Trial reportFrontiers in pharmacology2026
Dexmedetomidine-flurbiprofen axetil-based opioid-free analgesia attenuates postoperative melatonin suppression and improves sleep quality after thyroidectomy: a randomized controlled trial.
Trial report in Frontiers in pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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8 authors.
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Abstract
Objective: To determine whether an opioid-free patient-controlled intravenous analgesia (PCIA) regimen based on dexmedetomidine and flurbiprofen axetil improves postoperative sleep quality and affects nocturnal melatonin secretion compared to a sufentanil-based regimen in patients undergoing thyroidectomy. Methods: In this prospective, randomized, double-blind controlled trial, 96 patients undergoing thyroidectomy were randomly assigned to receive either opioid-free PCIA (dexmedetomidine, flurbiprofen axetil, and ondansetron) or opioid PCIA (sufentanil and ondansetron). PCIA was initiated 5 min before the end of surgery. The primary outcome was postoperative sleep quality, assessed using the Richards-Campbell Sleep Questionnaire (RCSQ). Secondary outcomes included urinary 6-sulfatoxymelatonin (6-SMT) excretion normalized to creatinine, detailed sleep parameters, anxiety levels, pain intensity, sedation levels, and postoperative adverse events. Assessments of sleep quality, urinary 6-SMT excretion, and anxiety levels were performed preoperatively (T0) and on postoperative days 1 (T1) and 2 (T2). Pain intensity (assessed by the Visual Analog Scale, VAS) and sedation levels (assessed using the Ramsay Sedation Scale) were measured at postoperative hours 1, 6, 24, and 48. Results: Patients in the opioid-free group exhibited significantly higher RCSQ scores at T1 and T2, indicating improved postoperative sleep quality (all Conclusion: An opioid-free PCIA regimen based on dexmedetomidine and flurbiprofen axetil provides non-inferior postoperative analgesia while attenuating postoperative melatonin suppression, improving sleep quality, reducing anxiety, and decreasing opioid-related adverse events. This opioid-sparing strategy may represent an effective approach to enhance postoperative recovery after thyroidectomy. Clinical Trial Registration: https://www.chictr.org.cn, identifier ChiCTR2400079949. First Trial Tegistration: 01/17/2024.
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