Airway ManagementPhase 4NCT07828977
Effect of Neuromuscular Blockade on Video Laryngeal Mask Airway Ventilation
A Phase 4 study testing Normal Saline (Rocuronium 0 mg/kg), Rocuronium 0.3 mg/kg and Rocuronium 0.6 mg/kg in people with Airway Management and Neuromuscular Blockade, run by Korea University Guro Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Airway Management, Neuromuscular Blockade, General Anesthesia
- What is being tested?
- Normal Saline (Rocuronium 0 mg/kg), Rocuronium 0.3 mg/kg and Rocuronium 0.6 mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 7 Sep 2026to 30 Aug 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Being tested
- Normal Saline (Rocuronium 0 mg/kg), Rocuronium 0.3 mg/kg, Rocuronium 0.6 mg/kg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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/kgDrug
Rocuronium 0.3 mg/kg (1 × ED95) is administered intravenously before video LMA insertion.
Rocuronium 0.6 mg/kgDrug
Rocuronium 0.6 mg/kg (2 × ED95) is administered intravenously before video LMA insertion.
| Study group | Role | What they receive |
|---|---|---|
| 0 × ED95 Group | Active comparator | Participants receive rocuronium 0 mg/kg (0 × ED95) before video LMA insertion. Receives: 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. Receives: Drug: Rocuronium 0.3 mg/kg |
| 2 × ED95 Group | Active comparator | Participants receive rocuronium 0.6 mg/kg (2 × ED95) before video LMA insertion. Receives: Drug: Rocuronium 0.6 mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 minutes after successful video LMA insertion
Secondary outcomes (6)
Oropharyngeal Leak Pressure at Later Time Points
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Postoperatively in the PACU and at 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start7 Sep 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korean Society for Airway Management
- Responsible party
- Principal investigator, Seok Kyeong Oh, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828977
- Sponsor's protocol ID
- 2026GR0199
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No