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LETTER TO THE EDITOR

Judgment and Risk to Patient in Study Design

Department of Anesthesiology Destin Surgery Center Destin, Florida sbudnyk949{at}aol.com

To the Editor:

I have concerns regarding safety of patients participating in a study reported by Mandel et al.1 According to the study design, "safety end points included arterial hemoglobin desaturation <85% for more than 60 s, hypotension <90 mm Hg systolic or 20% decrease from baseline persisting on repeat determination 1 min later, or inability to tolerate the procedure." In the discussion section, the authors clearly state, "clinicians would not normally elect to defer intervention during desaturation for 60 s". The design of the study is further complicated by the choice of midazolam-fentanyl as the control anesthetic. Perhaps fentanyl, midazolam and propofol administered by a skilled anesthesia provider would have been a more logical combination of drugs.

It is not clear in the methods section whether or not the nurse was allowed to intervene before these safety end points or these end points were used to determine when assistance from an anesthesiologist was to be requested. Also, patients known "to have significant co-morbidity were not explicitly excluded from the procedure."

Given the above, it is possible that the entire procedure could be performed while there were frequent episodes of SpO₂ <86% lasting <60 s without any interventions or consultation with an anesthesiologist. The authors cite two articles, Moller et al.2 and Severinghaus et al.,3 to justify/support the safety of their study design of planned nonintervention. Neither of these studies is on point, as neither was designed to test the safety or risks of prolonged hemoglobin oxygen desaturation.

Finally, were the patients aware that they would possibly undergo an anesthetic that "has been demonstrated to yield significant respiratory depression" with the primary end point of the study being whether or not they could recover under a certified nurse’s care?1 Is it ethical to compromise patient safety so that we can develop "an efficient sedation protocol" to increase throughput in procedure rooms, obtain greater patient acceptance, and decreased postanesthesia care unit costs?1 I believe prevention and early intervention are necessary in providing the safe anesthetics our patients have come to expect.

REFERENCES

1. Mandel JE, Tanner JW, Lichtenstein GR, Metz DC, Katzka DA, Ginsberg GG, Kochman ML. A randomized, controlled, double-blind trial of patient–controlled sedation with propofol/remifentanil versus midazolam/fentanyl for colonoscopy. Anesth Analg 2008;106:434–9[Abstract/Free Full Text]
2. Moller JT, Johannessen NW, Berg H, Espersen K, Larsen LE. Hypoxaemia during anesthesia-an observer study. Br J Anaesth 1991;66:437–44[Abstract/Free Full Text]
3. Severinghaus JW, Naifeh KH, Koh SO. Errors in 14 pulse oximeters during profound hypoxia. J Clin Monit 1989;5:72–81[Web of Science][Medline]

This Article Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in Web of Science Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Permissions Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Budnyk, S. A. Search for Related Content PubMed PubMed Citation Articles by Budnyk, S. A.