Despite considerable controversy over the use of Diprivan® (propofol) for endoscopies without an anesthesiologist present, there were few serious problems in almost 650,000 procedures where trained registered nurses administered the sedation under the direction of the doctor performing the exam.
Only 11 patients needed a tube inserted in their throats to help them breathe, and there were 4 deaths, all of them during upper endoscopies in seriously ill patients. There were no permanent neurological injuries.
Costs for using an anesthesiologist or nurse-anesthetist for all of the studied procedures would have reached nearly $185 million.
The FDA-approved labeling for Ditropan calls for a it to be administered only by “persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure.” However, it is increasingly being used during upper endoscopies and colonoscopies when doctors doing the test supervise registered nurses specially trained in giving the drug.
Douglas Rex, MD, FACG and his team reviewed safety information from all 223,656 published cases of endoscopist-directed propofol (EDP). In addition, they surveyed 28 centers in 17 countries that had prospectively kept records of the use of EDP and its safety and found another 422,424 cases.
In all those cases there were four deaths and no instances of permanent neurological damage. Eleven patients needed a breathing tube inserted.
The four deaths all occurred during upper endoscopies. Two were in patients with advanced pancreatic cancer, one patient was severely mentally retarded, and the fourth patient who died had advanced heart disease and a history of substance abuse. The death rate for all patients in the study was 1 in 161,515 cases.
The research team also reviewed published safety studies for the more common sedation used for endoscopy and found death rates of 1 in 1,000 to 1 in 11,000. The most recent safety study included information from 324,737 cases where opioids and benzodiazepines were used for gastrointestinal endoscopy and found 39 deaths or 11 per 100,000, including 28 cardiac deaths.
Using the average cost of an anesthesia specialist to deliver propofol sedation of $286, it would had cost $184,778,880 if specialists had been necessary for all 646,080 procedures. The researchers estimated that the cost per life year saved would have been over $2.6 million. Even if the anesthesia specialists had only been used in the most serious cases, the cost per life year saved would have been over half a million dollars.
In addition to the 11 patients who needed a breathing tube, another 489 required an oxygen mask and bag ventilation during their exam. Mask-bag ventilation was necessary ten times as often during upper endoscopies as colonoscopies. Only 20 patients needed the mask-bag assistance during a colonoscopy.
Dr. Rex and his colleagues concluded,
In conclusion, EDP is as safe or safer than endoscopist administered opioids and benzodiazepines, based on the available literature. Further, our findings on the safety of endoscopist-administered sedation show that the use of anesthesiologists for sedation for endoscopic procedures is costly.
However, they added,
We recommend that all individuals involved in the administration of propofol sedation receive appropriate training before using propofol.
SOURCE: Rex et al., Gastroenterology, Volume 147, Issue 4, October 2009.
Listen to Dr. Rex describe the study: