Blockbuster LMA Versus Baska Mask in Laparoscopic Cholecystectomy

NCT06395922 | Recruiting

• 1 other identifier: 36264PR526/2/24
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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).

Conditions

Blockbuster LMA; Baska Mask; Laparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (1)

• Oropharyngeal leak pressure

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

  30 min after insertion

Secondary Outcomes (3)

• Device insertion time

  5 min after insertion

• The incidence of successful gastric tube placement

  10 min after insertion

• Complications

  24 hours postoperatively

Study Arms (2)

Blockbuster LMA (Group BL)

EXPERIMENTAL

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).

Device: Blockbuster LMA

Baska Mask (Group BM)

EXPERIMENTAL

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

Device: Baska Mask

Interventions

Blockbuster LMA DEVICE

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)

Blockbuster LMA (Group BL)

Baska Mask DEVICE

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

Baska Mask (Group BM)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

Central Study Contacts

Rabab M Mohamed, MD

CONTACT

00201069122935; rabmoh_30@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt

Study Record Dates

• First Submitted: April 27, 2024
• First Posted: May 2, 2024
• Study Start: February 6, 2024
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: May 2, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)