NCT07828977

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for phase_4

Timeline
11mo left

Started Sep 2026

Shorter than P25 for phase_4

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Sep 2026Aug 2027

First Submitted

Initial submission to the registry

September 4, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

September 7, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 18, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2027

Last Updated

September 18, 2026

Status Verified

September 1, 2026

Enrollment Period

6 months

First QC Date

September 4, 2026

Last Update Submit

September 15, 2026

Conditions

Airway ManagementGeneral AnesthesiaNeuromuscular Blockade

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Oropharyngeal Leak Pressure at Later Time Points

    15 and 30 minutes after successful video LMA insertion

  • Number of LMA Insertion Attempts

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

  • LMA Insertion Time

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

  • Laryngeal View Grade

    Immediately after successful video LMA insertion

  • Neuromuscular Blockade at LMA Insertion

    Immediately before video LMA insertion

  • +1 more secondary outcomes

Study Arms (3)

0 × ED95 Group

ACTIVE COMPARATOR

Participants receive rocuronium 0 mg/kg (0 × ED95) before video LMA insertion.

Other: Normal Saline (Rocuronium 0 mg/kg)

1 × ED95 Group

ACTIVE COMPARATOR

Participants receive rocuronium 0.3 mg/kg (1 × ED95) before video LMA insertion.

Drug: Rocuronium 0.3 mg/kg

2 × ED95 Group

ACTIVE COMPARATOR

Participants receive rocuronium 0.6 mg/kg (2 × ED95) before video LMA insertion.

Drug: Rocuronium 0.6 mg/kg

Interventions

Normal Saline (Rocuronium 0 mg/kg)OTHER

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

0 × ED95 Group
Rocuronium 0.3 mg/kgDRUG

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

1 × ED95 Group
Rocuronium 0.6 mg/kgDRUG

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

2 × ED95 Group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Saline SolutionRocuronium

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsAndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Central Study Contacts

Seok Kyeong Oh, MD, PhD

CONTACT

82-2-2626-3234nanprayboy@korea.ac.kr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology

Study Record Dates

First Submitted

September 4, 2026

First Posted

September 18, 2026

Study Start

September 7, 2026

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

August 30, 2027

Last Updated

September 18, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share