Effect of Neuromuscular Blockade on Video Laryngeal Mask Airway Ventilation
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age20-65
SponsorKorea University Guro Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Symptoms or signs of upper respiratory tract infection
Increased risk of pulmonary aspiration
Anticipated difficult airway
Limited mouth opening (<3 cm)
Trial design
Design model
Parallel
Treatments tested in this trial
Normal Saline (Rocuronium 0 mg/kg)
Other interventionNormal saline is administered intravenously as the control study drug before video LMA insertion.
Rocuronium 0.3 mg/kg
DrugRocuronium 0.3 mg/kg (1 × ED95) is administered intravenously before video LMA insertion.
Rocuronium 0.6 mg/kg
DrugRocuronium 0.6 mg/kg (2 × ED95) is administered intravenously before video LMA insertion.
Treatment groups
96 Participants
are divided into 3 treatment groupsGroup A: 0 × ED95 GroupActive comparator 1 intervention
Group B: 1 × ED95 GroupActive comparator 1 intervention
Group C: 2 × ED95 GroupActive comparator 1 intervention
Trial outcomes
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.
Time frame
5 minutes after successful video LMA insertionSecondary outcomes
1
Oropharyngeal Leak Pressure at Later Time Points
Time frame
15 and 30 minutes after successful video LMA insertion2
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 minutes3
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 minutes4
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 insertionLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Korea University Guro Hospital
Lead sponsor
Korean Society for Airway Management
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: