The looming battle over sedation dentistry

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By Michelle Crouch

When Henry Patel, a cardiologist in Wilmington, went in for a tooth implant in July 2020, he didn’t think twice about allowing his oral surgeon to administer intravenous sedation.

During the procedure, however, the healthy 53-year-old’s oxygen saturation and heart rate dropped to dangerous levels, according to an investigation by the North Carolina Board of Dental Examiners. Then Patel stopped breathing. The surgeon, Mark Austin, tried to insert a breathing tube, but it went into Patel’s stomach, dental board documents say. Austin’s staff called 911, but they did not start CPR before paramedics arrived, according to the documents.

By then, 20 minutes later, Patel had no pulse. He was rushed to a local hospital but never regained consciousness. He died a few days later.

“I never thought I would go into a dental office and come back out a widow at age 47,” Patel’s wife, Shital Patel, said. “How could this happen?”

Patel is one of at least five North Carolina patients in the last decade to die of complications from dental sedation. A sixth death in Wake County from November 2021 is under investigation, and at least one other N.C. patient suffered permanent brain damage as a result of anesthesia complications, according to dental board records.

Although such cases are rare, the outcry over Patel’s death has prompted the dental board to propose new regulations that would dramatically change the way dentists and oral surgeons in North Carolina administer sedation.

If enacted, the new rules would be the strictest in the nation, according to a spokeswoman for the American Association of Oral and Maxillofacial Surgeons.

Dentists and oral surgeons, however, have sent dozens of letters opposing the changes, and they packed a February hearing to argue against them. They say there is no evidence the rules would increase safety, and they would drive up costs for patients.

The proposed changes “are not based on science,” said Bryan Neuwirth, an oral surgeon in Hickory who is president of the North Carolina Society of Oral and Maxillofacial Surgeons. “They will not enhance patient safety and will only do harm to our patients’ access to care.”

When a patient has other types of surgery, a physician does the operation while a second person with anesthesia training — usually an anesthesiologist or a certified registered nurse anesthetist (CRNA) — administers drugs and monitors the patient’s response.

But that’s not always the case with dental surgery.

Under the rules in North Carolina and every other state, dentists and oral surgeons who have received special anesthesia training are not required to have a second trained person present when they put a patient under.

Instead, dentists act as both the anesthesiologist and the surgeon during a procedure.

Critics say allowing them to serve in both roles concurrently endangers patients. They question how a dentist can vigilantly monitor vital signs when they are focused on the inside of a patient’s mouth performing a procedure such as a root canal, implant or tooth extraction.

Rob Harper, a cardiologist who worked with Patel and supports the stricter rules, said dentists should have to adhere to the same standard as doctors, especially since dental offices have less life-saving support than hospitals.

“There should be a single standard across healthcare,” he said.

The dental board is proposing a number of rules to enhance sedation safety, including requiring dentists to use a special instrument to measure carbon dioxide levels in a patient’s breath and requiring them to abide by maximum recommended dosages for anesthesia drugs.

But the rule generating the most controversy would require a second person with anesthesia training to monitor a dental patient during sedation.

If a patient is under light or moderate sedation, the second person could be a registered nurse or a dental assistant with special anesthesia training, the proposal says.

But if the dentist uses Propofol — a powerful, commonly used sedation drug — the second person would need to be someone with more training, such as an anesthesiologist, a CRNA, or a second dentist who holds a sedation permit.

Bobby White, the board’s CEO and legal counsel, said dentists often use Propofol for moderate sedation, in which patients are in a dreamlike state but still breathe on their own. Administering the right amount can be tricky, he explained, because it’s easy for patients to slip into a deeper, unintended level of sedation that stops their breathing.

White said the wording for the proposed rule actually just requires dentists and oral surgeons to follow the FDA-approved instructions for Propofol. Those instructions specifically say the person administering the drug “should not be involved in the surgical procedure.”

“The drug says on the warning label that if you use it, you should get someone to help you,” White said. “We are just saying, ‘Follow the label.’”

The American Society of Anesthesiologists also says patients should be continuously monitored by a second trained professional anytime they are put under moderate or deep sedation.

No law requires dentists and oral surgeons to follow the Propofol label. North Carolina would be the first state to require a separate anesthesia provider during an office-based dental or oral surgery procedure, a spokesperson for the American Association of Oral and Maxillofacial Surgeons said.

Harper, Patel’s former colleague, said he believes Patel may not have died if a second person with anesthesia training had been present. He worries dentists don’t have enough experience resuscitating patients when things go wrong. 

“If you don’t know how to reverse the effects of a complication, then you shouldn’t be doing the procedure at all, or at least you should be in a hospital surrounded by people who can,” Harper said.

Oral surgeons and dentists say a secondary anesthesia provider isn’t necessary because dental sedation is exceedingly safe, and deaths are rare. “In over 3 million anesthetics in North Carolina, there were six deaths — an extremely low number,” said Debra Sacco, an oral and maxillofacial surgeon who practices in Chapel Hill.

There is no national registry of sedation-related dental deaths. A 2017 Mayo Clinic analysis of 17,634 dental sedations found no deaths and 16 adverse events — a complication rate of 0.1%.

In North Carolina, there have been 27 reported adverse occurrences since 1990 that resulted dental patients being transferred to a hospital, the dental board said.

Sacco described the dentists and oral surgeons whose patients died as “outliers” who were not following established standards of care, and who are no longer practicing.

Mark Austin, the oral surgeon who operated on Patel, permanently lost his North Carolina dental license in August 2021 after a dental board investigation. In addition to taking actions that caused Patel’s death, Austin was also improperly prescribing narcotics to his staff and using them himself, according to a dental board consent order.

Austin did not respond to a request for comment.

Wes Parker, an oral surgeon in Davie County, said if the new rules pass, they would make it difficult for him to practice.

“Being in a rural and low-income North Carolina county, there are no readily available secondary anesthesia providers, nurse anesthetists, dental anesthesiologists or medical anesthesiologists that can come to my office, especially on short notice,” he said.

In addition, the increased cost would prompt many patients to delay or forgo dental work they need, he said.

“Patient care will be delayed and access to care will be diminished,” Parker said. “Delays in care for a dental infection can result in significant complications, hospitalization and even death.”

The North Carolina Board of Dental Examiners is expected to vote on the stricter standards in April. After that, the new rules will be sent to the General Assembly’s Rules Review Commission, which will vote whether to approve them based on whether they are clear, necessary and within the dental board’s authority.

No matter how the commission votes, if 10 people file written objections to the new rules (which is likely, White said, given the strong opinions on both sides), the proposal will be sent to the state legislature for a final decision.

That means N.C. lawmakers could make the final call on the change, and it may be months before the issue is decided.

No matter what happens, Shital Patel said she hopes sharing her husband’s story will prompt patients to ask questions before they agree to dental sedation such as: Will another dentist, anesthesiologist or CRNA be in the room if something goes wrong? What type of drugs are you using and are they reversible? Who will monitor my vital signs? What are your emergency procedures?

“Even though my husband was a physician, we didn’t think to ask this type of question,” Shital Patel said. “Let’s all learn something from this. Maybe there have been only a few deaths, but even one death is too many.” 

Michelle Crouch is a freelance writer and a regular contributor to The Ledger who often writes about healthcare. Send her story tips at [email protected].

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Stephen De May, president of Duke Energy’s utility operations in North Carolina, speaking at the Hood Hargett Breakfast Club last week in response to a question from the audience:

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It’s time for our monthly installment of “Where are developers building apartments and townhouses now?” — otherwise known as the monthly rezoning filings with the city.

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In February, developers filed rezoning plans with the city for more than 2,000 housing units. The plans include:

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