sugammadex-induced clenching during neuromuscular blockade reversal

Conditions: Neuromuscular Blockade Reversal Agent; Perioperative Complications; Anesthesia, General; Sugammadex; Monitoring, Intraoperative; Masseter Muscle Spasm

Summary: 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 18-70 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.

this prospective, randomized, double-blind clinical trial aims to investigate the incidence, risk factors, and clinical implications of sugammadex-induced clenching during neuromuscular blockade reversal under general anesthesia. sugammadex, a selective relaxant binding agent, is widely used for the rapid reversal of rocuronium-induced neuromuscular blockade. however, reports of jaw clenching and masseter muscle contraction following sugammadex administration have raised safety concerns, particularly regarding airway management and patient discomfort during emergence from anesthesia. a total of 240 adult patients (asa physical status i-ii, aged 18 to 70 years) scheduled for elective surgery under general anesthesia with rocuronium will be enrolled. participants will be randomly assigned to one of four groups in a 1:1:1:1 ratio: sugammadex 1 mg/kg (s1), 2 mg/kg (s2), 4 mg/kg (s4), or pyridostigmine 0.2 mg/kg with glycopyrrolate 0.01 mg/kg (pg) as the control. clenching events will be assessed within 10 minutes of drug administration using three criteria: visible jaw clenching, increased masseter electromyographic (emg) activity (\>50 μv for ≥2 seconds), and a rise in airway pressure (\>5 cm h₂o). severity will be graded using a novel five-level classification system. secondary outcomes include the severity and timing of clenching, time to train-of-four (tof) ratio ≥0.9, bispectral index (bis) value at the time of clenching onset, airway-related complications, and risk factor analysis based on dose, sex, bis, age, bmi, and total rocuronium dose. p"this study hypothesizes a dose-dependent increase in clenching with higher doses of sugammadex, potentially with a higher incidence in female patients and those with higher bis values at reversal."

Eligibility criteria:
inclusion criteria: * 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: * 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.

Keywords: sugammadex mouth clenching neuromuscular blockade reversal