015-04-30
Last updated
2017-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Aspiration of Gastric Content

Keywords

Laringeal masks, Cholecystectomy, Laparascopic, Intubation, intratracheal

Brief summary

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

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.

Interventions

DEVICEI-gel LMA insertion

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

DEVICEAuraGain LMA insertion

'AuraGain LMA insertion' was done following anesthesia induction.

DEVICEETT insertion

'ETT insertion' was done following anesthesia induction.

Sponsors

Adiyaman University Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Insertion timePerioperativeIt was assessed that how many secs it takes to insert the device
Attempts to insertionPerioperativeIt was assessed that how many attempts needed to insert the device
Airway related complicationsPerioperativeAirway related complications like bronchospasm,gastric regurgitation,smooth tissue damages were assessed

Secondary

MeasureTime frameDescription
Heart Rate bpmPerioperativeHeart rates changes were evaluated preoperative and after device insertion and then in every 5 mins.
Peak airway pressurePerioperativeDuring the surgery peak airway pressures were assessed following device insertion snd then in every 5 mins.
Systolic blood pressure mmHgPerioperativeSystolic blood pressure changes were evaluate preoperative,following device insertion then in every 5 mins.
Diastolic blood pressure mmHgPerioperativeDiastolic blood pressures were evaluated preoperative,following device insertion then in every 5 mins.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026