Finally, an alternative to Succinylcholine in USA (short duration paralytic)
In December, 2015, FDA approved Bridion (sugammadex) injection to reverse the effects of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide. Now finally we have an alternative to succinylcholine (Mainly used for its very short duration of action).(1)
“Bridion provides a new treatment option that may help patients recover sooner from medications used for intubation or ventilation during surgery,” said Sharon Hertz, M.D., director of the Division of Anesthesia, Analgesia and Addiction Products in the FDA’s Center for Drug Evaluation and Research. “This drug enables medical personnel to reverse the effects of neuromuscular blocking drugs and restore spontaneous breathing after surgery.”
When muscle relaxant with rapid onset and short duration of action is required, we only had one choice, succinylcholine. Deadly potential problems with succinylcholine include malignant hyperthermia in susceptible individuals, increase in plasma potassium concentration. Other contraindications include anaphylaxis, increase in IOP, ICP and increased gastric pressure.
Sugammadex can also be used as an acute therapeutic option in the event of an allergic reaction against rocuronium.(2)
Sugammadex was developed in 2007, approved in European union in 2008. (3) Sugammadex is a modified γ-cyclodextrin, where cyclodextrin was modified from its natural state by placing eight carboxyl thio ether group extensions. These extensions extend the cavity size allowing greater encapsulation of the rocuronium molecule(a modified steroid).
It does not have cholinergic effects.
Most common side effects are vomiting, hypotension, pain, headache and nausea. Serious side effects include anaphylaxis (noted in 1 of 299 phase 3 trial patients in US) and bradycardia( can be reversed with Atropine).(5)
Doses are 2 mg/kg for shallow blockage, and 4 mg/kg for deep blockade. For immediate reversal three minutes after administration of maximum 1.2 mg/kg rocuronium there is a dosage of 16 mg/kg.
- https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm477512.htm
- Anaphylaxis and anesthesia: controversies and new insights. Dewachter P, Mouton-Faivre C, Emala CW Anesthesiology. 2009 Nov; 111(5):1141-50.
- BRIDION(R) (sugammadex) Injection – First and Only Selective Relaxant Binding Agent – Approved in European Union” (Press release). Schering-Plough. 2008-07-29
- Naguib M (2007). “Sugammadex: another milestone in clinical neuromuscular pharmacology.”. Anesth Analg 104(3): 575–81
- Pühringer FK, Rex C, Sielenkämper AW, et al. (August 2008). “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 109 (2): 188–97. doi:10.1097/ALN.0b013e31817f5bc7