Background: Supraglottic airway devices have increasingly been used as the airway technique of choice in laparoscopic surgeries. This study compared the efficacy and safety of the Baska Mask with endotracheal tube (ETT) in patients undergoing elective laparoscopic cholecystectomy.Research design and methods: This single-center, prospective, randomized controlled trial recruited 60 patients aged 18-75 years with American Society of Anesthesiologists' classifications I to III. The time taken to achieve effective airway, number of attempts, ease of insertion, ventilation parameters, hemodynamics data, and pharyngolaryngeal complications were recorded. Results: The time taken to achieve effective airway was shorter for the Baska group (26.6 ± 4.7 vs. 47.2 ± 11.8 s; p < 0.001), although the first-time insertion success rate was ≥90% for both groups. The ETT group experienced more pharyngolaryngeal complications, including cough, trauma, spasm, dysphonia, and sore throat, during device insertion and removal and had higher systolic and diastolic blood pressures during intubation (p = 0.001). The Baska Mask achieved significantly lower peak airway pressure (p = 0.024) with stable oropharyngeal leak pressure ≥33 cmH2O throughout the surgery.Conclusions: The Baska Mask is a suitable alternative to endotracheal intubation in selected patients undergoing laparoscopic cholecystectomy, with shorter insertion times, fewer perioperative complications, and improved ventilatory performance and hemodynamic response.Trial registration: The trial is registered at ClinicalTrials.gov (NCT03045835), 8 February 2017.
RCT Entities:
Background: Supraglottic airway devices have increasingly been used as the airway technique of choice in laparoscopic surgeries. This study compared the efficacy and safety of the Baska Mask with endotracheal tube (ETT) in patients undergoing elective laparoscopic cholecystectomy.Research design and methods: This single-center, prospective, randomized controlled trial recruited 60 patients aged 18-75 years with American Society of Anesthesiologists' classifications I to III. The time taken to achieve effective airway, number of attempts, ease of insertion, ventilation parameters, hemodynamics data, and pharyngolaryngeal complications were recorded. Results: The time taken to achieve effective airway was shorter for the Baska group (26.6 ± 4.7 vs. 47.2 ± 11.8 s; p < 0.001), although the first-time insertion success rate was ≥90% for both groups. The ETT group experienced more pharyngolaryngeal complications, including cough, trauma, spasm, dysphonia, and sore throat, during device insertion and removal and had higher systolic and diastolic blood pressures during intubation (p = 0.001). The Baska Mask achieved significantly lower peak airway pressure (p = 0.024) with stable oropharyngeal leak pressure ≥33 cmH2O throughout the surgery.Conclusions: The Baska Mask is a suitable alternative to endotracheal intubation in selected patients undergoing laparoscopic cholecystectomy, with shorter insertion times, fewer perioperative complications, and improved ventilatory performance and hemodynamic response.Trial registration: The trial is registered at ClinicalTrials.gov (NCT03045835), 8 February 2017.