Dataset Information

Actual versus ideal body weight dosing of sugammadex in morbidly obese patients offers faster reversal of rocuronium- or vecuronium-induced deep or moderate neuromuscular block: a randomized clinical trial.

ABSTRACT:

Background

This randomized, double-blind trial evaluated sugammadex-mediated recovery time from rocuronium- or vecuronium-induced moderate (M-) or deep (D-) neuromuscular block in morbidly obese adults dosed by actual (ABW) or ideal body weight (IBW).

Methods

Adults with BMI ?40?kg/m² were randomized to 1 of 5 groups: M-neuromuscular block, sugammadex 2?mg/kg ABW; M-neuromuscular block, sugammadex 2?mg/kg IBW; M-neuromuscular block, neostigmine 5?mg, and glycopyrrolate 1?mg; D-neuromuscular block, sugammadex 4?mg/kg ABW; or D-neuromuscular block, sugammadex 4?mg/kg IBW. Supramaximal train of four (TOF) stimulation of the ulnar nerve (TOF-watch SX®) monitored recovery. Primary endpoint was time to TOF ratio???0.9 for ABW and IBW groups pooled across neuromuscular blocking agent (NMBA)/blocking depth, analyzed by log-rank test stratified for agent and depth. Prespecified safety outcomes included treatment-emergent bradycardia, tachycardia, and other arrhythmias, and adjudicated hypersensitivity and anaphylaxis.

Results

Of 207 patients randomized, 188 received treatment (28% male, BMI 47?±?5.1?kg/m², age 48?±?13?years). Recovery was 1.5?min faster with ABW vs IBW dosing. The sugammadex 2?mg/kg groups recovered 9-fold faster [time 0.11-fold, 95% CI 0.08 to 0.14] than the neostigmine group. ABW (5.3%) and IBW (2.7%) groups had similar incidences of recovery time?>?10?min (95% CI of difference: -?4.8 to 11.0%); 84% for neostigmine group. Re-curarization occurred in one patient each in the 2?mg/kg IBW and neostigmine groups. Prespecified safety outcomes occurred with similar incidences.

Conclusions

ABW-based sugammadex dosing yields faster reversal without re-curarization, supporting ABW-based sugammadex dosing in the morbidly obese, irrespective of the depth of neuromuscular block or NMBA used.

Trial registration

Registered on November 17, 2017, at ClinicalTrials.gov under number NCT03346070 .

SUBMITTER: Horrow JC

PROVIDER: S-EPMC7913453 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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Publications

Actual versus ideal body weight dosing of sugammadex in morbidly obese patients offers faster reversal of rocuronium- or vecuronium-induced deep or moderate neuromuscular block: a randomized clinical trial.

Horrow Jay C JC Li Wen W Blobner Manfred M Lombard John J Speek Marcel M DeAngelis Matthew M Herring W Joseph WJ

BMC anesthesiology 20210227 1

<h4>Background</h4>This randomized, double-blind trial evaluated sugammadex-mediated recovery time from rocuronium- or vecuronium-induced moderate (M-) or deep (D-) neuromuscular block in morbidly obese adults dosed by actual (ABW) or ideal body weight (IBW).<h4>Methods</h4>Adults with BMI ≥40 kg/m<sup>2</sup> were randomized to 1 of 5 groups: M-neuromuscular block, sugammadex 2 mg/kg ABW; M-neuromuscular block, sugammadex 2 mg/kg IBW; M-neuromuscular block, neostigmine 5 mg, and glycopyrrolate ...[more]

PMID: 33639839

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Project description:Background: Sugammadex is known to reverse neuromuscular blockade induced by non-depolarizing agents. In children, the recommended dose for reversal of moderate neuromuscular blockade is 2 mg/kg. We investigated the pharmacokinetics and pharmacodynamics of sugammadex in Korean children. Methods: Children (2-17 years of age) undergoing brain or spine surgery were enrolled and randomly assigned to control (neostigmine) and 2, 4, or 8 mg/kg sugammadex groups. Following induction of anesthesia and monitoring of the response to train-of-four stimulation, 1 mg/kg rocuronium was intravenously administered. Upon reappearance of the second twitch to train-of-four stimulation, the study drug was administered according to group allocation. The plasma concentrations of rocuronium and sugammadex were serially measured at nine predefined time points following study drug administration. To determine efficacy, we measured the time elapsed from drug administration to recovery of T4/T1 ≥ 0.9. For pharmacokinetics, non-compartmental analysis was performed and we monitored adverse event occurrence from the time of study drug administration until 24 h post-surgery. Results: Among the 29 enrolled participants, the sugammadex (2 mg/kg) and control groups showed recovery times [median (interquartile range)] of 1.3 (1.0-1.9) and 7.7 (5.3-21.0) min, respectively (p = 0.002). There were no significant differences in recovery time among the participants in sugammadex groups. The pharmacokinetics of sugammadex were comparable to those of literature findings. Although two hypotensive events related to sugammadex were observed, no intervention was necessary. Conclusion: The findings of this pharmacokinetic analysis and efficacy study of sugammadex in Korean children indicated that sugammadex (2 mg/kg) may be safely administered for reversing moderate neuromuscular blockade. Some differences in pharmacokinetics of sugammadex were observed according to age. Clinical Trial Registration: http://clinicaltrials.gov (NCT04347486).

Project description:Background and Objectives: Sugammadex is widely used in anesthesia to reverse rocuronium-induced neuromuscular blockade (NMB). In patients with compromised kidney function, most drugs show alteration of their pharmacokinetic profile with reduced clearance. The purpose of this article is to examine the efficacy, pharmacokinetics, and safety of sugammadex in end-stage renal disease (ESRD) patients receiving general anesthesia, using a systematic review. Materials and Methods: The databases of PubMed, EMBASE, the Cochrane Library, Web of Science, Scopus, KoreaMed, and ClinicalTrials.gov were searched for studies comparing the efficacy or safety outcomes of sugammadex administration for the reversal of rocuronium-induced NMB, in ESRD patients (group R) or in those with normal renal function (group N) undergoing surgery under general anesthesia. Results: We identified nine studies with 655 patients-six prospective, case-control studies with 179 patients (89 and 90 in groups R and N) and three retrospective observational studies with 476 ESRD patients. In the six prospective studies, the times taken to reach a train-of-four ratio ≥0.9, 0.8, and 0.7 were significantly longer in group R than in group N (weighted mean difference [95% confidence interval] [min]: 1.14 [0.29 to 2.00], 0.9 [0.24 to 1.57], 0.89 [0.20 to 1.57], respectively). The total plasma clearance of sugammadex was significantly lower in group R than in group N. There was no significant difference in the incidence of NMB recurrence and prolonged time to recovery between the groups. In the three retrospective studies, the possibility of sugammadex-related adverse events appears to be insignificant. Conclusions: Sugammadex may effectively and safely reverse rocuronium-induced NMB in patients with ESRD, although the recovery to a TOF ratio of 0.9 may be prolonged compared to patients with normal renal function. Further studies are needed, considering the small number of studies included and the high heterogeneity of some of the results.

Dataset Information

Actual versus ideal body weight dosing of sugammadex in morbidly obese patients offers faster reversal of rocuronium- or vecuronium-induced deep or moderate neuromuscular block: a randomized clinical trial.

Background

Methods

Results

Conclusions

Trial registration

Publications

Actual versus ideal body weight dosing of sugammadex in morbidly obese patients offers faster reversal of rocuronium- or vecuronium-induced deep or moderate neuromuscular block: a randomized clinical trial.

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