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Propofol safety similar to that of traditional sedatives used in endoscopy

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Propofol sedation not worth the cost

The use of propofol-mediated sedation and, in particular, anesthetist-directed sedation has become a hot-button item in the landscape of gastrointestinal endoscopy by virtue of its overall cost. Some experts place the cost of this at over $1.1 billion annually. Recent studies stemming from a large administrative database question the safety of propofol-mediated sedation when compared to the standard combination of a benzodiazepine and opioid. Still other studies have found that anesthesiologist-directed sedation did not improve the rate of polyp detection or polypectomy. Given these findings, our research group decided to embark upon a meta-analysis to further study the safety profile of propofol when compared to the combination of a benzodiazepine and opioid. We found that when compared to the traditional sedation agents, the pooled odds ratio of propofol-mediated sedation was not associated with a safety benefit in terms of the development of hypoxia or hypotension. We also found that the safety profile of propofol-mediated sedation was equivalent whether it was administered by a gastroenterologist or nongastroenterologist.

Dr. John Vargo

Does this answer the question? I think it is safe to say that for healthy patients undergoing elective upper endoscopy and colonoscopy that there is no safety benefit of propofol-mediated sedation compared with traditional agents. Our data also suggest that with appropriate patient selection and training that endoscopist-directed propofol sedation is a viable alternative to the traditional sedation with a combination of a benzodiazepine and opioid. The benefit of the agent may be its pharmacodynamics, which allow for a rapid targeting of the appropriate level of sedation and enhanced recovery, which lead to both augmented throughput and patient satisfaction. This has been well studied for endoscopist-directed propofol sedation when compared to traditional sedation regimens and may be true for anesthesiologist-directed sedation, although I know of no comparative data. Propofol sedation is a much more expensive alternative for healthy patients undergoing elective ambulatory endoscopy.

John Vargo, MD, MPH, is the department chair of gastroenterology and hepatology at Cleveland Clinic as well as vice chairman of Cleveland Clinic’s Digestive Disease Institute.


 

CLINICAL GASTROENTEROLOGY AND HEPATOLOGY

For doctors performing gastrointestinal endoscopic procedures, use of propofol as a sedative instead of the more commonly used drugs carries about the same risk of causing cardiopulmonary adverse events, according to a study published in the February issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2016.07.013).

“Because of its popularity, propofol is being used for both simple endoscopic procedures such as esophagogastroduodenoscopy and colonoscopy, and advanced endoscopic procedures [but] despite the widespread use of propofol, significant concerns remain regarding its safety profile,” according to the authors of the study, led by Vaibhav Wadhwa, MD, of Fairview Hospital in Cleveland.

The use of propofol as a sedative in gastrointestinal endoscopic procedures has increased in recent years, but because of an increasing number of advanced and, therefore, more complicated procedures being performed, the safety of sedatives has come into question because of their more prolonged use. Before use of propofol became prevalent, the more traditionally used sedative was a combination of benzodiazepine with an opioid. While still used today, this combination has seen a dramatic decline in usage because of its longer recovery time and lower rates of satisfaction among both patients and doctors, according to the authors. Combinations including midazolam, meperidine, pethidine, remifentanil, and fentanyl have also been used.

To compare the safety of propofol and a more traditional sedative combination, Dr. Wadhwa and his coauthors conducted a meta-analysis of published studies in the Medline (Ovid), EMBASE, and the Cochrane controlled trials registry databases. All searches were for research conducted through September of 2014, with the Medline database search starting in 1960, and the EMBASE and Cochrane searches starting in 1980, yielding a total of 2,117 studies eligible for inclusion.

Of those, 1,568 remained after duplicates were removed, then 136 were screened after removal of those deemed irrelevant or otherwise unsuitable. From those 136, 83 were excluded for various reasons – because they featured either ineligible populations, or were retrospective studies, single-arm studies, or conference abstracts – leaving 53 full-text articles to be evaluated for inclusion in the study. Of those, 27 were deemed eligible and were ultimately included.

“The primary outcomes measured were cardiopulmonary complications such as hypoxia, if oxygen saturation decreased to less than 90%; hypotension, if systolic blood pressure decreased to less than 90 mm Hg; arrhythmias, including bradycardia, supraventricular and ventricular arrhythmias, and ectopy,” Dr. Wadhwa and his coauthors wrote. “A subgroup analysis also was performed to assess studies in which sedation was directed by gastroenterologists and was compared with nongastroenterologists.” Apnea was not measured because of the lack of studies that assessed it qualitatively.

Pooled odds ratios were used to measure and compare results. The 27 included studies featured data on a total of 2,518 patients. Traditional sedatives were used on 1,194 of these subjects, while the remaining 1,324 received propofol. Regarding hypoxia, 26 of the 27 studies addressed this, of which 13 concluded that propofol was safer and 9 found that traditional sedatives were safer, with a pooled OR for propofol of 0.82 (95% confidence interval [CI] 0.63-1.07).

Twenty-five studies examined hypotension, of which 9 favored propofol and 10 favored traditional sedatives, for an OR of 0.92 (95% CI, 0.64-1.32). Of the 20 studies that included arrhythmia, 8 favored propofol and 7 favored traditional sedatives, for an OR of 1.07 (95% CI, 0.68-1.68).

“Our results showed that propofol sedation for gastrointestinal endoscopic procedures, whether simple or advanced, did not increase the cardiopulmonary adverse event rate when compared with traditional sedative agents,” the authors concluded.

In terms of the risk of developing any of the aforementioned complications, of the 20 relevant studies, 9 found propofol to be safer versus 6 that found traditional sedatives to be the better option, yielding an overall OR of 0.77 (95% CI, 0.56-1.07) for propofol. For the subanalysis regarding which type of clinician administered each sedative, 25 studies contained relevant data, of which 9 studies reported gastroenterologists administering sedatives, 5 studies reported endoscopy nurses administering sedatives under the supervision of the gastroenterologist, and 11 studies reported either an anesthesiologist, intensive care unit physician, or critical care physician administering sedatives.

“Gastroenterologist-directed sedation with propofol was noninferior to nongastroenterologist sedation,” Dr. Wadhwa and his coinvestigators wrote. “The risk of complications was similar to [that of traditional sedatives] both during simple and advanced endoscopic procedures.”

While the authors point to the sheer size of the study population as a huge strength of these results, they also note that because this is a study-level analysis rather than one conducted on an individual level, there is an inherent limitation to this study. Furthermore, variations from study to study in how propofol was administered to each patient may have caused heterogeneity with the findings of the meta-analysis. A large clinical trial would be the next logical step to affirm what this analysis has found.

“Because it may not be feasible to perform such a study, this meta-analysis should provide a rough idea of the possible associations,” the authors wrote. “However, the difference in complications between propofol and other agents might not be clinically relevant owing to the lack of any serious complications such as intubations or deaths in the studies used in this meta-analysis.”

No funding source was reported for this study. Dr. Wadhwa and his coauthors reported no relevant financial disclosures.

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