drugset / Trial / NCT00895609
Sugammadex and Neostigmine at Shallow Neuromuscular Blockade
RandomizedParallel-groupTriple-blindTreatment
Summary
This study is designed to compare recovery times after reversal of a residual neuromuscular block (TOF-ratio 0.5) with different doses of either neostigmine or sugammadex.
Timeline
- Start
- 2009-03
- Primary completion
- 2009-08
- Completion
- 2009-08
Publications
- Background Jones RK, Caldwell JE, Brull SJ, Soto RG. Reversal of profound rocuronium-induced blockade with sugammadex: a randomized comparison with neostigmine. Anesthesiology. 2008 Nov;109(5):816-24. doi: 10.1097/ALN.0b013e31818a3fee.
- Background Puhringer FK, Rex C, Sielenkamper AW, Claudius C, Larsen PB, Prins ME, Eikermann M, Khuenl-Brady KS. Reversal of profound, high-dose rocuronium-induced neuromuscular blockade by sugammadex at two different time points: an international, multicenter, randomized, dose-finding, safety assessor-blinded, phase II trial. Anesthesiology. 2008 Aug;109(2):188-97. doi: 10.1097/ALN.0b013e31817f5bc7.
- Background Flockton EA, Mastronardi P, Hunter JM, Gomar C, Mirakhur RK, Aguilera L, Giunta FG, Meistelman C, Prins ME. Reversal of rocuronium-induced neuromuscular block with sugammadex is faster than reversal of cisatracurium-induced block with neostigmine. Br J Anaesth. 2008 May;100(5):622-30. doi: 10.1093/bja/aen037. Epub 2008 Apr 2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Neostigmine | Other / unclassified | 5 mg/kg | Intravenous |
| Subject | Neostigmine | Other / unclassified | 8 mg/kg | Intravenous |
| Subject | Neostigmine | Other / unclassified | 15 mg/kg | Intravenous |
| Subject | Neostigmine | Other / unclassified | 25 mg/kg | Intravenous |
| Subject | Neostigmine | Other / unclassified | 40 mg/kg | Intravenous |
| Subject | Sugammadex | Other / unclassified | 0.0625 mg/kg | Intravenous |
| Subject | Sugammadex | Other / unclassified | 0.125 mg/kg | Intravenous |
| Subject | Sugammadex | Other / unclassified | 0.25 mg/kg | Intravenous |
| Subject | Sugammadex | Other / unclassified | 0.5 mg/kg | Intravenous |
| Subject | Sugammadex | Other / unclassified | 1 mg/kg | Intravenous |