Comparing the Clinical Performance of BlockBuster vs Proseal-LMA in Unparalysed Patients Undergoing General Anesthesia

This prospective, randomised single-blinded study, was conducted at the operation theatre of Universiti Kebangsaan Malaysia Medical Centre (UKMMC), following approval from the Institutional Ethics Committee of Universiti Kebangsaan Malaysia (UKM). The recruited patients were within the age range of 19 to 78 years, classified as American Society of Anesthesiologists Physical Status (ASA) class I or II, and underwent elective surgery under general anesthesia that required supraglottic airway (SGA) insertion. Exclusion criteria included a body mass index (BMI) over 35 kg/m2, limited mouth opening of less than two finger breath of inter-dental gap, edentulous, loose teeth, airway abnormalities, risk of aspiration, and known allergies to fentanyl and propofol.

During the pre-operative visit, patients were briefed about the study, and written informed consent was obtained. All recruited patients were fasted for at least 6 hours before the scheduled operation. No premedication was administered. Patients were then randomly assigned to either Group A (Blockbuster) or Group B (Proseal-LMA) using simple randomisation. SGA insertion was performed by a single operator with more than five years of experience using the Proseal-LMA and had received training using Blockbuster on a mannequin and successfully inserted it in 20 patients .

In the operation theatre, minimal standard monitoring was applied and followed by preoxygenation for three minutes. Anesthesia induction was conducted using intravenous (IV) fentanyl of 2 mcg/kg and IV propofol of 2 to 2.5 mg/kg. Additional propofol boluses of 10 to 20 mg were administered if anesthesia was inadequate and the doses were documented. Neuromuscular relaxant was not used. After achieving unconsciousness, mask ventilation was initiated with an oxygen and sevoflurane mixture until a Minimum Alveolar Concentration (MAC) of 1.3 was achieved. The depth of anesthesia was assessed by pupillary size and jaw relaxation prior to SGA insertion. The appropriate size of the SGA was chosen based on the manufacturer's recommendation according to the patient's body weight. Before SGA insertion, lubrication was applied to the outer cuff with a water-based lubricant and the cuff was fully deflated.

An assigned assistant recorded the number of attempts and time taken for successful insertion. The time taken for SGA insertion was measured from the moment SGA passes the patient's front incisor until the appearance of the first end-tidal CO2 (ETCO2) waveform on the capnography. The measurement of time was stopped and reset for subsequent attempts. The investigator inserted the BlockBuster in Group A patients and the Proseal-LMA in Group B patients. The Proseal-LMA is a reusable device and the items that used in this study was used less than 10 times previously. After SGA insertion, the cuff was inflated to a pressure of 60 cmH2O using a cuff pressure manometer. Successful insertion was determined by these three findings: chest expansion, no audible leak detected during manual bagging and the appearance of square wave capnograph tracing with ventilation generating expiratory tidal volumes of 6 to 8 ml/kg with an oxygen flow of 6 litre/min, adjustable pressure-limiting (APL) valve closed at 30 cmH2O. An audible leak was determined by listening at the mouth or lateral thyroid cartilage using a stethoscope for audible noise.

Following successful SGA insertion, a gastric tube sized 12 or 14 Fr was inserted. Oropharyngeal leak pressure (OLP) was assessed by setting the APL valve of the circle system at 30 cmH2O with a fresh gas flow of 3L/min. The OLP was determined by observing the airway pressure at equilibrium until an audible noise was heard over the mouth with a stethoscope. For safety reasons, the OLP was kept below 40 cmH2O and pressure was recorded.