Effect of Neuromuscular Blockade on Video Laryngeal Mask Airway Ventilation

Phase 4Not Yet RecruitingNCT07828977

Korea University Guro Hospital96 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Airway Management Neuromuscular Blockade General Anesthesia

Interventions

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Oropharyngeal Leak Pressure (OLP)

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.

Time frame: 5 minutes after successful video LMA insertion

Secondary Outcomes

Oropharyngeal Leak Pressure at Later Time Points

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

Number of LMA Insertion Attempts

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.

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

LMA Insertion Time

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

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

Laryngeal View Grade

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.

Time frame: Immediately after successful video LMA insertion

Neuromuscular Blockade at 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.

Time frame: Immediately before video LMA insertion

Number of Participants With Sore Throat, Hoarseness, and Dysphagia

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

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