Study on the Risk and Severity of Jaw Clenching Caused by Sugammadex During Muscle Relaxation Reversal in Adults Undergoing Surgery

What this Trial Is About

Researchers are evaluating the occurrence, severity, and risk factors of mouth clenching caused by sugammadex during the reversal of neuromuscular blockade in adult surgical patients. This prospective, randomized, double-blind clinical trial includes adults aged 19 to 70 years undergoing elective surgery with general anesthesia using rocuronium. The study aims to improve perioperative safety by identifying factors that may increase the risk of clenching and to guide safer use of reversal agents. Participants are randomly assigned to one of four groups receiving sugammadex at doses of 1 mgkg, 2 mgkg, or 4 mgkg intravenously, or a combination of pyridostigmine and glycopyrrolate as a control. Clenching events are monitored within 10 minutes after drug administration using clinical observation, masseter muscle electromyography, and airway pressure measurements. Severity of clenching is graded on a new five-level scale, and other outcomes such as time to muscle recovery and bispectral index at clenching onset are also assessed. During the study, participants undergo neuromuscular blockade reversal under anesthesia. Researchers record clenching incidence, severity, airway pressures, and possible complications shortly after reversal. Risk factors including dose, sex, age, body mass index, and muscle relaxant dose are analyzed. The primary outcome is the incidence of clenching within 10 minutes post-reversal, with secondary outcomes capturing detailed clinical and physiological data. The study is conducted under double-blind conditions with careful monitoring to enhance understanding of sugammadex-related events.

Sugammadex-Induced Clenching During Neuromuscular Blockade Reversal