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Clinical Trials/NCT06395922
NCT06395922
Recruiting
Not Applicable

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

Tanta University1 site in 1 country140 target enrollmentFebruary 6, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Blockbuster LMA
Sponsor
Tanta University
Enrollment
140
Locations
1
Primary Endpoint
Oropharyngeal leak pressure
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 6, 2024
End Date
June 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rabab Mohamed Mohamed Mohamed

Assistant Professor of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt

Tanta University

Eligibility Criteria

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.
  • Pregnancy.
  • Patients taking rate-controlling medications, steroids, opioids, or regular antacids.

Outcomes

Primary Outcomes

Oropharyngeal leak pressure

Time Frame: 30 min after insertion

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

Secondary Outcomes

  • Device insertion time(5 min after insertion)
  • Complications(24 hours postoperatively)
  • The incidence of successful gastric tube placement(10 min after insertion)

Study Sites (1)

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