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Completed

NCT Number: NCT06502028

Video Laryngeal Mask Versus Endotracheal Tube Undergoing Laparoscopic Cholecystectomy Surgery

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

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Key information

Conditions

Cholecystitis Biliary Tract Diseases Digestive System Diseases Gallbladder Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Video laryngeal mask airway

Device

The airway is secured with a video laryngeal mask airway.

Endotracheal tube

Device

The participant is intubated with an endotracheal tube via direct laryngoscopy.

Primary outcomes

  1. Time required for VLMA insertion or intubation

    Time frame: After induction of anesthesia, before the operation starts.

    Time required for VLMA insertion or intubation

Secondary outcomes

  1. Number of trials

    Time frame: After induction of anesthesia, before the operation starts.

    Video laryngeal mask airway insertion or endotracheal intubation

  2. Peak airway pressure

    Time frame: After video laryngeal mask airway insertion or intubation, before extubation

    Peak airway pressure

  3. Minute ventilation

    Time frame: After video laryngeal mask airway insertion or intubation, before extubation

    Minute ventilation

  4. End tidal carbon dioxide

    Time frame: After video laryngeal mask airway insertion or intubation, before extubation

    End tidal carbon dioxide

  5. Oropharyngeal leak pressure

    Time frame: After video laryngeal mask airway insertion or intubation, before extubation

    Oropharyngeal leak pressure

  6. Traces of blood on airway device after extubation

    Time frame: After extubation, before transfer to PACU

    Traces of blood on airway device after extubation

  7. 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)

  8. 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)

  9. 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)

  10. 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)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 15, 2024
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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