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REGIONAL ANESTHESIA AND PAIN MANAGEMENT

The Safety and Effectiveness of Remifentanil as an Adjunct Sedative for Regional Anesthesia

Marylin Lauwers, MD^*, Frederic Camu, MD^*, Harald Breivik, MD, Anders Hagelberg, MD, Michael Rosen, MD, FFARCS^§, Robert Sneyd, MD, FFARCS^||, Allan Horn, MD^¶, Druscilla Noronha, BSc^**, and Soraya Shaikh, PhD^**

*Department of Anesthesiology, Flemish Free University of Brussels Medical Center, Brussels, Belgium; Department of Anesthesiology, University of Oslo, Rikshospitalet, Oslo, Norway; Department of Anesthesia and Intensive Care, Norra Alvsborgs Länssjukhus, Trollhättan, Sweden; §Department of Anesthetics, University Hospital of Wales, Cardiff, United Kingdom; ||Department of Anesthesia, Derriford Hospital, Plymouth, United Kingdom; ¶Department of Anesthesia and Intensive Therapy, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark; and **Glaxo Wellcome Research and Development Ltd., Greenford, United Kingdom

Address correspondence and reprint requests to Frederic Camu, MD, Department of Anesthesiology, Flemish Free University of Brussels, School of Medicine, Laarbeeklaan 101-B-1090 Brussels, Belgium. Address e-mail to fcamu{at}anes.vub.ac.be

We assessed the sedative potential of continuous infusions of remifentanil with a validated composite alertness scale in 160 patients (ASA physical status I or II) undergoing hip replacement surgery with spinal block (n = 61) or hand surgery using brachial plexus block (n = 93). They were randomized to receive one of the following initial dose regimens in double-blinded fashion: placebo or 0.04, 0.07, or 0.1 µg · kg^-1 · min^-1 remifentanil subsequently titrated to effect. Additional midazolam IV was allowed for adequate sedation as required. The combined analysis of both surgery groups revealed a dose-related increase in achievement of sedation level 2 within 15 min of the start of the study drug infusion; all remifentanil dose comparisons with placebo reached significance (P < 0.001). The remifentanil 50% effective dose for a composite sedation level 2 within 15 min of the start of drug infusion was estimated as 0.043 µg · kg^-1 · min^-1 (95% confidence interval 0.01, 0.059). The requirement for midazolam decreased with increasing remifentanil dose compared with placebo (P < 0.001). The median time to return to alertness after the end of infusion was 10–12 min in the remifentanil groups and 5 min in the placebo group. Significant incidences of nausea, pruritus, sweating, and respiratory depression were reported during remifentanil infusions compared with placebo. The data suggest that remifentanil may be useful for supplementation of regional anesthesia, provided that ventilation is carefully monitored.

Implications: In this dose-finding, placebo-controlled study, remifentanil infusions were used to provide sedation during spinal and brachial plexus regional anesthesia. The 50% effective dose for achievement of sedation was 0.043 µg · kg^-1 · min^-1. Return to alertness occurred after 10–12 min (median time). Remifentanil infusions can be used to supplement regional anesthesia, but this requires careful monitoring of ventilation.

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