Sugammadex!?!?!

[C.P.]

yeah. . . remember that wonder drug that we kept waiting for, then suddenly got yanked.

August 2008 the FDA rejected its approval.

July 2008, the EU approved it.
I guess Australia picked sides and went with the EU on this one.

I was doing a case yesterday, supervising a resident.
Lap appy.
The Resident, good intentions, just bad math, gave 90mg of Roc to a 50kg 25yr woman.

The appy is done in 30 minutes.

Wanna guess what the train of four is. . . .?

Zilch.

and then the lightbulb hits me. . . they have sugammadex here, and everyone else seems to use it pretty frequently.

So I go grab a vial, dose the patient, and then wait.

I put the twitch monitor on 1 second intervals and let it go to see when things came back.

Un-friggin-believeable!

literally in under 2 minutes I had sustained tetanus.

I'm not questioning the FDA. . . way too much going on with that topic to even begin. . . but this drug is really amazing.

I'm not planning on using it regularly (not yet at least), but after my N of 1 trial, I'm sold.

---

Members don't see this ad.

 

[sevoflurane]

Ahhh.... jealous.

Sounds pretty sweet.

90mg of roc reversed in a skinny winny...in minutes.... ??

I want some. 🙁

 

[epidural man]

yeah. . . remember that wonder drug that we kept waiting for, then suddenly got yanked.

August 2008 the FDA rejected its approval.

July 2008, the EU approved it.
I guess Australia picked sides and went with the EU on this one.

I was doing a case yesterday, supervising a resident.
Lap appy.
The Resident, good intentions, just bad math, gave 90mg of Roc to a 50kg 25yr woman.

The appy is done in 30 minutes.

Wanna guess what the train of four is. . . .?

Zilch.

and then the lightbulb hits me. . . they have sugammadex here, and everyone else seems to use it pretty frequently.

So I go grab a vial, dose the patient, and then wait.

I put the twitch monitor on 1 second intervals and let it go to see when things came back.

Un-friggin-believeable!

literally in under 2 minutes I had sustained tetanus.

I'm not questioning the FDA. . . way too much going on with that topic to even begin. . . but this drug is really amazing.

I'm not planning on using it regularly (not yet at least), but after my N of 1 trial, I'm sold.

Stupid FDA - the only orginization run worse than mine (NAVY) is the stupid FDA.

 

[cchoukal]

I got into a discussion about sugammadex the other day, and I started to wonder if this drug has much of a market anymore. Sure, every once in awhile a resident is going to give too much roc, or the case will go from a 9 hour whipple to a 30 minute peak-and-shreek (although, let's face it, by the time they close, you can reverse the old-fashioned way).

What is the cost/risk/benefit profile for sugammadex (expensive, potential for hypersensitivity reactions) compared to just waiting another 20 minutes in the OR with egg on your face?

My impression of the really important use for this would be in the RSI who can't have succ, gets an RSI dose of roc, and becomes a can't-intubate-can't-ventilate scenario. 5 years ago, when the drug was being developed, that indication made a lot of sense, but now that there are LMAs, glides, and fibers everywhere, does this indication still exist? Nevermind that, as far as I know, no one has every actually tested/published a paper of use of sugammadex for this indication.

 

[mustang1]

I have heard that sugammadex costs like 50 cents a mg. I am guessing you would need at least 8 mg/kg to reverse that quickly after giving so much roc (maybe even 16mg/kg). That puts the cost of dose at $200-400 for this woman. Still just a med student and have spent only a few months with anesthesia. Are these costs justified? Would love to hear the opinions of attendings etc. that are able to shed some light on the this. Thanks!

 

[mustang1]

Looks like cchoukal beat me to it on the price question. The only papers I have read regarding sugammadex for RSI contrasted using roc/sugammadex and sux. They showed that reversing with sugammadex was on average 3.5minutes faster than waiting for sux to wear off on its own. Of course in these studies an emergency was only simulated and sugammadex was already drawn up and ready (this would be wicked expensive to do for every "RSI" with roc) so need to add another minute or so, depends on how deft you are, to locate and reconstitute three vials.
Does anyone know why the FDA did not approve sugammadex? Haven't got this far in my reading 🙂

 

[Idiopathic]

Looks like cchoukal beat me to it on the price question. The only papers I have read regarding sugammadex for RSI contrasted using roc/sugammadex and sux. They showed that reversing with sugammadex was on average 3.5minutes faster than waiting for sux to wear off on its own. Of course in these studies an emergency was only simulated and sugammadex was already drawn up and ready (this would be wicked expensive to do for every "RSI" with roc) so need to add another minute or so, depends on how deft you are, to locate and reconstitute three vials.
Does anyone know why the FDA did not approve sugammadex? Haven't got this far in my reading 🙂

hypersensitivity/allergic rx in phase III subjects.

if you are talking about a situation like mine, where wasted OR time costs like $40 a minute, then yeah it might be worth it to have that drug handy. also, some people just cannot tolerate residual relaxant, and so when you absolutely positively have to be right, it may save you a trip to the deposition suite.

id love to have access to it, but i wouldnt use it routinely. one more step towards robo-anesthesia.

 

[Ronin2258]

hypersensitivity/allergic rx in phase III subjects.
...

I'd love to have access to it, but i wouldnt use it routinely. one more step towards robo-anesthesia.

Just because most of us don't use it routinely, doesn't mean others wouldn't. There are those who would use it as a "hail Mary play" drug if they got sloppy. I can see something in the ER or a code:

"Just give them 10cc of roc and get the tube in. We can always reverse it."

A lecture regarding sugammedex was given to us recently. Got the impression it would encourage sloppiness in using paralytics by people who think this is a something to save your bacon. At least from the lecturer's point of view.

Do I agree with the lecturer? I can see the point of view. I would much rather see paralytics wearing off normally than introduce another drug for reversal.

Things for me have been good so far with calculations/surgical time estimates, only had to reverse a couple of times. Attending I worked with was a fan of negative inspiratory pressures to determine paralytic wearing off.

To be quite honest, the paralytics still make me a bit skittish. Likely because of what I perceive as a lack of reliable control. I know it's better to be good with your calculations, but in the back of my mind I still know being human, we make mistakes. And while people in the emergency situation I described above may not weigh in the side effects of reversal (and unknowingly make their situation worse with the additional sugammedex allergic reactions,) we have to take it into consideration.

 

[cchoukal]

Things for me have been good so far with calculations/surgical time estimates, only had to reverse a couple of times. Attending I worked with was a fan of negative inspiratory pressures to determine paralytic wearing off.

Only had to reverse a couple of times? A lot of people, myself included, think nearly everyone should get some amount of "reversal." Find the article in A/A from 2008 on residual neuromuscular blockade in the PACU. It's much more common than we think.

 

[Idiopathic]

reverse everyone.

 

[Mman]

reverse everyone.

agreed.


What's the downside? Some GI side effects from the neostigmine? Small potatoes compared to the potential risk (however small) of residual neuromuscular block.

 

[pgg]

What's the downside? Some GI side effects from the neostigmine? Small potatoes compared to the potential risk (however small) of residual neuromuscular block.

I reverse everyone too.

If sugammadex was available, cheap, and safe I'd use it every time. Why would anyone prefer the inelegant neostigmine mechanism, with another drug needed to counter its undesired muscarinic side effects, if there's a direct antagonist available?


But it's not available or cheap, and the FDA seems to think it's unsafe, so moot point, for now.

 

[proman]

Ditto about reversal. Who mixes the glyco/neo together? I don't, and see no benefit from it.

 

[Arch Guillotti]

joining the reversal bandwagon

 

[Lightwand]

I always reverse. I do mix my neo/glyco, except for in peds cases.

 

[jwk]

I have heard that sugammadex costs like 50 cents a mg. I am guessing you would need at least 8 mg/kg to reverse that quickly after giving so much roc (maybe even 16mg/kg). That puts the cost of dose at $200-400 for this woman. Still just a med student and have spent only a few months with anesthesia. Are these costs justified? Would love to hear the opinions of attendings etc. that are able to shed some light on the this. Thanks!

Price in the US market will probably end up being the determining factor as to whether or not people use it routinely (if it ever becomes available at all). Those expensive OR times are not exaggerated - $40-50 per minute are very common, and of course if it's in 15 minute increments, trip over that extra minute cutoff and you've just added another $600-750 to the bill.

One of the reasons there was a lot of excitement about the drug was there was now an alternative for sux. Give a whopping dose of roc, intubate in about the same time as sux, and then reverse it a few minutes later. Great for those 10 minute lap appys.

I don't automatically reverse everyone like I used to - I still reverse most patients, but I'm trying to back off my dose a little. I think routinely NOT reversing is asking for nothing but trouble. Unless you routinely use some sort of acceleromyography, "measuring" TOF is one of the least reliable and most subjective clinical monitors we have. I've NEVER been sorry I reversed a patient, and have never reintubated a patient in the PACU due to residual NMB.

 

[Ketafol20]

I just finished a 5 hr B mastectomy with breast reconstruction. The pt got 30 mg Roc for intubation and no more. Who wants to reverse this pt? Why?

BTW the cost of Sugamedex is a non issue when you compare it to OR time and potential complications of residual muscle relaxation.

 

[sevoflurane]

I just finished a 5 hr B mastectomy with breast reconstruction. The pt got 30 mg Roc for intubation and no more. Who wants to reverse this pt? Why?

BTW the cost of Sugamedex is a non issue when you compare it to OR time and potential complications of residual muscle relaxation.

Hahaha...! I knew this was coming.

30mg of Roc for extubation 5 hrs. later? Well, I need more data, but I would betcha she is pulling 8-15ml/kg TV's, has a serious hand grip and looks like this: 😱 essentially mouthing to you to extubate her.

I likely would not reverse this patient.

 

[Ketafol20]

Hahaha...! I knew this was coming.

30mg of Roc for extubation 5 hrs. later? Well, I need more data, but I would betcha she is pulling 8-15ml/kg TV's, has a serious hand grip and looks like this: 😱 essentially mouthing to you to extubate her.

I likely would not reverse this patient.

What data do you need? It's been 5 hrs since any muscle relaxant was given. Are you gonna check TOF?

Ok I'll play. Pt has been breathing on PSV for the past 2 hrs.

 

[sevoflurane]

Take her off PSV. What is she doing on her own or on 5 and 5?

Either way... highly unlikely she is going to be week 5 hours after 30mg dose of Roc.

Mamo's are associated with n/v... I won't add to that unecesarily. I've never seen anyone weak 5 hours after a 30mg dose of Roc. How much is .5 mg/kg supposed to last? 45 minutes? We are talking about 5 hours here. That is a lot of 1/2 lives. 🙄

 

[WholeLottaGame7]

I just finished a 5 hr B mastectomy with breast reconstruction. The pt got 30 mg Roc for intubation and no more. Who wants to reverse this pt? Why?

Not me, given the clinical indicators check out. Seems silly to make a blanket statement "you should reverse everybody." Although, I would agree that you should have to come up with a reason to NOT reverse (as in the scenario above) versus coming up with a reason TO reverse.

Also, got to see sugammadex given ~50 times as a premed clinical research coordinator during one of the phase III trials. Always gave it at return of 2nd twitch as part of the study design, so didn't witness the deep reversal, but it worked like a charm and no adverse events that I was aware of.

I do think it would be nice to have (particularly as a CA-1 who knows I will end up redosing someone too late at least once despite my best efforts), even if it's not used as widespread as originally conceived. There is the issue of cost, but besides the OR time costs in private practice mentioned, I would think it would be worth stocking just to avoid the rare CI-CV catastrophes. That's a couple mil right there.

 

[Ketafol20]

I agree with you Sevo. And my example was a bit extreme but I am not of the " must reverse everyone society". I am very familiar with the studies and I take exception to someone out there writing or stating crap like that. We are professionals, not para-professionals, and we should know what is best for our pts. If I think my pt will benefit from not reversing him or her then I don't need someone in some Ivory tower telling me I must do it. That's crap. There are SE's to everything we do or give. We are aware of the SE's and we are I n the best position to decide if we want to risk them or not. It goes back to risks vs benefits. So if I don't reverse someone then I "pay attention" to the pt to see if they are meeting the criteria for extubation. If they are tenuous then I reverse them or I watch them more closely in pacu until they are safe.

I'm not talking only to you Sevo, I know you understand this. 🙂

 

[dhb]

I agree with K20 i don't reverse everyone but i have a still have a low threshold for reversal.
I don't use a lot of muscle relaxant (don't do a lot of abdominal surgery) and when i do i'll use low doses eg. 0.3mg of roc which generally lasts for 30min (comparable to mivacron) for surgeries that last more than an hour. If i redose i generally reverse.
If in doubt though i'll always reverse.

 

[C.P.]

Ditto about reversal. Who mixes the glyco/neo together? I don't, and see no benefit from it.

I usually don't mix them, but just out of habit since I do a fair share of kiddos.
It may be just where I trained, but I'd get shot if I tried to reverse a two year old and didn't give the glyco first and then chase a bit later with the Neo, to prevent a vagal crash.

 

[C.P.]

Looks like cchoukal beat me to it on the price question. The only papers I have read regarding sugammadex for RSI contrasted using roc/sugammadex and sux. They showed that reversing with sugammadex was on average 3.5minutes faster than waiting for sux to wear off on its own. Of course in these studies an emergency was only simulated and sugammadex was already drawn up and ready (this would be wicked expensive to do for every "RSI" with roc) so need to add another minute or so, depends on how deft you are, to locate and reconstitute three vials.
Does anyone know why the FDA did not approve sugammadex? Haven't got this far in my reading 🙂

yeah, Idiopathic hit it dead on. They held it up because of allergic/hypersensitivity issues. Although, to be fair, I don't know what the numbers/severity of it was, so I can't comment.

I do wonder though, if there were some commercial interests in not having it released. Anyone wonder why it's taken over a decade to get IV acetaminophen released, but we just got the patented IV ibuprofen on the market now? Wanna bet IV acetaminophen won't hit till this one's no longer a cash cow?

Likewise, I wonder if something else might be in the pipe against sugammadex?

 

[C.P.]

A lecture regarding sugammedex was given to us recently. Got the impression it would encourage sloppiness in using paralytics by people who think this is a something to save your bacon. At least from the lecturer's point of view.

Do I agree with the lecturer? I can see the point of view. I would much rather see paralytics wearing off normally than introduce another drug for reversal.

I can see part of that argument, but for me, if sugammadex plays out safety wise, then I'd much rather use high dose roc with sugammadex reversal than sux.
We can debate the myalgias, potassium bump, etc, but a really important fact that many people either never get taught or often forget:
SUX doesn't wear off fast in everybody.
In fact, about 1:30 people are atypical acetylators. I'm not talking dibucaine numbers in the 20s, but atypical enough to make that "it'll wear off in 5 minutes" safety blanket we all hold onto more like a kleenex.

The advantage for something like sugammadex is the more definitive aspect of it's reversal.

To be fair though, the package insert does mention you have to watch out for small numbers that may reparalyze after sugammadex.
Unfortunately, it didn't say why.

FYI: I used 4 mg/kg when I dosed this patient.

 

[Endee]

At the major children's hospital I'm rotating through right now, they mix glyco and neostigmine for all reversals. When I tried to give them separately one of my attendings said "we just mix them here."

I was surprised, but did what they wanted. Haven't had any kids go bradycardic.

I usually don't mix them, but just out of habit since I do a fair share of kiddos.
It may be just where I trained, but I'd get shot if I tried to reverse a two year old and didn't give the glyco first and then chase a bit later with the Neo, to prevent a vagal crash.

 

[BobBarker]

I just redose my roc 20mg at a time, hard to burn yourself too bad that way.

 

[Idiopathic]

I just redose my roc 20mg at a time, hard to burn yourself too bad that way.

seriously? i induce with 0.5mg/kg and redose with no more than 0.1mg/kg, or 5-10 mg. I absolutely think you can get burned with 20mg roc.

edit: to reinforce, i supervise very junior providers, and people that like to do things like give "whatever's left in the syringe". im sure you do the right thing for your patients.

 

[BobBarker]

Usually with 20mg, I lose all twitches for only about 5 minutes. Some of the attendings say our roc is weak. Had a lady the other day that had 4 twitches within 20 minutes of a 50mg induction dose.

 

[WholeLottaGame7]

Usually with 20mg, I lose all twitches for only about 5 minutes. Some of the attendings say our roc is weak. Had a lady the other day that had 4 twitches within 20 minutes of a 50mg induction dose.

That does sound a little strange. Probably ~90% of the stories I hear of people being burned is with Roc. As a previous poster said, I usually redose 10mg at a time, particularly in smaller patients (unless I know we're in the middle of a long case, etc). I'd much rather redose every 15min than get burned, plus, it makes sure I'm constantly thinking about whether or not this patient needs paralysis.

 

[cfdavid]

Only had to reverse a couple of times? A lot of people, myself included, think nearly everyone should get some amount of "reversal." Find the article in A/A from 2008 on residual neuromuscular blockade in the PACU. It's much more common than we think.

I was thinking the same. I always give at least some reversal, which is supported by every attending I've worked with thus far.

 

[cfdavid]

That does sound a little strange. Probably ~90% of the stories I hear of people being burned is with Roc. As a previous poster said, I usually redose 10mg at a time, particularly in smaller patients (unless I know we're in the middle of a long case, etc). I'd much rather redose every 15min than get burned, plus, it makes sure I'm constantly thinking about whether or not this patient needs paralysis.

Same here. I've noticed some of our CRNA friends, however, very heavy handed with the paralytic regardless of whether it's even necessary to redose. The thinking about whether or not the patient needs paralysis part, is ummm, kind of important.

 

[Ronin2258]

I was thinking the same. I always give at least some reversal, which is supported by every attending I've worked with thus far.

I have only worked with 3 attendings so far. The one who doesn't regularly reverse after 30+ years in the biz is the one I have done most of my cases. This is the same person that does inhalational inductions (30 of the 57 cases (all adult,) I have done so far.)

I am gradually getting with attendings who do reverse regularly. One other classmate did get burned with another attending where the reversal wore off/failed, requiring re-intubation in the PACU.

Back to sugammedex:

Are there trials published about it's reactions?

 

[RussianJoo]

I am a brand new CA-1 and I've never had a problem with having no twitches at the end of the case. Maybe it's because I use sux so much but my typical induction is 2mg of Versed on the way to the OR, 1.5mg/kg to 2mg/kg of propofol, 150 to 250mcg of fentanyl, 100mg of Sux, then I check for 4 TOF and reparalyze with a few mg of vecuronium, anywhere from 3 to 7.

I usually don't really redose if I give 7 at the beginning of the case, I used to get my pt's breathing with Tv of ~200 when the surgeons closed fascia and would titrate fentanyl 25mcg's at a time to a RR of 14 to 18, and start turning down the iso. It takes surgeons around here ~20min to close. I reverse with Neo/Glyco 5/1mg once the curtains go down, by the time the pt is cleaned up and the stretchers is in the room they're pulling higher Tv's, I move them to the stretcher and that usually wakes them up and allows me to extubate.

Lately I've been trying to keep the pt's paralyzed with 1 to 2 twitches and on the vent allowing me to blow off more iso faster, right until the curtains come down and then reverse them and keep titrating down the iso and allow the CO2 to build up. But still I only dose 1 to 2mg of vec at a time.


I guess I just haven't had the need for the pt to be completely paralyzed until the end of the case, but i keep my pt's fairly deep so they don't move till the end of the case. I also have a 10cc syringe of propofol in case they get light.

 

[jwk]

I just redose my roc 20mg at a time, hard to burn yourself too bad that way.

Oh you'll get burned - it just hasn't happened yet. Of course it's much harder to get burned during a 45 minute med-student skin closure.

 

[dhb]

I just redose my roc 20mg at a time, hard to burn yourself too bad that way.

Wow your roc is weak! 10mg is enough to get burned, i redose 5 to 10 max

 

[Arch Guillotti]

I just redose my roc 20mg at a time, hard to burn yourself too bad that way.

You have some very weak roc, because I think that it a large amount to be redosing.

 

[RussianJoo]

who makes the strongest Roc??? Bob who makes the roc that you use? I presonally don't use Roc very often, too expensive for my current hospital. Vec isn't too bad to use. My next hospital I'll rotate in has a better payer mix so that's where I'll use Roc and mostly Sevo, maybe some Des. It will be an interesting change. So sick of doing Gyn cases.

 

[Ronin2258]

...So sick of doing Gyn cases.

Tell me about it. Gyn-Onc here gave me a patient for Monday with a BMI of 70+ FMS.

 

[BobBarker]

Pretty sure our pharmacy gets big vials then fills up and labels 10cc syringes for us. They probably cut it with D5. Not sure who makes ours. We can use whatever volatile we want and never use vec. Funny how different some places our.

 

[MTGas2B]

When I was a resident our hospital switched from brand rocuronium (made by Organon) to one of the first generics. I thought I noticed a significant decrease in decrease in potency with the generic roc.

Not a huge roc fan anyway.

 

[Substance]

I keep reading the drug as Suga mamma dex.

 

[epidural man]

Tell me about it. Gyn-Onc here gave me a patient for Monday with a BMI of 70+ FMS.

Seriously?

Holy crap. Please take a picture.

 

[btbam]

who makes the strongest Roc??? Bob who makes the roc that you use? I presonally don't use Roc very often, too expensive for my current hospital. Vec isn't too bad to use. My next hospital I'll rotate in has a better payer mix so that's where I'll use Roc and mostly Sevo, maybe some Des. It will be an interesting change. So sick of doing Gyn cases.

How much does Roc cost per 100mg vial? I am working at the cheapest/poorest hospital in the city (don't even have Des vaporizers) and Roc is pretty much the only non-depolarizer we use.

 

[Ronin2258]

Seriously?

Holy crap. Please take a picture.

Looked like Violet from the 1971 Willy Wonka and the Chocolate Factory. Minus the blue skin.

70 y.o. woman, glass of Jack every night, 5ft 1in, 374lbs with OA, HTN, DLD and MO for problems. For a vulvectomy. Pleasant enough, got a great 360 out of her. Did a FOB exam in holding with the boss and found out she was an easy intubation. It had the potential to be really nasty. Still took some effort to get her positioned.

Still don't know how she lived that long with that much weight on the frame.

 

[pgg]

Looked like Violet from the 1971 Willy Wonka and the Chocolate Factory. Minus the blue skin.

70 y.o. woman, glass of Jack every night, 5ft 1in, 374lbs with OA, HTN, DLD and MO for problems. For a vulvectomy. Pleasant enough, got a great 360 out of her. Did a FOB exam in holding with the boss and found out she was an easy intubation. It had the potential to be really nasty. Still took some effort to get her positioned.

Still don't know how she lived that long with that much weight on the frame.

It's interesting to me that the public perception seems to be that smoking is the absolute worst thing you can do to your body, short of hard drugs.

Of course we take care of old smokers every single day. Old really fat people are rare. I don't think that's because the morbidly obese miraculously lose weight in their old age.

Every so often the media seizes on this concept of healthy obese and I can't help but 🙄

 

[Apollyon]

Every so often the media seizes on this concept of healthy obese and I can't help but 🙄

That's a fair point, but that is talking white and black America, where people say "it's my genes! It's my glands!" while 2 fisting burgers and a giant regular Coke. However, here in Hawai'i, it's the opposite: people that are big, but have normal glucose, blood pressure, and lipids, no cardiac disease, and no diabetes (like one patient over 600lbs - I Am Not Making This Up) - but they say "It's because I eat too much" - when, if ANYONE could make a claim for it being genetic and not environmental, it's Pacific Islanders.

 

[drccw]

70 y.o. woman, glass of Jack every night, 5ft 1in, 374lbs with OA, HTN, DLD and MO for problems. For a vulvectomy. Pleasant enough, got a great 360 out of her. Did a FOB exam in holding with the boss and found out she was an easy intubation. It had the potential to be really nasty. Still took some effort to get her positioned.

Just curious, what on a FOB exam in holding tells you she's going to be an easy intubation?

How much does Roc cost per 100mg vial? I am working at the cheapest/poorest hospital in the city (don't even have Des vaporizers) and Roc is pretty much the only non-depolarizer we use.

It's cheap, I'm not sure how cheap but pretty darned cheap now that there are generics. It's cheaper for our hospital to stock than Vec. We only have Roc in our drawers. Cis comes from pharmacy but we use very very little of it (I've used it once in 3 years). I forget the exact price...

Sugammadex is awesome. I worked at one of the clinical 3 sites. sure, I understand that there were some allergic reactions but I really feel it'll come to market... If they price it right, then they will move some serious volume...

drccw

 

[dhb]

If they price it right, then they will move some serious volume...

drccw

Well they're not pricing it right in Europe. +-80€ for 200mg