Efficacy and Safety of Sugammadex Dosed According to Actual Body Weight (ABW) or Ideal Body Weight (IBW) in Reversal of Neuromuscular Blockade (NMB) in Morbidly Obese Participants (MK-8616-146)
Summary
The purpose of this trial is to evaluate the safety and efficacy of Sugammadex when administered according to actual body weight (ABW) as compared to ideal body weight (IBW) for the reversal of both moderate and deep neuromuscular blockade (NMB) induced by either Rocuronium or Vecuronium in morbidly obese participants. The primary hypothesis of this investigation is that, compared to obese participants dosed based on IBW, obese participants receiving Sugammadex according to ABW will demonstrate a faster time to recovery to a Train Of Four (TOF) ratio of ≥0.9 (i.e. faster NMB reversal), pooled across NMB depth and type of neuromuscular blocking agent (NMBA; Rocuronium or Vecuronium) administered.
Timeline
- Start
- 2018-01-01
- Primary completion
- 2019-01-29
- Completion
- 2019-01-29
Outcome
Mixed primary results
registry analysis (superiority test); Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW) vs Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW); p <0.0001; Hazard Ratio (HR) 2.13 (95% CI 1.50 to 3.01); Log Rank NCT03346070 ↗
paper 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. PMID 33639839 ↗
registry analysis (superiority test); Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW) vs Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW); p = 0.709; Difference in percentage 1.3 (95% CI -6.8 to 9.6); Miettinen & Nurminen method NCT03346070 ↗
Publications
- Background Mostoller K, Wrishko R, Maganti L, Herring WJ, van Zutphen-van Geffen M. Pharmacokinetics of Sugammadex Dosed by Actual and Ideal Body Weight in Patients With Morbid Obesity Undergoing Surgery. Clin Transl Sci. 2021 Mar;14(2):737-744. doi: 10.1111/cts.12941. Epub 2020 Dec 16.
- Horrow JC, Li W, Blobner M, Lombard J, Speek M, DeAngelis M, Herring WJ. 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. BMC Anesthesiol. 2021 Feb 27;21(1):62. doi: 10.1186/s12871-021-01278-w.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Glycopyrrolate | Small molecule | 10 ug/kg | Intravenous |
| Comparator | Neostigmine | Other / unclassified | 50 ug/kg | Intravenous |
| Subject | Sugammadex | Other / unclassified | 2 mg/kg | Intravenous |
| Subject | Sugammadex | Other / unclassified | 4 mg/kg | Intravenous |
| Background | Rocuronium | Other / unclassified | — | Intravenous |
| Background | Vecuronium | Small molecule | — | Intravenous |
Indications
No indication recorded.