BACKGROUND: The ProSeal laryngeal mask airway (PLMA) is a new laryngeal mask device with a larger cuff and a drainage tube. This study was designed to assess the usefulness and the safety of the PLMA in a laparoscopic cholecystectomy. METHODS: Forty patients undergoing a laparoscopic cholecystectomy were randomly allocated to two groups; an endotracheal tube (ETT) group or a PLMA group. Anesthesia was induced with intravenous fentanyl and propofol and maintained with TCI-propofol. Blood pressure, heart rate, peak inspiratory pressure, peripheral O2 saturation (SpO2), end-tidal CO2 tension (PETCO2) and PaCO2 was measured during the operation. The incidence of gastric content regurgitation and gross pulmonary aspiration were evaluated. Postoperatively, SpO2, the visual analogue scale (VAS) of pain, nausea and vomiting (PONV), and sore throat were evaluated at 30 minutes intervals in post-anesthetic care unit (PACU) and at night. RESULTS: There were no significant differences in intraoperative PIP, SpO2, PETCO2, postoperative SpO2, VAS scores, PONV, and sore throat between the two groups. Gross pulmonary aspiration was not found in either group, but minimal gastric regurgitation occurred in 2 cases of the ETT group and 1 case of the PLMA group. CONCLUSIONS: We concluded that there were no differences in patient safety and adequate ventilation for a laparoscopic cholecystectomy between the ETT group and PLMA group. Moreover, there were no increases in blood pressure and heart rate in PLMA group during insertion/intubation.