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Blockbuster LMA Versus Baska Mask in Laparoscopic Cholecystectomy

Blockbuster LMA Versus Baska Mask in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Clinical Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06395922
Enrollment
140
Registered
2024-05-02
Start date
2024-02-06
Completion date
2024-06-01
Last updated
2024-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blockbuster LMA, Baska Mask, Laparoscopic Cholecystectomy

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.

Interventions

DEVICEBlockbuster 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)

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

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Oropharyngeal leak pressure30 min after insertionOropharyngeal leak pressure was measured Just after insertion and 30 min after insertion.

Secondary

MeasureTime frameDescription
Device insertion time5 min after insertionThe time from start of insertion till successful insertion.
The incidence of successful gastric tube placement10 min after insertionThe incidence of successful gastric tube placement through the device.
Complications24 hours postoperativelyComplications such as including pain in the throat, difficulty in swallowing, cough, and blood on the device were measured.

Countries

Egypt

Contacts

Primary ContactRabab M Mohamed, MD
rabmoh_30@outlook.com00201069122935

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026