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NCT Number: NCT07828977

Effect of Neuromuscular Blockade on Video Laryngeal Mask Airway Ventilation

This prospective, randomized, double-blind study aims to evaluate the effect of different degrees of neuromuscular blockade on the performance of a video laryngeal mask airway (LMA) during general anesthesia. Participants will be randomly assigned to receive rocuronium at 0, 0.3, or 0.6 mg/kg, corresponding to 0, 1, or 2 times the ED95, respectively. The primary outcome is oropharyngeal leak pressure measured after LMA insertion. Secondary outcomes include LMA insertion conditions, insertion time and number of attempts, laryngeal view, respiratory parameters, and postoperative airway-related complications.

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Key information

Conditions

Airway Management General Anesthesia Neuromuscular Blockade

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Scheduled for elective surgery under general anesthesia with a video
  • laryngeal mask airway
  • Expected duration of surgery less than 3 hours
  • Surgery performed in the supine position
  • Provision of written informed consent

Exclusion criteria

  • Symptoms or signs of upper respiratory tract infection
  • Increased risk of pulmonary aspiration
  • Anticipated difficult airway
  • Limited mouth opening (<3 cm)
  • Limited head or neck movement
  • Mallampati class IV
  • Body mass index ≥35 kg/m²

Treatment and study plan

Normal Saline (Rocuronium 0 mg/kg)

Other

Normal saline is administered intravenously as the control study drug before video LMA insertion.

Rocuronium 0.3 mg/kg

Drug

Rocuronium 0.3 mg/kg (1 × ED95) is administered intravenously before video LMA insertion.

Rocuronium 0.6 mg/kg

Drug

Rocuronium 0.6 mg/kg (2 × ED95) is administered intravenously before video LMA insertion.

Primary outcomes

  1. Oropharyngeal Leak Pressure (OLP)

    Time frame: 5 minutes after successful video LMA insertion

    Oropharyngeal leak pressure will be measured 5 minutes after successful video LMA insertion and compared among the three neuromuscular blockade groups. OLP is expressed in cmH2O.

Secondary outcomes

  1. Oropharyngeal Leak Pressure at Later Time Points

    Time frame: 15 and 30 minutes after successful video LMA insertion

  2. Number of LMA Insertion Attempts

    Time frame: During anesthetic induction before surgery, assessed for up to 5 minutes

    The number of attempts required for successful video LMA insertion will be recorded. A maximum of two insertion attempts is permitted. Failure will be recorded if successful insertion is not achieved after two attempts.

  3. LMA Insertion Time

    Time frame: During anesthetic induction before surgery, assessed for up to 5 minutes

    LMA insertion time will be measured in seconds from mouth opening to confirmation of the first capnographic waveform.

  4. Laryngeal View Grade

    Time frame: Immediately after successful video LMA insertion

    The laryngeal view obtained through the video LMA will be graded on a 4-point scale. The need for real-time adjustment and any change in laryngeal view after adjustment will also be recorded.

  5. Neuromuscular Blockade at LMA Insertion

    Time frame: Immediately before video LMA insertion

    Neuromuscular response will be recorded immediately before video LMA insertion using train-of-four monitoring, including TOF count and/or quantitative twitch response according to the available monitor.

  6. Number of Participants With Sore Throat, Hoarseness, and Dysphagia

    Time frame: Postoperatively in the PACU and at 24 hours after surgery

    The presence or absence of sore throat, hoarseness, and dysphagia will be assessed separately for each participant.

Study contacts

Contact information is provided by the study sponsor or research team.

Seok Kyeong Oh, MD, PhD

CONTACT

[email protected]

82-2-2626-3234

Sponsors and collaborators

Lead sponsor

Korea University Guro Hospital

Other

Collaborators

  • Korean Society for Airway Management

Registry information

Official study title

The Relationship Between the Degree of Neuromuscular Blockade and the Conditions of Laryngeal Mask Ventilation: A Prospective Randomized Double-Blind Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 18, 2026
Registry last updated
Sep 18, 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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