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

NCT02925598 | Completed DMC

• 1 other identifier: 2015/178
• Study Type: interventional
• Target: 114
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Respiratory Aspiration of Gastric Content

Keywords

Laringeal masks; Cholecystectomy, Laparascopic; Intubation, intratracheal

Outcome Measures

Primary Outcomes (3)

• Insertion time

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

  Perioperative

• Attempts to insertion

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

  Perioperative

• Airway related complications

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

  Perioperative

Secondary Outcomes (4)

• Heart Rate bpm

  Perioperative

• Systolic blood pressure mmHg

  Perioperative

• Diastolic blood pressure mmHg

  Perioperative

• Peak airway pressure

  Perioperative

Study Arms (3)

I-gel LMA

EXPERIMENTAL

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.

Device: I-gel LMA insertion

AuraGain LMA

EXPERIMENTAL

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.

Device: AuraGain LMA insertion

Endotracheal tube (ETT)

EXPERIMENTAL

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.

Device: ETT insertion

Interventions

I-gel LMA insertion DEVICE

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

I-gel LMA

AuraGain LMA insertion DEVICE

'AuraGain LMA insertion' was done following anesthesia induction.

AuraGain LMA

ETT insertion DEVICE

'ETT insertion' was done following anesthesia induction.

Endotracheal tube (ETT)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (ASA) 1-2 physical status scheduled for elective LC

You may not qualify if:

• 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

Sponsors & Collaborators

• Adiyaman University Research Hospital: lead

Study Officials

• Ulku Sabuncu, MD

  Adiyaman university Research and Educational Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Ulku Sabuncu, MD, Anesthesiology and Reanimation

Study Record Dates

• First Submitted: September 5, 2016
• First Posted: October 6, 2016
• Study Start: January 1, 2015
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: May 9, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share