Sugammadex

[docB]

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Does anyone know what the status on sugammadex is? Is it officially dead per the FDA or is there a possibility it will eventually get approval?

To recap it's the drug that can reverse rocuronium. It could theoretically make sux obsolete and make it so we never again need to worry about all the contraindications to depolorizing neuromuscular blockers.

http://en.wikipedia.org/wiki/Sugammadex

 

[jbar]

I gotta stop reading thread headings when tired. At first I thought this was about an index of sugar mammas. (Sugarmamadex) (like Poisindex)

Joking aside I haven't been able to find any updates beyond saying that the FDA blocked it a few years ago, the company kept doing trials. And it looks like it was approved in Europe.

http://www.ncbi.nlm.nih.gov/pubmed/19833281

I feel like after these drugs do okay in europe for a few years and there are some studies it gets approved here.

 

[Apollyon]

They were talking about this two years ago in the anesthesia forum.

I can't think of a time when I needed to reverse NMB, so I don't know if this would ever help me. I did need neostigmine for a myasthenia gravis patient a few weeks ago, and, even in the evening, was rather quick from the pharmacy. Were I to need NMB reversal, neo or physostigmine should be readily available, based on experience (and, if it's an issue, the nurse manager can get it from the OR, as the anesthesiologists use them frequently).

 

[southerndoc]

I can't comment too much on it because of a non-disclosure agreement (consulting work for a hedge fund).

Here's what I can say:

Initially not approved by the FDA because of concerns for anaphylaxis. Approved in the EU and has been used without problems for a while now. Likely will go before FDA again in another year or so.

Can't say anything else without violating the NDI.

 

[BADMD]

Were I to need NMB reversal, neo or physostigmine should be readily available, based on experience (and, if it's an issue, the nurse manager can get it from the OR, as the anesthesiologists use them frequently).

For a case where I wanted to reverse NMB in the ED, I would not want to rely on a -stigmine. The only times I have wanted to reverse were airway disasters. I want something fast, reliable, safe, and easy to use. Sugammadex is a much more elegant and reliable way to reverse than a cholinesterase inhibitor and will likely work, even if I used less than ideal Roc dosing. I would also expect a much wider therapeutic window with Sugammadex when compared to the -stigmines and it would seem much easier to use in less experienced hands.

 

[Apollyon]

For a case where I wanted to reverse NMB in the ED, I would not want to rely on a -stigmine. The only times I have wanted to reverse were airway disasters. I want something fast, reliable, safe, and easy to use. Sugammadex is a much more elegant and reliable way to reverse than a cholinesterase inhibitor and will likely work, even if I used less than ideal Roc dosing. I would also expect a much wider therapeutic window with Sugammadex when compared to the -stigmines and it would seem much easier to use in less experienced hands.

I hear you 100%. Maybe I should have prefaced with something like "my first choice is brutane - just bag until the NMB wears off". Reversal agents always give me the willies (including flumazenil, neo/physostigmine, and naloxone/naltrexone). Perhaps that's why I tend to avoid them entirely, or, if needed, just a touch.

 

[proman]

There are uses for sugammadex in the ED, mostly to avoid succinylcholine (which is in shortage, still).

First, when sux is contraindicated, rocuronium will give you similar onset but extremely variable offset. Let's say you want to preserve your neuro exam. Sugammadex reverses deep paralysis quickly and reliably.

Second, you find yourself in a can't intubate, can't ventilate situation after giving your rocuronium. Current practice would lead to a surgical airway. With sugammadex you can reverse that paralysis and return to spontaneous breathing. Obviously it's more applicable in the anesthesiology than EM, it's still a drug that should be available wherever nondepolarizer blockers are used.