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NCT07894029
Effect of Neuromuscular Blocking Agent Use on Video Laryngeal Mask Airway Insertion
Conditions: Airway Management, Supraglottic Airway Device Insertion, Laryngeal Mask Airways, Anesthesia, General, Neuromuscular Blockade
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 128
Sponsor: Hacettepe University
Location: Hacettepe University Faculty of Medicine Hospital Ankara Ankara
Summary
This study aims to investigate whether the administration of a neuromuscular blocking agent (rocuronium) improves the anatomical positioning of a third-generation video laryngeal mask airway (video LMA) in adult patients undergoing elective surgery under general anesthesia.
A laryngeal mask airway is a device placed in the throat to maintain an open airway and support ventilation during general anesthesia. The third-generation video LMA incorporates a camera that allows the anesthesiologist to visualize the laryngeal structures and assess device positioning during insertion. Neuromuscular blocking agents reduce muscle tone and may facilitate airway device insertion. However, their potential benefits for the positioning and performance of video LMAs remain unclear.
This is a prospective, randomized, controlled, parallel-group, outcome assessor-blinded clinical trial. Eligible patients will be randomly assigned to one of two groups. Both groups will receive propofol and remifentanil for anesthesia induction. The intervention group will additionally receive rocuronium (0.6 mg/kg), while the control group will receive no neuromuscular blocking agent.
The primary outcome is the proportion of patients achieving optimal anatomical positioning of the video LMA, defined as a Brimacombe score of 4 on the integrated video image. Secondary outcomes include oropharyngeal leak pressure, insertion time, first-attempt insertion success, number of insertion attempts, ease of insertion, hemodynamic changes, ventilation parameters, airway-related complications, and postoperative adverse effects.
Eligibility Criteria
Inclusion Criteria:
* Age 18-80 years
* American Society of Anesthesiologists (ASA) physical status I-II
* Scheduled for elective surgery under general anesthesia
* Planned airway management with a laryngeal mask airway (LMA)
* Written informed consent
Exclusion Criteria:
* Predicted difficult airway based on preoperative anesthesia assessment, defined as any of the following:
* Mallampati class III-IV
* Upper lip bite test class III
* Short thyromental or sternomental distance
* Micrognathia or retrognathia
* Mouth opening less than 3 cm
* Body mass index (BMI) \>35 kg/m²
* Emergency surgery
Source: ClinicalTrials.gov (NCT07894029). StuddyBuddy aggregates publicly available trial information.