With Sugammadex's recent approval in Europe, and final phase of approval in the US how do you think it will effect the practice of anesthesia? Has anyone here had the chance to use Sugammadex?
ANESTHETIC PHARMACOLOGY
Sugammadex: Another Milestone in Clinical Neuromuscular Pharmacology
Mohamed Naguib, MB, BCh, MSc, FFARCSI, MD
From the Department of Anesthesiology and Pain Medicine, Unit 409, Anderson Cancer Center, The University of Texas M. D., Houston, Texas.
Sugammadex is a revolutionary investigational reversal drug currently undergoing Phase III testing whose introduction into clinical practice may change the face of clinical neuromuscular pharmacology. A modified -cyclodextrin, sugammadex exerts its effect by forming very tight water-soluble complexes at a 1:1 ratio with steroidal neuromuscular blocking drugs (rocuronium > vecuronium >> pancuronium). During rocuronium-induced neuromuscular blockade, the IV administration of sugammadex creates a concentration gradient favoring the movement of rocuronium molecules from the neuromuscular junction back into the plasma, which results in a fast recovery of neuromuscular function. Sugammadex is biologically inactive, does not bind to plasma proteins, and appears to be safe and well tolerated. Additionally, it has no effect on acetylcholinesterase or any receptor system in the body. The compound's efficacy as an antagonist does not appear to rely on renal excretion of the cyclodextrin-relaxant complex. Human and animal studies have demonstrated that sugammadex can reverse very deep neuromuscular blockade induced by rocuronium without muscle weakness. Its future clinical use should decrease the incidence of postoperative muscle weakness, and thus contribute to increased patient safety. Sugammadex will also facilitate the use of rocuronium for rapid sequence induction of anesthesia by providing a faster onset-offset profile than that seen with 1.0 mg/kg succinylcholine. Furthermore, no additional anticholinesterase or anticholinergic drugs would be needed for antagonism of residual neuromuscular blockade, which would mean the end of the cardiovascular and other side effects of these compounds. The clinical use of sugammadex promises to eliminate many of the shortcomings in our current practice with regard to the antagonism of rocuronium and possibly other steroidal neuromuscular blockers.
I primarily use Cisatracurium in my practice. Sugammadex will not reverse this type of NDMR.
I think having a reversal agent like Sug. is a good idea for those times you can't use Sux or for very short cases where Sux is not acceptable The manufacturer has not set a price but I'm going to assume it will be pretty expensive and to use it to do routine reversals is not good use of health care dollars. IMHO.
If it's not priced competitively, it will be a tough sell after the "newness" wears off.
There's absolutely no reason to abandon common sense and normal dosing practices just because there's a new reversal agent to play with.
Vec and Roc are not owned by the same company, although they were originally marketed by the same company, Organon. Zemuron/Rocuronium is still on patent - vecuronium has been off patent for quite a few years now and is available from numerous sources.
If it's not priced competitively, it will be a tough sell after the "newness" wears off.
There's absolutely no reason to abandon common sense and normal dosing practices just because there's a new reversal agent to play with.
Vec and Roc are not owned by the same company, although they were originally marketed by the same company, Organon. Zemuron/Rocuronium is still on patent - vecuronium has been off patent for quite a few years now and is available from numerous sources.
Hmm...they seem to still be marketed/"pushed" by Organon and can both be found on Organon's website.
According to the Organon drug rep Zemuron is going off patent this year, and from what I found on the internet the patent expired in April 2008. http://smaranya.com/category/wyeth/
My understanding is that the company is pushing higher safety margins using Sugammedex vs. neo/glyco etc. I don't know if this actually pans out in the literature, but if there is even a small truth to it then it will just be another reason for lawyers to question someone's anesthesia practice in a malpractice case.
It will be interesting to see how it pans out in actual practice.
I have been hearing about this drug for a long time. Have talked to many European providers who have used it. It sounds like a really nice drug... But I cannot see me using much of it on a regular basis.. Questions have already arisen about the cyclodextrin molecules ability to render non active.. not only steroidal NDMBs.. BUT endogenous steroids as well as the steroidal portion of the molecules looks the same to sugammadex. That being said.. is anyone here old enough to remember the LAST BIG THING in NDMBs?? Rapalon ( rapacuronium) . Touted by the drug company spokesmodels/ bagel delivery and pen supplier people as the \"Sine qua non\" of modern anesthesia practice? RIGHT up to the point it started killing people. BTW.. did you all realize this is the same chemical technology that is found in FaBreez??
In my hands, Cis is way more predictable than Roc. I give an appropriate dose and I have a relaxed patient. With Roc, I give what is supposed to be an appropriate dose that's supposed to last..yeah long...and I find I have 4 strong twitches way before I feel I'm supposed to. Or on the other hand, with Roc, I give what I think is an appropriate dose and I don't have twitiches for the longest time???? What's up with that? Acts like 2 different drugs, in my hands. So I've given up using it unless I have to.
I also like any drug with 2 ways, not just 1 way, of metabolism. It's good for all patients ie....Renal etc...so I don't have to worry about that.
I'm not a salesperson for Cis, and I don't get paid for this...but give it a try, you'll love it.
skip
I've mainly been using roc and have a MDA that's been talking about new literature that roc should be dosed more according to age than weight. I can't find anything, have you heard of such dosing?
I've mainly been using roc and have a MDA that's been talking about new literature that roc should be dosed more according to age than weight. I can't find anything, have you heard of such dosing?
No, can't say that I have. I'll look around a bit or I'll talk to our rep. She's outstanding and will be able to address it.
I use a lot of vec. Roc, Vec all the same different name the difference is so slight as to ne negligable. I have not been doing this forever, but I do not have any problems with patient being to relaxed to reverse at end of procedure, the only reason to use suggamadex, I think.
As for Cis, I haver used but for me it is no different then roc or vec, just more expensive.
Common sense in dosing and the ability to rustle ones hands and ask with a concerned look on your face asking "better?" Can give all the relaxation a surgeon needs.
Common sense in dosing and the ability to rustle ones hands and ask with a concerned look on your face asking "better?" Can give all the relaxation a surgeon needs.
Pay attention boys and girls - that's a true statement right there!
Nimbex- this is a totally subjective opinion, but I find nimbex and vecuronium terrible to intubate with. I like vecuronium better than roc for maintenance dosing as you can almost set your watch to its elimination. I once read something about rocuroniums dose dependent elimination, and have found with additional doses after induction becomes less and less predictible...however, I feel it is far superior to vec or nimbex during intubating situations. Again, just my two cents.
Supposedly, the good news about cyclodextrin reversal agents is you can reverse people from deep NMB. I heard a guy talk once about a study in Europe with healthy volunteers...they gave some rediculous dose of Rocuronium...I want to say upwards of 1mg / kg, then reversed them before getting any twitches back with full resolution. (yeah 90mg of roc in a 90kg person).
So with all the side effects associated with Sux, and Roc being purportedly as useful during RSI will a higher ceiling for Roc due to easy reversal eliminate the need for Sux? Notice I said purportedly? I still think sux is the best intubating drug, no matter what the organon rep buys us for lunch.
Here is an interesting article r/t sugammadex...http://bja.oxfordjournals.org/cgi/content/abstract/100/3/373
Safety and tolerability of single intravenous doses of sugammadex administered simultaneously with rocuronium or vecuronium in healthy volunteers
G. Cammu1,*, P. J. De Kam2, I. Demeyer1, M. Decoopman1, P. A. M. Peeters2, J. M. W. Smeets2 and L. Foubert1
They all intubate the same at equipotent doses, just one eliminates by hoffman and one is under patent so it really gets pushed by the drug companies, maybe and just maybe vec takes 20-30 sec longer but outside of RSI who cares?
Well, I think we really need to make that distinction. When many nurses such as my self respond, in most cases we are looking at this from a RSI viewpoint. I know I have been very careful about emphasizing my experience with NMBA's is not anesthesia related.
With that, I am really not sure how much this will change true anesthesia practice. However, I suspect one concern that somebody has discussed could materialize. If we end up having an airway related adverse event, the media could run with a story about the bad anesthesia providers not using drugs that can be reversed with the new miracle drug. Then, the sheeple get ahold of it, and we have everybody but the actual anesthesia providers making policy for the practice of anesthesia.
I know this could be a big thing in EMS where lawyers stand to make big bucks on every RSI where Roc/Vec was not used and the media stands to gain great stories.
Pretty typical stuff in the era of modern medicine however.
They all intubate the same at equipotent doses, just one eliminates by hoffman and one is under patent so it really gets pushed by the drug companies, maybe and just maybe vec takes 20-30 sec longer but outside of RSI who cares?
again, this is totally subjective from my mere 4 years of experience, but nothing beats sux in both rapidity and quality when it comes to intubating relaxation.
furthermore what dose of cisatracurium would you call equipotent to 50mg of roc? I probably have a preconception in my head that nimbex is lame for intubating, even if I dose it according to insert guidelines for intubation. It may be my timing or pkinetics.
and the vec thing...yeah, I am probably just being impatient, but I will still say it is lame for intubating. Who wants a slow induction? I like getting on the highway with a v8, not a four banger (don't tell anyone I drive a 4 banger)
jwk
1,102 Posts
If it's not priced competitively, it will be a tough sell after the "newness" wears off.
There's absolutely no reason to abandon common sense and normal dosing practices just because there's a new reversal agent to play with.
Vec and Roc are not owned by the same company, although they were originally marketed by the same company, Organon. Zemuron/Rocuronium is still on patent - vecuronium has been off patent for quite a few years now and is available from numerous sources.