Blockbuster LMA Versus Baska Mask in Laparoscopic Cholecystectomy

Tanta University

Status: Enrolling

Conditions: Baska Mask; Laparoscopic Cholecystectomy; Blockbuster LMA

Treatments: Device: Baska Mask; Device: Blockbuster LMA

Study type: Interventional

Funder types: Other

Identifiers

NCT06395922

36264PR526/2/24

Details and patient eligibility

About

This study aimed to compare the performance and safety profiles of two supraglottic airway devices (SADs), the Blockbuster laryngeal mask airway (LMA) and the Baska Mask (BM), in patients underwent laparoscopic cholecystectomy (LC).

Full description

Laparoscopic surgery has become increasingly prevalent across numerous surgical disciplines due to the well-established benefits it offers over traditional open procedures. Laparoscopic cholecystectomy (LC), the surgical removal of the gallbladder, stands out as one of the most frequently performed laparoscopic operations worldwide.

Supraglottic airway devices (SADs) play a crucial role in airway management algorithms, serving as viable alternatives in both anticipated and unanticipated difficult airway situations.

The laryngeal mask airway (LMA) can be utilized to establish a routine airway during general anesthesia or, less frequently, as a conduit for tracheal intubation. Newer, improved LMA designs incorporate cuffs that provide higher sealing pressures than classic LMAs, while also allowing for the venting of gastric contents through a dedicated drain tube.

The Baska Mask (BM), a second-generation SAD, features a non-inflatable cuff that is continuous with the airway channel, thereby inflating with positive pressure ventilation to improve cuff seal.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18-60 years
• Both sexes.
• American Society of Anesthesiologists (ASA) physical status I-II.
• Scheduled for elective LC under general anesthesia.

Exclusion criteria

• Anticipated difficult airway.
• Renal dysfunction.
• Hiatus hernia.
• Obesity.
• Pregnancy.
• Patients taking rate-controlling medications, steroids, opioids, or regular antacids.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Blockbuster LMA (Group BL)

Experimental group

Description:

The LMA was inserted using the recommended technique, with the patient's head in the sniffing position. The appropriate size was selected based on body weight (size 3 for 30-50 kg, size 4 for 50-70 kg).

Treatment:

Device: Blockbuster LMA

Baska Mask (Group BM)

Experimental group

Description:

The BM was inserted by opening the mouth, avoiding the tongue, and negotiating the palatopharyngeal curve using the hand-tab.

Treatment:

Device: Baska Mask