Airway Management, General Anesthesia, Neuromuscular Blockade
Conditions
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.
Interventions
OTHERNormal Saline (Rocuronium 0 mg/kg)
Normal saline is administered intravenously as the control study drug before video LMA insertion.
Rocuronium 0.3 mg/kg (1 × ED95) is administered intravenously before video LMA insertion.
Rocuronium 0.6 mg/kg (2 × ED95) is administered intravenously before video LMA insertion.
Sponsors
Korea University Guro Hospital
Korean Society for Airway Management
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oropharyngeal Leak Pressure (OLP) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| LMA Insertion Time | 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. |
| Laryngeal View Grade | 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. |
| Neuromuscular Blockade at LMA Insertion | 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. |
| Number of Participants With Sore Throat, Hoarseness, and Dysphagia | 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. |
Contacts
CONTACTSeok Kyeong Oh, MD, PhD
Outcome results
None listed