Pharmacokinetics and Pharmacodynamics of Sugammadex Dosed by Corrected Body Weight for Reversal of Vecuronium in Obese Patients
Abstract
Background Dosing in obese individuals is complicated by obesity-related pathophysiological changes and deserves further investigation. Objective This study aimed to find out the influence of obesity on pharmacokinetics (PK) and pharmacodynamics (PD) of sugammadex dosed by corrected body weight (CBW) with different body mass index (BMI). Methods This prospective observational cohort study included 48 patients, who were divided into non-obese, obese, and morbidly obese groups ( n = 16 per group). At the end of laparoscopic surgical procedures, each patient received 2 mg/kg sugammadex dosed by CBW to reverse vecuronium-induced moderate neuromuscular blockade (NMB) monitored by train-of-four (TOF) setting a primary efficacy of TOF ratio to ≥ 0.9. Blood samples were collected at 2, 3, 5, 10, 15, 20, 30, 60, 120, 240, 360 and 480 min after administering sugammadex. Finally, concentration of sugammadex was identified using ultra-high-performance liquid chromatography-tandem mass spectrometry (UHPLC-MS) and PK parameters of sugammadex were calculated using Phoenix WinNonLin software. Results PK and PD data were obtained from 48 patients. C max , T max , t 1/2β , AUC 0−t , and AUC 0−∞ were significantly different between non-obese and the other two groups ( P P > 0.05). Moreover, the average times to recover from moderate NMB in non-obese, obese and morbidly obese groups were 178 ± 7.52 s, 200 ± 13.2 s and 226 ± 19.9 s respectively and did not significantly differ among three groups ( P > 0.05). Conclusion This study served as supplement to PK and PD of sugammadex in patients with different BMI and demonstrated sugammadex of 2 mg/kg dosed by CBW efficiently reversed vecuronium-induced moderate NMB in obese or morbidly obese patients although some of PK parameters changed with different BMI. Trial Registration: The study was registered prior to patient enrollment at clinicaltrials.gov (NCT05328778; principal investigator: Bo Xu; first submitted on 4 March 2022).
Abstract as supplied by the indexing source. © the authors / publisher.