Posts Tagged ‘Airway obstruction’

You may have read about the recent tragic deaths of two healthy children – Marvelena Rady, age 3, and Caleb Sears, age 6 – in California dental offices. Unfortunately, they aren’t the first children to die during dental procedures, and unless things change, they probably won’t be the last.

State Senator Jerry Hill has asked the Dental Board of California (DBC) to review California’s present laws and regulations concerning pediatric dental anesthesia, and determine if they’re adequate to assure patient safety. Assemblymember Tony Thurmond has sponsored “Caleb’s Law”, seeking improved informed consent for parents.

On July 28, I had the opportunity to attend a stakeholder’s meeting at the Department of Consumer Affairs in Sacramento, to hear a presentation of the DBC’s report, and to be part of the delegation offering comments on behalf of the California Society of Anesthesiologists (CSA). We hope this is the beginning of some long overdue upgrades to the current regulations.

By long-standing California state law, dentists and oral surgeons are able to provide anesthesia services in their offices even for very young children or children with serious health issues. They may apply for one of four different types of permits for anesthesia:

General anesthesia

Adult oral conscious sedation

Pediatric oral conscious sedation

Parenteral conscious sedation.

But the route of administration – oral or intravenous – isn’t the point, especially for small children, and oral sedation isn’t necessarily safer. Sedation is a continuum, and there is no way of reliably predicting when a patient will fall asleep. Relaxation may turn into deep sedation, and deep sedation into a state of unresponsiveness which is equivalent to general anesthesia. Oral medications have led to deaths in children, sometimes even before the dental procedure has begun or well after it has finished. There’s no logic in California’s lower standards of emergency equipment and monitoring for procedures done under sedation as opposed to under general anesthesia.

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Since the death of comedian and talk-show host Joan Rivers, more information has surfaced about the events on the morning of August 28 at Yorkville Endoscopy. But key questions remain unanswered.

News accounts agree that Ms. Rivers sought medical advice because her famous voice was becoming increasingly raspy. This could be caused by a polyp or tumor on the vocal cords, or by acid reflux irritating the throat, among other possible causes.

So Ms. Rivers underwent an endoscopy by Dr. Lawrence B. Cohen, a prominent gastroenterologist, to evaluate her esophagus and stomach for signs of acid reflux. At the same time, a specialist in diseases of the ear, nose, and throat (ENT) reportedly examined her vocal cords (also known as vocal folds).

We don’t know exactly how much or what type of sedation Ms. Rivers’ may have received, though several news sources have reported that she was given propofol, the sedative associated with the death of Michael Jackson. No physician who specializes in anesthesiology has been identified on the team taking care of Ms. Rivers, and we don’t know who was in charge of giving her propofol.

It seems clear that at some point during Ms. Rivers’ endoscopy and vocal cord examination, there was a critical lack of oxygen in her bloodstream.

Was laryngospasm the cause?

Giving sedation for upper endoscopy is tricky, as any anesthesia practitioner will tell you. A large black endoscope takes up space in the mouth and may obstruct breathing. Any sedative will tend to blunt the patient’s normal drive to breathe. But most patients breathe well enough during the procedure, and go home with no complaints other than a mild sore throat.

News reports have speculated that the root cause of Ms. Rivers’ rapid deterioration during the procedure could have been laryngospasm. This term means literally that the larynx, or voice box, goes into spasm, and the vocal cords snap completely shut. No air can enter, and of course the oxygen in the bloodstream is rapidly used up.

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Movie buffs and science fiction fans certainly remember HAL, the computer in 1968’s hit movie “2001:  A Space Odyssey”.  Considered one of the greatest villains in film history, HAL was capable of reasoning and language processing to assist the astronauts on their space mission.  Ultimately, however, HAL decided that its best course of action was to kill all the astronauts. “I am putting myself to the fullest possible use,” said HAL, “which is all I think that any conscious entity can ever hope to do.”

Forty-five years later, the FDA in its wisdom has given premarket approval to the Sedasys® Computer-Assisted Personalized Sedation System, developed by Ethicon Endo-Surgery Inc.  The device has the potential to “redefine sedation delivery”, according to Ethicon’s press release, with propofol sedation “personalized to the needs of each patient, by precisely integrating drug delivery and comprehensive patient monitoring.”  The Sedasys device is designed for “healthy” adult patients who undergo colonoscopy and esophagogastroduodenoscopy (EGD) procedures electively.

Ethicon expects to introduce the system into clinical practice on a limited basis in 2014 to address “the growing preference for propofol sedation in gastroenterology by more closely matching the skill level of the sedation delivery team with the actual requirements of less complex cases.”

According to the FDA’s overview, the Sedasys is a “first-of-a-kind device that will allow non-anesthesia practitioners to administer propofol during colonoscopy and EGD procedures.”  It links clinical monitors to an IV infusion pump, and will automatically modify or stop the infusion if it detects “signs associated with oversedation” such as oxygen desaturation.

You don’t have to read much between the lines to conclude that the goal here is to make colonoscopies and EGDs cheaper by allowing people other than qualified anesthesia practitioners to administer propofol.

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It’s a nightmare that doesn’t end for the family of 24-year-old Marek Lapinski, who suffered cardiac arrest recently during the removal of two wisdom teeth in a southern California oral surgery clinic.  The former college football player had no known health problems prior to the surgery, but died three days later in a hospital intensive care unit.

While the circumstances of Mr. Lapinski’s death are still being investigated, the case highlights a critical issue.  Sedation and anesthesia carry risks, no matter how routine the surgery may be.  Patients are entitled to full disclosure about the qualifications of the personnel who will administer sedation or anesthesia for any procedure, and to a complete discussion of the risks and benefits of the type of anesthesia that will be used.  There may be minor operations, but there are no minor anesthetics.

Anesthesia that is given in hospitals is tightly regulated, but office-based surgery and dental clinics are not necessarily held to the same standards.  Regulations vary from state to state.  Perhaps the most worrisome aspect is that the same physician or dentist who is performing the surgery may be in charge of the anesthesia as well, directing an assistant who has no formal anesthesia certification to give powerful sedative medications.

According to a Fox 5 interview with Mr. Lapinski’s family, he began coughing during the wisdom tooth surgery, and then received propofol, a potent surgical anesthetic medication.  Shortly thereafter, the oxygen levels in his blood deteriorated, and he went into cardiac arrest.  His medical records were made public by the family, showing that Mr. Lapinski received other sedative medications including fentanyl, midazolam, ketamine, and methohexital in addition to propofol.

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