Journal
ANESTHESIA AND ANALGESIA
Volume 132, Issue 2, Pages 456-464Publisher
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1213/ANE.0000000000005108
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This study compared the pharmacokinetic and pharmacodynamic properties of different doses of buccal DEX gel in female patients undergoing modified radical mastectomy for breast cancer. The results showed that the 1 µg/kg dose of buccal DEX gel produced early postoperative sedation, lower heart rate values, and dose-dependent postoperative analgesia. Administering DEX formulated as an oral-mucosal gel sublingually 60-120 minutes before surgery may provide a safe and practical means of sedative premedication in adults.
BACKGROUND: Buccal dexmedetomidine (DEX) produces adequate preoperative sedation and anxiolysis when used as a premedication. Formulating the drug as a gel decreases oral losses and improves the absorption of buccal DEX. We compared pharmacokinetic and pharmacodynamic properties of 3 doses of buccal DEX gel formulated in our pharmaceutical laboratory for sedative premedication in women undergoing modified radical mastectomy for breast cancer. METHODS: Thirty-six patients enrolled in 3 groups (n = 12) to receive buccal DEX gel 30 minutes before surgery at 0.5 mu g/kg (DEX 0.5 group), 0.75 mu g/kg (DEX 0.75 group), or 1 mu g/kg (DEX 1 group). Assessments included plasma concentrations of DEX, and pharmacokinetic variables calculated with noncompartmental methods, sedative, hemodynamic and analgesic effects, and adverse effects. RESULTS: The median time to reach peak serum concentration of DEX (T-max) was significantly shorter in patients who received 1 mu g/kg (60 minutes) compared with those who received 0.5 mu g/kg (120 minutes; P = .003) and 0.75 mu g/kg (120 minutes; P = .004). The median (first quartile-third quartile) peak concentration of DEX (maximum plasma concentration [C-max]) in plasma was 0.35 ng/mL (0.31-0.49), 0.37 ng/mL (0.34-0.40), and 0.54 ng/mL (0.45-0.61) in DEX 0.5, DEX 0.75, and DEX 1 groups (P = .082). The 3 doses did not produce preoperative sedation. The 1 mu g/kg buccal DEX gel produced early postoperative sedation and lower intraoperative and postoperative heart rate values. Postoperative analgesia was evident in the 3 doses in a dose-dependent manner with no adverse effects. CONCLUSIONS: Provided that it is administered 60-120 minutes before surgery, sublingual administration of DEX formulated as an oral-mucosal gel may provide a safe and practical means of sedative premedication in adults.
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