Video Laryngeal Mask Versus Endotracheal Tube Undergoing Laparoscopic Cholecystectomy Surgery

May 17, 2026 updated by: Seoul National University Hospital

Video Laryngeal Mask Versus Endotracheal Tube in Patients Undergoing Laparoscopic Cholecystectomy Surgery Under General Anesthesia: a Prospective Randomized Controlled Trial

The aim of this study is to investigate the effectiveness of using a video laryngeal mask for airway management in patients undergoing laparoscopic cholecystectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators will compare the time required to secure the airway when inserting a video laryngeal mask (LMA) versus performing endotracheal intubation.

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Seoul, South Korea, 03080
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients over 19 years old
  • Patients planned for elective laparoscopic cholecystectomy

Exclusion Criteria:

  • High risk of aspiration (e.g. gastro-esophageal reflux disease, hiatus hernia, pregnancy, history of gastrectomy)
  • Difficult airway (e.g. limitation of mouth opening, limitation of neck extension, oropharyngeal pathology)
  • Obesity (BMI > 30 kg/m2)
  • Tooth mobility

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Video LMA
The airway is secured with a video laryngeal mask airway (VLMA).
Device: Video laryngeal mask airway
The airway is secured with a video laryngeal mask airway.
Active Comparator: Control
The participant is intubated with an endotracheal tube via direct laryngoscopy.
Device: Endotracheal tube
The participant is intubated with an endotracheal tube via direct laryngoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time required for VLMA insertion or intubation
Time Frame: After induction of anesthesia, before the operation starts.
Time required for VLMA insertion or intubation
After induction of anesthesia, before the operation starts.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of trials
Time Frame: After induction of anesthesia, before the operation starts.
Video laryngeal mask airway insertion or endotracheal intubation
After induction of anesthesia, before the operation starts.
Postoperative sore throat
Time Frame: 1 hour after end of operation
4-point scale, 0 = no sore throat; 1 = mild sore throat (complaints of sore throat only on asking); 2 = moderate sore throat (complaints of sore throat on his/her own); 3 = severe sore throat (change of voice or hoarseness, associated with throat pain)
1 hour after end of operation
Postoperative sore throat
Time Frame: 24 hours after end of operation
4-point scale, 0 = no sore throat; 1 = mild sore throat (complaints of sore throat only on asking); 2 = moderate sore throat (complaints of sore throat on his/her own); 3 = severe sore throat (change of voice or hoarseness, associated with throat pain)
24 hours after end of operation
Postoperative hoarseness
Time Frame: 1 hour after end of operation
4-point scale, 0 = no hoarseness; 1 = mild hoarseness (complaints of hoarseness only on asking); 2 = moderate hoarseness (complaints of hoarseness on his/her own); 3 = severe hoarseness (hoarseness associated with throat pain)
1 hour after end of operation
Postoperative hoarseness
Time Frame: 24 hours after end of operation
4-point scale, 0 = no hoarseness; 1 = mild hoarseness (complaints of hoarseness only on asking); 2 = moderate hoarseness (complaints of hoarseness on his/her own); 3 = severe hoarseness (hoarseness associated with throat pain)
24 hours after end of operation
Peak airway pressure
Time Frame: After video laryngeal mask airway insertion or intubation, before extubation
Peak airway pressure
After video laryngeal mask airway insertion or intubation, before extubation
Minute ventilation
Time Frame: After video laryngeal mask airway insertion or intubation, before extubation
Minute ventilation
After video laryngeal mask airway insertion or intubation, before extubation
End tidal carbon dioxide
Time Frame: After video laryngeal mask airway insertion or intubation, before extubation
End tidal carbon dioxide
After video laryngeal mask airway insertion or intubation, before extubation
Oropharyngeal leak pressure
Time Frame: After video laryngeal mask airway insertion or intubation, before extubation
Oropharyngeal leak pressure
After video laryngeal mask airway insertion or intubation, before extubation
Traces of blood on airway device after extubation
Time Frame: After extubation, before transfer to PACU
Traces of blood on airway device after extubation
After extubation, before transfer to PACU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Hansol KIM, MD, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2024

Primary Completion (Actual)

April 6, 2026

Study Completion (Actual)

April 7, 2026

Study Registration Dates

First Submitted

June 27, 2024

First Submitted That Met QC Criteria

July 8, 2024

First Posted (Actual)

July 15, 2024

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 17, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2308-160-1461

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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