Esophagoscopy without Sedation [VIDEO]

Here is a video demonstrating how esophagoscopy can be performed in the office without any sedation. The esophagus is the tube that connects the mouth to the stomach. The exam, called trans-nasal esophagoscopy (TNE), can be performed in any patient as long as the nose is large enough to accommodate the endoscope and lack a severe gag reflex. A very thin disposable sheath (like a condom) is used to protect endoscope and maintain sterility between patient use.

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Risk of Death From... Is...

Image courtesy of noomh / FreeDigitalPhotos.net

When it comes to risk of death from surgical procedures, it is illustrative to compare it to more common experiences.

Patients often become unduly concerned with certain risks including death without any true understanding of how rare the risk may be. Unfortunately, such rare risks may be THE reason why a patient may refuse a needed procedure in the erroneous belief that something rare has an unacceptably high chance of occurring to them.

In such situations, it may be beneficial to compare the chance of a rare risk with more common scenarios that a patient may be more familiar with.

The risk of death is... (In bold are surgical procedures)

Death from major surgery if performed within 30 days after a heart attack	1 in 7
Death from high risk open-heart surgery	1 in 20
Dying on the road over 50 years of driving	1 in 85
Dying from any cause in the next year	1 in 100
Annual risk of death from smoking 10 cigarettes per day	1 in 200
Death from UPPP surgery	1 in 500
ER treatment in the next year after being injured by a can, bottle, or jar	1 in 1,000
ER treatment in the next year after being injured by a bed mattress or pillow	1 in 2,000
Death by an accident at home	1 in 7,100
Death from tonsillectomy	1 in 10,000 - 35,000
Death by an accident at work	1 in 40,000
Death playing soccer	1 in 50,000
Death by murder	1 in 100,000
Being hit in your home by a crashing aeroplane	1 in 250,000
Death by rail accident	1 in 500,000
Being struck by lightning	1 in 10,000,000
Death from a nuclear power accident	1 in 10,000,000

References:

Surgery and the D-Word: Approaching the Topic of Death and Dying with Surgical Patients. J Palliative Care Med 2:108. doi:10.4172/2165-7386.1000108

Risk perception and communication: recent developments and implications for anaesthesia. Anaesthesia 2001;56:745-55.

Risk language and dialects. BMJ 1997;315:939-42.

Safety of Adult Tonsillectomy: A Population-Level Analysis of 5968 Patients. JAMA Otolaryngol Head Neck Surg. 2014 Jan 30. doi: 10.1001/jamaoto.2013.6215.

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Ear Tube Placement in Kids WITHOUT Sedation (Starting at 12 Months of Age)

A recent report describes how using a relatively old technology, ear tube placement can now be performed in children starting at 12 months of age with chronic ear infections or hearing loss due to fluid buildup without the need for sedation of any kind nor aggressive restraints (ie papoose). Historically, ear tube placement in the office without sedation is typically performed starting at around 12 years of age using standard local anesthesia techniques. Any younger, a child could not be trusted to stay still during the procedure due to presence of some discomfort.

In any case, a Texan ear group reports how they accomplished this simple procedure at such young ages.

First, the ear canal is cleaned as much as possible of all earwax and debris. The ear canal is than filled with an anesthetic liquid (concoction of lidocaine, epinephrine, and sodium bicarbonate). Over 10 minutes, iontophoresis was than used to induce profound local anesthesia to the ear canal and eardrum. The liquid was than suctioned out and ear tube placement was performed with a reported 90% success rate (78 of 86 ears; 17 subjects were 3 years old or younger; 8 were 12 months old).

The key to success required 3 "new" elements.

• Iontophoresis device made by Acclarent. There are other iontophoresis devices in the market (Medtronic and Otomed), but none adapted for simultaneous bilateral ear canal usage that works within 10 minutes. Iontophoresis works by applying a gentle electric current in order to actively move charged drug molecules into the skin. In this particular case, positively charged lidocaine and epinephrine.
• Optimal anesthetic solution for iontophoresis. Dubbed "EMGIM", it contains 1:12,000 epinephrine with 3.3% lidocaine hydrochloride and 0.7% sodium bicarbonate. The solution is prepared fresh prior to use by combining 10 mL of 4% lidocaine hydrochloride with 1 mL of 1:1,000 epinephrine. After mixing the lidocaine and epinephrine, 1 mL of 8.4% sodium bicarbonate is added.
• Ear tube delivery device and placement system. Typically, a competent ENT can place an ear tube in about 10-20 seconds. However, when dealing with kids who may potentially move unexpectedly and operating within a very small ear canal space, a faster and more reliable way of placing a tube was required. Hence, this new device. [link]

Of course, during the actual procedure, age-appropriate distraction was needed to minimize movement, especially given aggressive restraint was not used.

Sounds great as sedation is something to be avoided if at all possible. However, there is one problem... the Acclarent iontophoresis device is NOT yet FDA approved contrary to what the report states (direct communication with Acclarent executives October 1, 2013). Hopefully in 2014. As such, beyond a research setting, this in-office technique is not yet available for use in the United States.

As an aside, there are FDA-approved iontophoresis devices for use in pediatric head and neck surgical procedures mainly for sub-cutaneous mass excisions and abscess incision and drainage. Check out Phoresor for such applications using lidocaine infused electrodes. It's even sold on Amazon.


References:
Otologic Iontophoresis: A No-Papoose Technique. Annals of Otology. Rhinology & Laryngology 122(8):487-491. Aug 2013.

In-Office Tympanostomy Tube Placement Under Local Anesthesia Using a Novel Tube Delivery Device. Triological Meeting Poster. Dec 2012.

Iontophoresis: a needle-free, electrical system of local anesthesia delivery for pediatric surgical office procedures. J Pediatr Surg. 1999 Jun;34(6):946-9.

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Problem with Medical Protocols (and Lawsuits Because of Them)

Over the past decade working in hospitals, I've seen the proliferation of "established procedures and protocols" for literally everything under the sun...

• Chest Pain Protocol
• Discharge Protocol
• Pneumonia Protocol
• Stroke Protocol
etc, etc, etc

Protocols are essentially standing orders that are supposed to be implemented whenever a given medical situation occurs. It is supposed to follow best evidence-based practices and make it easy for healthcare personnel know what to do without thinking to hard (akin to a checklist a pilot performs before flying to ensure they did not forget something).

The problem with protocols are that it can be made so detailed as to become worthlessly bloated. To use an analogy, take the protocol, "Going Shopping Protocol."

Protocol A (Simple):
1) Make grocery list
2) Drive to supermarket
3) Pickup and purchase items on grocery list
4) Come back home

Protocol B (Detailed):
1) Pickup #2 pencil
2) Sharpen pencil to appropriate point using pencil sharpener model 15-231
3) Test pencil to ensure proper writing ability
4) Obtain 3x4 inch index card
5) Write shopping item #1 on index card using pencil (from steps #1-3)
etc, etc, etc

Now when dealing with something as complex as medicine, protocols can be a godsend or hopeless depending on how it is written and who uses it.

And, that's where protocols become problematic.

Make a protocol too detailed, and it becomes bloated to the point of being useless, especially when dealing with time-sensitive medical problems.

Take for example something as simple as "Chest Pain Protocol." Orders for EKG, aspirin, IV fluids, sublingual nitroglycerin, and morphine seem obvious (assumption being heart attack), but what if we are dealing with a 10 years old child who got punched in the stomach by a bully? What about a stabbing into the chest?

Does that mean there needs to be multiple branch-points explicitly addressed in the protocol to handle every single possible scenario of chest pain under the sun at any age for every possible scenario?

Clearly, the answer is "NO"!

So protocols are made with several assumptions:

1)  A general level of medical competence of healthcare professionals
2 ) Healthcare professionals are already familiar with a given protocol and knows when to appropriately activate it
3) Protocols are deliberately made to be not too specific as it is understood that there is variability in the care of patients. Protocols can not and should not be applied cookie cutter to every patient as there are nuances that the protocol leaves to the judgement of the doctor.

Unfortunately, by making protocols to generalized, it does open up the possibility of lawsuits.

Take an ongoing case in Georgia where the medical director of an emergency room is being sued for professional negligence in the death of a woman from a heart attack... because of a chest pain protocol he wrote. Note that this medical director NEVER provided any direct medical care, did not have an established patient-physician relationship, and was not even in the hospital when the woman came into the ER. [link]

So is the solution to avoid having any protocols in place to avoid lawsuits? Sorry... NOT having a protocol in place can also be subject to a lawsuit. In 2000, a hospital was sued for either failing to follow established anesthesia procedures or protocols or failing to have any established procedures or protocols in place. [link]

So what to do?

Well, getting sued is a risk that is inherent to the medical field, especially whenever there is a bad outcome.

As such, the default action taken by physicians and hospital administrators are to minimize or spread the risk. How?

• Have as many different physicians write-up a given protocol that is signed off by everybody (spreading the risk)
• Avoid positions of responsibility (default scapegoat for lawsuits)
• Involve many physicians in the care of a patient (spreading or transferring the risk)
• Have protocols, but do not depend on them (clinical judgement trumps protocol).
• Have MANY documented training sessions on how protocols are to be used and discuss weaknesses and strengths of them

References:
UPSON COUNTY HOSP., INC. v. HEAD 540 S.E.2d 626 (2000) 246 Ga. App. 386 UPSON COUNTY HOSPITAL, INC. v. HEAD. No. A00A1601. Court of Appeals of Georgia. October 13, 2000.

Gaulden v. Green, No. A12A1872 (Ga. Ct. App. Oct. 30, 2012)

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12 Years Old Girl Dies After Tonsillectomy

Tampa Bay Times reported on June 10, 2012 a 12 years old girl died after a tonsillectomy performed on Aug 13, 2010 for chronic tonsillitis. From the details provided from the news report, it seems that several independent issues all contributed together that lead to this child's unfortunate and tragic death.

This case was also complicated by subsequent non-medically related actions taken by medical personnel which will not be discussed here.

Strictly medically speaking...

Local Anesthetic With Epinephrine

It is unclear exactly when the local anesthetic bupivacaine (Marcaine) with epinephrine was injected into the tonsil region which may help with post-tonsillectomy pain control in the pediatric population. Also unclear is what concentration and how much got injected.

However, it is far from common practice (though not rare) and it is not something I personally inject in the pediatric population for a few reasons in spite of its well-known suspicion to minimize a sore throat after surgery. (There are plenty of papers that report such injection offers NO additional pain control in children. See references below.)

1) The risk of bupivacaine is toxicity to the heart leading to arrhythmias that may ultimately lead to a heart attack.
2) Epinephrine can result in hypertension as well as further exacerbate cardiac problems

Given report of "bloody froth" in the endotracheal tube along with acute onset of tachycardia and hypertension, I suspect the child suffered from pulmonary edema, most likely secondary to accidental intra-vascular injection of the local anesthetic (causing cardiac failure) and epinephrine (causing tachycardia and hypertension).

Given these risks and fact that kids are so much smaller and more susceptible to medication risks, I personally never inject this medication during/after tonsillectomy. Even in adults, I never inject routinely, though I do offer to adults undergoing tonsillectomy (but than I use bupivacaine alone without epinephrine).

The hypertension itself led to problem #2...

Congenital Cerebellar Vascular Anomaly

The child had a congenital cerebellar vascular anomaly that ruptured leading to a life-threatening bleed in the brain.

In and of itself, this anomaly would not have been a problem, but given the reported sudden hypertension, the rupture is akin to inflating a tire with too much air causing it to pop.

Most likely, if the child's cardiovascular compromise never occurred, this bleed never would have happened in the first place.

It's also entirely possible if the local anesthetic was never used, this death would not have happened as well.


Source:
Lawsuit claims doctors' mistakes caused Palm Harbor girl to die after tonsillectomy. Tampa Bay Times 6/10/12.


References:
Comparison of clonidine, local anesthetics, and placebo for pain reduction in pediatric tonsillectomy. Arch Otolaryngol Head Neck Surg. 2011 Jun;137(6):591-7. Epub 2011 Mar 21.

Preincisional bupivacaine in posttonsillectomy pain relief: a randomized prospective study. Arch Otolaryngol Head Neck Surg. 2002 Feb;128(2):145-9.

Control of early postoperative pain with bupivacaine in pediatric tonsillectomy. Ear Nose Throat J. 1993 Aug;72(8):560-3.

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Waking Up to NOT Just Major Colonoscopy Bills...

The New York Times published an article on May 28, 2012 regarding the high anesthesia charges associated with colonoscopy.

What people need to realize is that anesthesia charges apply not just to colonoscopy, but ANY procedure that requires general anesthesia... tonsillectomy, appendectomy, gallbladder surgery, ear tube placement in kids, etc.

With any procedure requiring general anesthesia, a patient is going to receive THREE bills... not just one which is what most reasonable people think.

1) A bill from the surgeon

2) A bill from anesthesia

3) A bill from the hospital

Sometimes the hospital and anesthesia charges are bundled into a single bill.

Often, patients mistakenly focus on the surgeon's charges thinking that's where their largest out-of-pocket cost is going to lie. However, the surgeon's fee is almost always the lowest of the charges.

Let's take a look at the New York Time's article...

The GI doctors actually performing the colonoscopy procedure got paid around $200. The anesthesia charges were around $2000 or 10x more (note that insurance coverage was an issue in this article and IF insurance did cover, out-of-pocket charges would have been significantly lower).

And than... if the procedure is done in the hospital, the hospital charges will often be around $5000 or 25x more.

These charges are similar to that found for many ENT procedures as well including tonsillectomy. (Of note, all insurances that we participate with... the anesthesia group I work with also participates with.)

On a more personal note, I recently underwent a general surgical procedure myself performed under general anesthesia in the hospital and got the following charges (3 different bills):

1) Surgeon's charge of $425 of which I owed $148.54 (difference covered by insurance)
2) Anesthesia charge of $1,400 of which I owed $140 (difference covered by insurance)
3) Hospital charge of $3,710.25 of which I owed $559.05 (difference covered by insurance)

Now if anesthesia did not participate with my insurance company, than I would have been fully responsible for anesthesia's full charge of $1,400. This situation is what the New York Time's article mainly focused on.

SO what is a cost-conscious patient to do?

Rather than focusing on the surgeon doing the procedure, the biggest cost-savings will occur negotiating with the hospital followed by anesthesia.

OR... avoid having procedures done in the hospital altogether to avoid hospital charges followed by avoid general anesthesia if at all possible and stick with local anesthesia alone. You will than ONLY have to deal with surgical charges which the surgeon should be able to inform up-front.

WHY do surgeons do procedures in the hospital rather than the office?

Beyond patient and procedural factors which may require general anesthesia, procedures may preferentially be performed in the hospital due to money. No big surprise there, but it may not be for the reasons people may suspect.

Let's take a real life example... balloon sinuplasty.

Balloon sinuplasty is an innovative minimally invasive surgical procedure to treat chronic sinusitis. Prior to 2011, this procedure was almost always performed in the operating room in the hospital though it could have been performed in the office.

Why?

The balloon used for this procedure costs around $2000 and is not reusable.

The reimbursement for the surgeon to perform this procedure was around $200+ depending on the number of sinuses addressed and insurance company.

SO... if balloon sinuplasty was performed in the office prior to 2011, the surgeon would have spent $2000 to do the procedure and than would have gotten paid only $200+ meaning a loss of ~$1800.

Why not charge the patient for the balloon device? Because it is called balance-billing and it is illegal.

So what is a surgeon to do if a patient desires balloon sinuplasty and yet the surgeon doesn't want to lose money?

You do it in the hospital... where the hospital eats the $2000 cost of purchasing the balloon device... and the surgeon still gets paid $200.

However, starting in 2012, insurance companies started reimbursing surgeons for the cost of the device which is why all of a sudden, balloon sinuplasty is now being performed in the office.

This type of financial calculation occurs all the time in medical offices.

Even a pediatrician's office where gardasil vaccination is often not offered... Why? Because the vaccine costs more than what the pediatrician will get reimbursed to give it.

Source:
Waking up to Major Colonoscopy Bills. New York Times 5/28/12

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In-Office Sinus Surgery Without General Anesthesia

There has been tremendous advances in sinus surgery over the past decade. From the elimination of nasal packing after most routine sinus surgery to the more recent use of balloons to open the sinus cavities, patient comfort has improved greatly after this particular operation. What used to be a several week recovery may now only be a few days.

Balloon sinuplasty in particular has been revolutionary in the surgical treatment of chronic sinusitis. Though sinus surgery normally is performed under general anesthesia, balloon sinuplasty now allows this operation to be performed awake WITHOUT sedation using local anesthesia only.

At its essence, sinus surgery "opens" up blocked sinus cavities to allow drainage and ventilation. Traditional sinus surgery "removes" tissue to accomplish this goal whereas balloon sinuplasty stretches open the sinus cavity without the need for tissue removal.

Given the lack of tissue removal with balloon sinuplasty, there is less pain and faster recovery after the procedure.

What are the steps?

After adequate anesthesia of the nose using both topical and injectable numbing medicine... Step 1 Under endoscopic guidance, the balloon catheter is introduced into the nasal cavity and guided towards the target sinus cavity opening. Depending on the system used, a sinus guidewire or sinus illumination may be used to help with the guidance.
Step 2 Once the sinus balloon catheter is correctly positioned across the blocked sinus opening, the balloon is gradually inflated to stretch open the ostia.
Step 3 After several seconds, the sinus balloon catheter is then deflated and removed leaving an enlarged sinus opening allowing for the return of sinus drainage. There is little to no disruption to mucosal lining.

Of course, not all patients are candidates for balloon sinuplasty, let alone this procedure to be done awake with local anesthesia alone.

In particular, balloon sinuplasty can only address blockages involving the frontal, maxillary, and sphenoid sinus cavities. Ethmoid sinus cavities can NOT be corrected using this method.

Also, balloon sinuplasty does not allow for tissue biopsies (by definition, the advantage of balloon sinuplasty is the lack of need to remove any sinus or nasal tissues). As such, if there are any masses present including nasal polyps, traditional sinus surgery is the better way to go.

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Tonsillectomy Circa 1940s [video]

I encountered this interesting video of tonsillectomy being performed in a child with sedation (but NO intubation) performed circa 1940s.


Of course, nowadays, tonsillectomy is performed under general anesthesia with intubation for airway protection. Here's a video of the way it is now done.

That is, unless, you practice in other parts of the world where modern medicine is not up to United States standards. In those nations, tonsillectomy is STILL being performed WITHOUT general anesthesia or any sedation for that matter. In fact, here's a blog I wrote earlier this year showing a graphic video depicting tonsillectomy being recently performed in a young child WITHOUT any sedation.

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Sedated Anesthesia for Kids Under 2 Years May Cause Learning Disability

There is mounting evidence in animals and in humans that general anesthesia might damage developing young brains.

Researchers at Mayo Clinic compared the learning skills of 350 kids who underwent 1 or more general anesthesia before age 2 to 700 kids who have never been under sedated (general) anesthesia. What they found was that before the age of 19 (after statistical normalization):

No significant difference in learning disability between kids who have been under anesthesia once (23 out of 100) with kids who have never been under anesthesia (21 out of 100).  

However, those kids who have been under anesthesia 2 or more times had increased rate of learning disability (36 out of 100). 

Based on animal studies, anesthetics are known to cause accelerated loss of brain cells during development which leads to learning and behavior problems later in life. Whether that's also true for humans has not been studied.

However, further study is required as the results were obtained based on observation and did not account for other variables (type of surgery for example).

This information, though not definitive, does warrant extra circumspection by parents and surgeons when deciding to pursue surgery in kids under age 2 years, no matter how minor the surgery including ear tubes, tonsillectomy, adenoidectomy, and turbinate reduction.

IF surgery pursued, one should perform as much as required to minimize need for a 2nd procedure at a later date. That means multiple procedures under one anesthesia would be preferable than multiple procedures at different times.

Of course, surgery should only be done if the benefits outweigh the risks including anesthetic risks.

Read the MSNBC report here.

Reference:
Cognitive and Behavioral Outcomes After Early Exposure to Anesthesia and Surgery. Published online in Pediatrics October 3, 2011. doi: 10.1542/peds.2011-0351

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