drugset / Trial / NCT03579589
The Effect of Sugammadex Versus Neostigmine During Neuromuscular Blockade Reversal
RandomizedParallel-groupOpen-labelTreatment
Summary
Patients who undergo surgery receive drugs called neuromuscular blocking agents (NMBA) that to block the activity of muscles. When the surgery is over, the block needs to be reversed. Suggammadex and neostigmine are examples of drugs that reverse blocks. This study aims to investigate if sugammadex is associated with a significantly reduced time to discharge from the operating room to the postoperative unit when compared to neostigmine.
Timeline
- Start
- 2018-08-15
- Primary completion
- 2019-12-15
- Completion
- 2019-12-15
Publications
- Background Sokol-Kobielska E. Sugammadex - indications and clinical use. Anaesthesiol Intensive Ther. 2013 Apr-Jun;45(2):106-10. doi: 10.5603/AIT.2013.0023.
- Background Ali HH, Utting JE, Gray C. Stimulus frequency in the detection of neuromuscular block in humans. Br J Anaesth. 1970 Nov;42(11):967-78. doi: 10.1093/bja/42.11.967. No abstract available.
- Background Sundman E, Witt H, Olsson R, Ekberg O, Kuylenstierna R, Eriksson LI. The incidence and mechanisms of pharyngeal and upper esophageal dysfunction in partially paralyzed humans: pharyngeal videoradiography and simultaneous manometry after atracurium. Anesthesiology. 2000 Apr;92(4):977-84. doi: 10.1097/00000542-200004000-00014.
- Background Keating GM. Sugammadex: A Review of Neuromuscular Blockade Reversal. Drugs. 2016 Jul;76(10):1041-52. doi: 10.1007/s40265-016-0604-1.
- Background Nag K, Singh DR, Shetti AN, Kumar H, Sivashanmugam T, Parthasarathy S. Sugammadex: A revolutionary drug in neuromuscular pharmacology. Anesth Essays Res. 2013 Sep-Dec;7(3):302-6. doi: 10.4103/0259-1162.123211.
- Background Co, M. Bridion® (sugammadex) injection, for intravenous use: US prescribing information. 2015. 2015 [cited 2016 10 OCT ]; http://www.accessdata.fda.gov/. ].
- Background Grintescu, I., et al., Comparison of the cost-effectiveness of sugammadex and neostigmine during general anaesthesia for laparoscopic cholecystectomy. BJA: The British Journal of Anaesthesia, 2009. 103(6).
- Background Carron M, Zarantonello F, Tellaroli P, Ori C. Efficacy and safety of sugammadex compared to neostigmine for reversal of neuromuscular blockade: a meta-analysis of randomized controlled trials. J Clin Anesth. 2016 Dec;35:1-12. doi: 10.1016/j.jclinane.2016.06.018. Epub 2016 Aug 4.
- Background Paton F, Paulden M, Chambers D, Heirs M, Duffy S, Hunter JM, Sculpher M, Woolacott N. Sugammadex compared with neostigmine/glycopyrrolate for routine reversal of neuromuscular block: a systematic review and economic evaluation. Br J Anaesth. 2010 Nov;105(5):558-67. doi: 10.1093/bja/aeq269. Epub 2010 Oct 8.
- Background Donati F. Residual paralysis: a real problem or did we invent a new disease? Can J Anaesth. 2013 Jul;60(7):714-29. doi: 10.1007/s12630-013-9932-8. Epub 2013 Apr 27.
- Background Hunter JM. Reversal of residual neuromuscular block: complications associated with perioperative management of muscle relaxation. Br J Anaesth. 2017 Dec 1;119(suppl_1):i53-i62. doi: 10.1093/bja/aex318.
- Fiorda Diaz J, Echeverria-Villalobos M, Esparza Gutierrez A, Dada O, Stoicea N, Ackermann W, Abdel-Rasoul M, Heard J, Uribe A, Bergese SD. Sugammadex versus neostigmine for neuromuscular blockade reversal in outpatient surgeries: A randomized controlled trial to evaluate efficacy and associated healthcare cost in an academic center. Front Med (Lausanne). 2022 Dec 8;9:1072711. doi: 10.3389/fmed.2022.1072711. eCollection 2022.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Neostigmine | Other / unclassified | 50 ug/kg | — |
| Comparator | Sugammadex | Other / unclassified | 2 mg/kg | — |
| Comparator | Sugammadex | Other / unclassified | 4 mg/kg | — |
| Comparator | Sugammadex | Other / unclassified | 16 mg/kg | — |
Indications
No indication recorded.