AuraGainTM and I-Gel® Laryngeal Masks in General Anesthesia for Laparoscopic Cholecystectomy
- Conditions
- Respiratory Aspiration of Gastric Content
- Interventions
- Device: I-gel LMA insertionDevice: AuraGain LMA insertionDevice: ETT insertion
- Registration Number
- NCT02925598
- Lead Sponsor
- Adiyaman University Research Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 114
- (ASA) 1-2 physical status scheduled for elective LC
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description I-gel LMA I-gel LMA insertion 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. AuraGain LMA AuraGain LMA insertion 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. Endotracheal tube (ETT) ETT insertion 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.
- Primary Outcome Measures
Name Time Method Airway related complications Perioperative Airway related complications like bronchospasm,gastric regurgitation,smooth tissue damages were assessed
Insertion time Perioperative It was assessed that how many secs it takes to insert the device
Attempts to insertion Perioperative It was assessed that how many attempts needed to insert the device
- Secondary Outcome Measures
Name Time Method Heart Rate bpm Perioperative Heart rates changes were evaluated preoperative and after device insertion and then in every 5 mins.
Systolic blood pressure mmHg Perioperative Systolic blood pressure changes were evaluate preoperative,following device insertion then in every 5 mins.
Peak airway pressure Perioperative During the surgery peak airway pressures were assessed following device insertion snd then in every 5 mins.
Diastolic blood pressure mmHg Perioperative Diastolic blood pressures were evaluated preoperative,following device insertion then in every 5 mins.