ROBOT ANESTHESIA

Will robots replace anesthesiologists?

I am the Medical Director of a surgery center in California that does 5,000 gastroenterology endoscopies per year.  Recently a national marketing firm contacted me to seek my opinion regarding an automated device to infuse propofol.  The device was envisioned as a tool for gastroenterologist/nursing teams to use to administer propofol safely for endoscopy procedures on ASA class I – II patients.

The marketing firm could not reveal the name of the device, but I believe it was probably the SEDASYS®-Computer-Assisted Personalized Sedation System, developed by the Ethicon Endo-Surgery, Inc., a division of Johnson and Johnson.  The SEDASYS System is a computer-assisted personalized sedation system integrating propofol delivery with patient monitoring. The system incorporates standard ASA monitors, including end-tidal CO2, into an automated propofol infusion device.

The SEDASYS system is marketed as a device to provide conscious sedation.  It will not provide deep sedation or general anesthesia.

Based on pharmacokinetic algorithms, the SEDASYS infuses an initial dose of propofol (typically 30- 50 mg in young patients, or a smaller dose in older patients) over 3 minutes, and then begins a maintenance infusion of propofol at a pre-programmed rate (usually 50 mcg/kg/min).  If the monitors detect signs of over- sedation, e.g. falling oxygen saturation, depressed respiratory rate, or a failure of the end-tidal CO2 curve, the propofol infusion is stopped automatically.  In addition, the machine talks to the patient, and at intervals asks the patient to squeeze a hand-held gripper device.  If the patient is non-responsive and does not squeeze, the propofol infusion is automatically stopped.

As of February, 2013, the SEDASYS system was not FDA approved. On May 3, 2013, Ethicon Endo-Surgery, Inc. announced that the Food and Drug Administration (FDA) granted Premarket Approval for the SEDASYS® system, a computer-assisted personalized sedation system.  SEDASYS® is indicated “for the intravenous administration of 1 percent (10 milligrams/milliliters) propofol injectable emulsion for the initiation and maintenance of minimal to moderate sedation, as identified by the American Society of Anesthesiologists Continuum of Depth of Sedation, in adult patients (American Society of Anesthesiologists physical status I or II) undergoing colonoscopy and esophagoduodenoscopy procedures.”  News reports indicate that SEDASYS® is expected to be introduced on a limited basis beginning in 2014.

Steve Shaffer, M.D., Ph.D., Stanford Adjunct Professor, editor-in-chief of Anesthesia & Analgesia, and Professor of Anesthesiology at Columbia University, worked with Ethicon since 2003 on the design, development and testing of the SEDASYS System both as an investigator and as chair of the company’s anesthesia advisory panel.

Dr. Shafer has been quoted as saying, “The SEDASYS provides an opportunity for anesthesiologists to set up ultra-high throughput gastrointestinal endoscopy services, improve patient safety, patient satisfaction, endoscopist satisfaction and reduce the cost per procedure.” (Gastroenterology and Endoscopy News, November 2010, 61:11)

In Ethicon’s pivotal study supporting SEDASYS, 1,000 ASA class I to III adults had routine colonoscopy or esophagogastroduodenoscopy, and were randomized to either sedation with the SEDASYS System (SED) or sedation with each site’s current standard of care (CSC) i.e. benzodiazepine/opioid combination.  The reference for this study is Gastrointest Endosc. 2011 Apr;73(4):765-72. Computer-assisted personalized sedation for upper endoscopy and colonoscopy: a comparative, multicenter randomized study. Pambianco DJVargo JJPruitt REHardi RMartin JF.

In this study, 496 patients were randomized to SED and 504 were randomized to CSC. The area under the curve of oxygen desaturation was significantly lower for SED (23.6 s·%) than for CSC (88.0 s·%; P = .028), providing evidence that SEDASYS provided less over-sedation than current standard of care with benzodiazepine/opioid.  SEDASYS patients were significantly more satisfied than CSC patients (P = .007). Clinician satisfaction was greater with SED than with CSC (P < .001). SED patients recovered faster than CSC patients (P < .001). The incidence of adverse events was 5.8% in the SED group and 8.7% in the CSC group.

Donald E. Martin, MD, associate dean for administration at Pennsylvania State Hershey College of Medicine and chair of the Section on Clinical Care at the American Society of Anesthesiologists (ASA), expressed concerns about the safety of the device.  Dr. Martin (Gastroenterology and Endoscopy News, November 2010, 61:11) was quoted as saying, “SEDASYS is requested to provide minimal to moderate sedation and yet the device is designed to administer propofol in doses known to produce general anesthesia.”

Dr. Martin added that studies to date have shown that some patients who had  propofol administered by SEDASYS experienced unconsciousness or respiratory depression (Digestion 2010;82:127-129, Maurer WG, Philip BK.). In the largest prospective, randomized trial evaluating the safety of the device compared with the current standard of care, five patients (1%) experienced general anesthesia with SEDASYS. The ASA also voiced concern that SEDASYS could be used in conditions that do not comply with the black box warning in the propofol label, namely that propofol “should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure.”

Anesthetists, emergency room doctors, and trauma helicopter nurses are trained in the administration of general anesthesia. Gastroenterologists and endoscopy nurses are almost never experts in airway management.  For this reason, propofol anesthetics for endoscopy are currently the domain of anesthesiologists and nurse anesthetists.

In my phone conversation regarding the automated propofol-infusion system, I told the marketing company’s representative that in my opinion a machine that infused propofol without an airway expert present could be unsafe.  The marketing consultant responded that in parts of the Northeastern United States, including New York City, many GI endoscopies are done with the assistance of an anesthesia provider administering propofol.  If SEDASYS were to be approved, the devices could replace anesthesiologists.

In the current fee-for-service model of anesthesia billing, anesthesiologists and CRNA’s bill insurance companies or Medicare for their professional time.  If machines replace anesthesiologists and CRNA’s, the anesthesia team cannot send a fee-for-service bill for professional time.  The marketing consultant foresaw that with the advent of ObamaCare and Accountable Care Organizations, if a health care organization is paid a global fee to take care of a population rather than being paid a fee-for-service sum, then perhaps the cheapest way to administer propofol sedation for GI endoscopy would be to replace anesthesia providers with SEDASYS machines.

A planned strategy is to have gastroenterologists complete an educational course that would educate them on several issues.  Key elements of the course would be: 1) anesthesiologists are required if deep sedation is required, 2) SEDASYS is not appropriate if the patient is ASA 3 or 4 or has severe medical problems, 3) SEDASYS is not appropriate if the patient has risk factors such as morbid obesity, difficult airway, or sleep apnea, and 4) airway skills are to be taught in the simulation portion of the training.  Specific skills are chin life, jaw thrust, oral airway use, nasal airway use, and bag-mask ventilation.  Endotracheal intubation and LMA insertion are not to be part of the class.  If the endoscopist cannot complete the procedure with moderate sedation, the procedure is to be cancelled and rescheduled with an anesthesia provider giving deep IV sedation.

Some anesthesiologists are concerned about being pushed out of their jobs by nurse anesthetists.  It may be that some anesthesiologists will be pushed out of their jobs by machines.

I’ve been told that the marketing plan for SEDASYS is for the manufacturer to give the machine to a busy medical facility, and to only charge for the disposable items needed for each case. The disposable items would cost $50 per case. In our surgery center, where we do 5,000 cases per year, this would be an added cost of $25,000 per year. There would be no significant savings, because we do no use anesthesiologists for most gastroenterology sedation.

There have been other forays into robotic anesthesia, including:

1) The Kepler Intubation System (KIS) intubating robot, designed to utilized video laryngoscopy and a robotic arm to place an endotracheal tube (Curr Opin Anaesthesiol. 2012 Oct 25. Robotic anesthesia: not the realm of science fiction any more. Hemmerling TMTerrasini N. Departments of Anesthesia, McGill University),

2) The McSleepy intravenous sedation machine, designed to administer propofol, narcotic, and muscle relaxant to patients to control hypnosis, analgesia, and muscle relaxation. (Curr Opin Anaesthesiol. 2012 Dec;25(6):736-42. Robotic anesthesia: not the realm of science fiction any more. Hemmerling TMTerrasini N.)

3) The use of the DaVinci surgical robot to perform regional anesthetic blockade. (Anesth Analg. 2010 Sep;111(3):813-6. Epub 2010 Jun 25. Technical communication: robot-assisted regional anesthesia: a simulated demonstration. Tighe PJBadiyan SJLuria IBoezaart APParekattil S.).

4) The use of the Magellan robot to place peripheral nerve blocks (Anesthesiology News, 2012, 38:8)

Each of these applications may someday lead to the performance of anesthesia by an anesthesiologist at geographical distance from the patient.  In an era where 17% of the Gross National Product of the United States is already being spent on health care, one can question the logic of building expensive technology to perform routine tasks like I.V. sedation, endotracheal intubation, or regional block placement.  The new inventions are futuristic and interesting, but a DaVinci surgical robot costs $1.8 million, and who knows what any of these anesthesia robots would sell for?  The devices seem more inflationary than helpful at this point.

Will robots replace anesthesiologists?  Inventors are edging in that direction.  I would watch the peer-reviewed anesthesia journals for data that validates the utility and safety of any of these futuristic advances.

It will be a long time before anyone invents a machine or a robot that can perform mask ventilation.  SEDASYS is designed for conscious sedation, not deep sedation or general anesthesia.  Anyone or anything that administers general anesthesia without expertise in mask ventilation and all facets of airway management is courting disaster.

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Introducing …  THE DOCTOR AND MR. DYLAN, Dr. Novak’s debut novel, a medical-legal mystery which blends the science and practice of anesthesiology with unforgettable characters, a page-turning plot, and the legacy of Nobel Prize winner Bob Dylan.

Publication date September 9, 2014 by Pegasus Books.

On October 2, 2014 THE DOCTOR AND MR. DYLAN became the world’s  #1 bestselling anesthesia Kindle book on Amazon.com.

To reach the Amazon webpage, click on the book image below:

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Stanford professor Dr. Nico Antone leaves the wife he hates and the job he loves to return to Hibbing, Minnesota where he spent his childhood. He believes his son’s best chance to get accepted into a prestigious college is to graduate at the top of his class in this remote Midwestern town. His son becomes a small town hero and academic star, while Dr. Antone befriends Bobby Dylan, a deranged anesthetist who renamed and reinvented himself as a younger version of the iconic rock legend who grew up in Hibbing. An operating room death rocks their world, and Dr. Antone’s family and his relationship to Mr. Dylan are forever changed.

Equal parts legal thriller and medical thriller, The Doctor and Mr. Dylan examines the dark side of relationships between a doctor and his wife, a father and his son, and a man and his best friend. Set in a rural Northern Minnesota world reminiscent of the Coen brothers’ Fargo, The Doctor and Mr. Dylan details scenes of family crises, operating room mishaps, and courtroom confrontation, and concludes in a final twist that will leave readers questioning what is of value in the world we live in.

REVIEWS:

5.0 out of 5 stars The Doctor and Mr Dylan, March 3, 2015
By
prabha venugopal (chicago, il USA) – See all my reviews
Verified Purchase(What’s this?)
Gripping from the beginning to the end. Very well written, bringing to the forefront all the human emotions seen in an operating room spill over into real life. I cannot wait for Dr. Novak to wrote another book! As another physician in the same profession, my admiration for his book knows no limits.

 

Bang-Up Debut Novel, November 16, 2014

By Norm Goldman “Publisher & Editor of Bookpleasures”

This part legal and medical thriller is structured with a mixed bag of situations involving relationships, jealousy, evil, lies, courtroom drama, operating room mishaps as well as moments that engender conflicting and unexpected outcomes. Noteworthy is that as the suspense builds readers will become eager to uncover the truth involving a mishap concerning Nico and a surgical procedure that has unanticipated ramifications.

This is a bang-up debut from a writer who understands timing and is able to deliver hairpin turns, particularly involving the courtroom drama,that you would expect from a book of this genre.

 

TwinCities.com PIONEER PRESS Entertainment

by Mary Ann Grossman, Entertainment Editor, St. Paul Pioneer Press mgrossman@pioneerpress.com, January 4, 2015

“The Doctor & Mr. Dylan” by Rick Novak (Pegasus Books, $17.50)

Dr. Nico Antone doesn’t hide the fact he hates his wife, but he says he didn’t kill her during an operation. The authorities think otherwise and his trial is the riveting suspense in this novel that is part medical thriller, part legal thriller, part exploration of family relationships.

Nico is an anesthesiologist (as is the author) who leaves his wife, their plush life in California and his job at Stanford to move to his hometown of Hibbing so their son, Johnny, has a better chance of getting into a prestigious college. Johnny hates the idea of moving to a small, cold town, but he’s popular from the first day in school. Nico doesn’t do so well. He’s envied by Bobby, an anesthetist who’s jealous of the better-educated Nico. But it’s hard to take Bobby seriously, since he thinks he’s the young Bob Dylan and lives in the house where Bobby Zimmerman grew up. To complicate matters, Nico is attracted to the mother of the young woman his son is dating. When the two teens get in trouble, Nico’s furious, rich wife comes to Minnesota and needs an emergency operation that puts her on Nico’s operating table.

Novak grew up in Hibbing, where he worked in the iron ore mines and played on the U.S. Junior Men’s Curling championship teams of 1974 and ’75. After graduating from Carleton College, he earned a medical degree at the University of Chicago and spent 30-plus years at Stanford Hospital, where he was an associate professor of anesthesia and Deputy Chief of the Anesthesia Department. His courtroom scenes are based on his experiences as an expert witness.

The Physician’s Late-Night Reading List

Two Pritzker alums pen captivating tales

By Brooke E. O’Neill, University of Chicago Pritzker School of Medicine, editir, Medicine on the Midway Magazine

For most physicians, writing — patient notes, case histories, perhaps journal articles — is part of the job. But for anesthesiologist-novelist Rick Novak, MD’80, and neurosurgeon-memoirist Moris Senegor, MD’82, it’s a second career that consumes early morning hours long before they step into the OR.

Fans of John Grisham will find a kindred spirit in Novak, whose fast-paced medical thriller, The Doctor & Mr. Dylan (Pegasus Books, 2014), transports readers to rural Northern Minnesota, where an accomplished physician and a deranged anesthetist who thinks he’s rock legend Bob Dylan see their worlds collide in the most unexpected ways.

Delivering real-life twists and turns — and a love letter to the Bay Area — is Senegor’s Dogmeat: A Memoir of Love and Neurosurgery in San Francisco (Xlibris, 2014), a coming-of-age tale chronicling the author’s away rotation with renowned neurosurgeon Charles Wilson, MD, at the University of California, San Francisco. Brutally honest, it spares no details of a time Senegor, who also served as a resident under the University of Chicago’s famed neurosurgery chair Sean Mullan, MD, describes as “one of the biggest failures of my life.”

One a vividly imagined nail-biter, the other an intimate peek into the surgical suite, both books deliver an ample dose of intensity and drama.

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The Doctor and Mr. Dylan (Pegasus Books, 2014) by Rick Novak, MD’80

“I thought it was a novel way of killing someone,” said Rick Novak, deputy chief of anesthesiology at Stanford University, describing the imagined hospital death that was the genesis of his dark thriller The Doctor & Mr. Dylan. A huge Bob Dylan fan — the rock icon was born in Novak’s hometown of Hibbing, Minnesota, where the story takes place — he then dreamed up a possible culprit: a psychotic anesthetist who thinks he’s Dylan.

From there, the words flowed. “I would write whenever I was with my laptop and had a free moment: in mornings, in evenings, in gaps between cases,” said Novak, who also blogs about anesthesia topics. “I don’t sleep much.”

After finishing the manuscript — one year to write, another to edit — came the challenge of finding a publisher. “In anesthesia, I’m an expert,” Novak said. “In the literary world, I’m an unknown.” After 207 responses of “no, thanks” or no answer at all, he landed an agent. Two months later, she informed him that Pegasus Books had bought his debut novel.

“I started crying,” Novak admits. “I have a third grader and at the time the big word the class was learning was ‘perseverance.’ That was it exactly.”

 

Dr. Joseph Andresen, Editor, Santa Clara County Medical Association Medical Bulletin, from the January/February 2015 issue:

BOOK REVIEW “THE DOCTOR AND MR. DYLAN”

This past month, Dr. Rick Novak handed me a hardbound copy of his debut novel The Doctor and Mr. Dylan. Rick and I go way back. It was my first week of residency at Stanford when we first met. A newcomer to the operating room, all the smells and sounds were foreign to me despite my previous three years in the hospital as an internal medicine resident. Rick, a soft spoken Minnesotan at heart, in his second year of residency, took me under his wing and guided me through those first few bewildering months, sharing his experience and wisdom freely.

Fast-forward 30 years later. Dr. Rick Novak, a novel and mystery author? This was new to me as I sat down and opened the first page of The Doctor and Mr. Dylan. I have to admit that I didn’t know what to expect. Few books highlight a physician/anesthesiologist as a protagonist, and few books feature a SCCMA member as a physician/author. However, a medical-mystery theme novel wasn’t at the top of my must read list. With my 50-hour workweek, living and breathing medicine, imagining more emotional stress and drama was the furthest thing from my mind. However, three days later, as I turned the last page, and read the last few words. “life is a series of choices. I stuck my forefinger into the crook of the steering wheel, spun it hard to the left and …” This completed my 72-hour journey of and free moments I had, completely immersed in this story of life’s disappointments, human imperfections, and simple joys.

Rick, I can’t wait for your next book. Bravo!

 

Hibbingite writes twisted medical tale

HIBBING — Readers who are looking for a whodunit that will keep them up all night are in for a treat.

Hibbing native Rick Novak recently released his first book “The Doctor and Mr. Dylan,” a fiction set in Hibbing that merges anesthesia complications, a tumultuous marriage and the legend of Bob Dylan.

“The dialogue is sometimes funny, and there are lots of plot twists,” he said.

Novak said the book will not only entertain readers, but teach them about anesthesiology, Dylanology, the stressful race for elite college admission, and life on the Iron Range.

“The book is very conversational and streamlined,” he said. “I try to write as one would tell a story out loud.”

Novak said “The Doctor and Mr. Dylan” took him three years to perfect. He is currently working on his second book.

 

5.0 out of 5 stars I Sense We Have Another F.Scott Fitzgerald Emerging on the Literary Scene, December 1, 2014
By
Deann Brady (Sunnyvale, CA USA) – See all my reviews
(REAL NAME)
I found Rick Novak’s first novel, “The Doctor and Mr. Dylan,” a most exciting combination of biting sarcasm, mystery and daily activity spun with fresh new phrases that made me turn my ear back to listen to the literary cadence of his words again and again even though, on the other hand, I was anxious to turn the pages to see what would happen next. His brilliant handling of scenes is reminiscent of The Great Gatsby by F. Scott Fitzgerald. A compelling read!Deany Brady, author of “An Appalachian Childhood”

 

 

By

allan mishra

This review is from: The Doctor and Mr. Dylan (Kindle Edition)

Just finished Dr. Novak’s delightful novel. I sincerely enjoyed his honest take about the pressures and values that exist within California’s Silicon Valley. He also brought the North Country of Minnesota to life with memorable characters and a twisting, addictive plot. Buried beneath the fun and funny story is a deeper message about how to best care for your kids, your relationships and yourself. Very well written and highly recommended.

 

Learn more about Rick Novak’s fiction writing at rick novak.com by clicking on the picture below:

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