Conditions: Anesthesia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 100
Healthy volunteers: no

Brief summary:
The primary purpose of this study is to compare the incidence of

residual neuromuscular blockade at the time of tracheal extubation after reversal of rocuronium bromide-induced neuromuscular blockade by 4 mg/kg sugammadex with that of 50 µg/kg neostigmine. Residual neuromuscular blockade is defined as the fourth twitch to first twitch (T4/T1) ratio of

\< 0.90.

Detailed description:
Undetected residual neuromuscular blockade is common in the post-anesthesia care

unit (PACU). In fact, 16%-42% of patients receiving intermediate-acting muscle

relaxants in the operating room have T4/T1 ratios \<0.7-0.8 in the PACU. Respiratory and pharyngeal muscle function can be adversely affected during minimal neuromuscular blockade. Studies in awake volunteers and surgical patients have demonstrated that T4/T1 ratios of 0.7 - 0.9 are associated with impaired airway protective reflexes, upper airway obstruction, a decreased hypoxic ventilatory response, and post-operative hypoxemia. The incidence and severity of residual neuromuscular blockade at the time of tracheal extubation will be evaluated to determine how these influence the length of stay in the operating room and PACU.

Arms:
arm 1: 4 mg/kg sugammadex arm 2: 50 µg/kg neostigmine

Interventions: intervention 1: Sugammadex intervention 2: Neostigmine intervention 3: Rocuronium
Intervention descriptions: intervention 1: Participants received 4 mg/kg sugammadex at 1-2 Post Tetanic Counts (PTCs) or better after the last dose of rocuronium bromide. intervention 2: Participants received 50 µg/kg neostigmine combined with 10 µg/kg glycopyrrolate after the last dose of rocuronium bromide as per standard of care. intervention 3: Participants received a single intubation bolus dose of 0.6 mg/kg rocuronium bromide, followed if necessary to maintain neuromuscular blockade by one or more single bolus dose(s) of 0.15 mg/kg rocuronium bromide.

Protocol document: