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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 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.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.
Sponsor: Adiyaman University Research Hospital

Current Primary Outcome:

  • Insertion time [ Time Frame: Perioperative ]
    It was assessed that how many secs it takes to insert the device
  • Attempts to insertion [ Time Frame: Perioperative ]
    It was assessed that how many attempts needed to insert the device
  • Airway related complications [ Time Frame: Perioperative ]
    Airway related complications like bronchospasm,gastric regurgitation,smooth tissue damages were assessed


Original Primary Outcome: Peak airway pressure cmH2O [ Time Frame: Perioperative ]

Current Secondary Outcome:

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


Original Secondary Outcome:

  • Heart Rate bpm [ Time Frame: Perioperative ]
  • Systolic blood pressure mmHg [ Time Frame: Perioperative ]
  • Diastolic blood pressure mmHg [ Time Frame: Perioperative ]


Information By: Adiyaman University Research Hospital

Dates:
Date Received: September 5, 2016
Date Started: January 2015
Date Completion:
Last Updated: May 6, 2017
Last Verified: May 2017