Study Objective:
This study aims to evaluate the incidence, severity, and risk factors of sugammadex-induced mouth clenching during neuromuscular blockade (NMB) reversal in adult surgical patients.
Study Design:
This prospective, randomized, double-blind, controlled clinical trial enrolls adult patients (ASA physical status I-II, aged 19-70 years) undergoing elective surgery under general anesthesia with rocuronium. Patients will be randomized into four groups to receive either sugammadex at doses of 1 mg/kg, 2 mg/kg, or 4 mg/kg, or a combination of pyridostigmine and glycopyrrolate.
Primary Outcome:
The primary outcome is the incidence of clenching within 10 minutes after NMB reversal, assessed by clinical observation, masseter EMG, and airway pressure changes, using a novel five-grade severity scale.
Secondary Outcomes:
Secondary outcomes include the severity of clenching, time to TOF ratio ≥0.9, BIS values at clenching onset, complications, and identification of risk factors such as dose, sex, BIS, age, BMI, and rocuronium dose.
Significance:
This study seeks to improve perioperative safety by identifying modifiable risk factors and informing dose adjustments or alternative reversal strategies to prevent sugammadex-induced clenching, particularly in high-risk populations.
Eligible participants are adults aged 19-70 years, American Society of Anesthesiologists (ASA) physical status I-II, undergoing elective surgery under general anesthesia with rocuronium.
Exclusion criteria include neuromuscular disorders, renal impairment (creatinine clearance < 30 mL/min), history of clenching or dental disease, allergy to study drugs, or emergency surgery.
Parallel
Sugammadex 1 mg/kg Group
DrugParticipants receive 1 mg/kg of sugammadex intravenously for reversal of rocuronium-induced neuromuscular blockade.
Sugammadex 2 mg/kg Group
DrugParticipants receive 2 mg/kg of sugammadex intravenously for reversal of rocuronium-induced neuromuscular blockade.
Sugammadex 4 mg/kg Group
DrugParticipants receive 4 mg/kg of sugammadex intravenously for reversal of rocuronium-induced neuromuscular blockade.
Pyridostigmine/Glycopyrrolate Group
DrugParticipants receive pyridostigmine 0.2 mg/kg and glycopyrrolate 0.01 mg/kg intravenously for reversal of rocuronium-induced neuromuscular blockade.
Incidence of Mouth Clenching After Neuromuscular Blockade Reversal
Clenching is defined as any of the following occurring within 10 minutes after administration of neuromuscular blockade reversal agents: (1) visible jaw clenching observed by the anesthesiologist, (2) masseter muscle electromyography (EMG) activity greater than 50 μV sustained for ≥2 seconds, or (3) airway pressure increase \>5 cm H₂O.
Severity of Mouth Clenching
Graded using a novel five-grade severity scale based on degree of jaw closure, EMG intensity, airway pressure, and need for intervention.
Time to Recovery of Train-of-Four (TOF) Ratio ≥0.9
Measured using peripheral nerve stimulator; defined as time from reversal agent injection to TOF ratio ≥0.9.
Bispectral Index (BIS) at Clenching Onset
BIS value recorded at the time clenching is first detected.
Peak Airway Pressure
Maximum airway pressure measured within 10 minutes after administration of reversal agent.
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