Blockbuster LMA Versus Baska Mask in Laparoscopic Cholecystectomy

Laparoscopic Cholecystectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06395922
• Other study ID #: 36264PR526/2/24
• Status: Recruiting
• Phase: N/A
• Start date: February 6, 2024
• Est. completion date: June 1, 2024

Study information

• Verified date: May 2024
• Source: Tanta University
• Contact: Rabab M Mohamed, MD
• Phone: 00201069122935
• Email: rabmoh_30[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Baska Mask
• Laparoscopic Cholecystectomy

Intervention

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

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta	El-Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oropharyngeal leak pressure	Oropharyngeal leak pressure was measured Just after insertion and 30 min after insertion.	30 min after insertion
Secondary	Device insertion time	The time from start of insertion till successful insertion.	5 min after insertion
Secondary	The incidence of successful gastric tube placement	The incidence of successful gastric tube placement through the device.	10 min after insertion
Secondary	Complications	Complications such as including pain in the throat, difficulty in swallowing, cough, and blood on the device were measured.	24 hours postoperatively