Effect of Neuromuscular Blockade on Video Laryngeal Mask Airway Ventilation

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

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 Overview

• Status: Not yet recruiting
• Conditions: Airway Management; General Anesthesia; Neuromuscular Blockade
• Intervention / Treatment: Other: Normal Saline (Rocuronium 0 mg/kg); Drug: Rocuronium 0.3 mg/kg; Drug: Rocuronium 0.6 mg/kg

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Seok Kyeong Oh, MD, PhD; Phone Number: 82-2-2626-3234; Email: nanprayboy@korea.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 0 × ED95 Group; Participants receive rocuronium 0 mg/kg (0 × ED95) before video LMA insertion.	Other: Normal Saline (Rocuronium 0 mg/kg); Normal saline is administered intravenously as the control study drug before video LMA insertion.
Active Comparator: 1 × ED95 Group; Participants receive rocuronium 0.3 mg/kg (1 × ED95) before video LMA insertion.	Drug: Rocuronium 0.3 mg/kg; Rocuronium 0.3 mg/kg (1 × ED95) is administered intravenously before video LMA insertion.
Active Comparator: 2 × ED95 Group; Participants receive rocuronium 0.6 mg/kg (2 × ED95) before video LMA insertion.	Drug: Rocuronium 0.6 mg/kg; Rocuronium 0.6 mg/kg (2 × ED95) is administered intravenously before video LMA insertion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 minutes after successful video LMA insertion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oropharyngeal Leak Pressure at Later Time Points		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.	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.	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.	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.	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.	Postoperatively in the PACU and at 24 hours after surgery

Collaborators and Investigators

• Sponsor: Korea University Guro Hospital
• Collaborators: Korean Society for Airway Management

Study record dates

Study Major Dates

• Study Start (Estimated): September 7, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): August 30, 2027

Study Registration Dates

• First Submitted: September 4, 2026
• First Submitted That Met QC Criteria: September 15, 2026
• First Posted (Actual): September 18, 2026

Study Record Updates

• Last Update Posted (Actual): September 18, 2026
• Last Update Submitted That Met QC Criteria: September 15, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Preparations; Polycyclic Compounds; Steroids; Fused-Ring Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Androstanes; Androstanols; Rocuronium; Saline Solution
• Other Study ID Numbers: 2026GR0199

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