Blockbuster LMA Versus Baska Mask in Laparoscopic Cholecystectomy

Not Applicable

Recruiting

• Conditions: Baska Mask; Laparoscopic Cholecystectomy; Blockbuster LMA
• Interventions: Device: Blockbuster LMA; Device: Baska Mask

• Registration Number: NCT06395922
• Lead Sponsor: Tanta University

Brief Summary

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).

Detailed 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.

Study Timeline

• Study Start: 2024-02-06
• Study First Submitted: 2024-04-27
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-01
• Last Update Submitted: 2024-05-01
• Study First Posted: 2024-05-02
• Last Update Posted: 2024-05-02
• Primary Completion: 2024-06-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blockbuster LMA (Group BL)	Blockbuster LMA	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).
Baska Mask (Group BM)	Baska Mask	The BM was inserted by opening the mouth, avoiding the tongue, and negotiating the palatopharyngeal curve using the hand-tab.

Primary Outcome Measures

Name	Time	Method
Oropharyngeal leak pressure	30 min after insertion	Oropharyngeal leak pressure was measured Just after insertion and 30 min after insertion.

Secondary Outcome Measures

Name	Time	Method
Complications	24 hours postoperatively	Complications such as including pain in the throat, difficulty in swallowing, cough, and blood on the device were measured.
Device insertion time	5 min after insertion	The time from start of insertion till successful insertion.
The incidence of successful gastric tube placement	10 min after insertion	The incidence of successful gastric tube placement through the device.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt