Park Jin Ha, Shim Jae-Kwang, Song Jong-Wook, Jang Jaewon, Kim Ji Hoon, Kwak Young-Lan
1. Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine.
2. Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei Cardiovascular Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.
Int J Med Sci. 2015 Sep 20;12(10):797-804. doi: 10.7150/ijms.12831. eCollection 2015.
Postoperative sore throat (POST) is a frequent complication of tracheal intubation, particularly after surgery in the prone position. We designed this study to validate the non-inferiority of magnesium sulphate against dexamethasone for prevention of POST after lumbar spinal surgery.
One hundred and forty-six patients were randomly allocated to receive either magnesium or dexamethasone. Before anesthetic induction, the magnesium group (n = 73) received magnesium sulphate 30 mg/kg followed by 10 mg/kg/h by continuous infusion until the end of surgery. The dexamethasone group (n = 73) received dexamethasone 8 mg. The primary endpoint was the overall incidence of POST, which was assessed serially over 48 hr postoperatively. The predefined margin of non-inferiority for magnesium against dexamethasone was 15%.
Overall incidences of POST at rest (50.7% versus 49.3% in the magnesium and dexamethasone group, respectively, p = 0.869) and swallowing (65.8% versus 61.6% in the magnesium and dexamethasone group, respectively, p = 0.606) were not different between the groups. The upper limit of the 90% confidence interval, which must be lower than the predefined margin of non-inferiority to prove the non-inferiority of magnesium sulphate against dexamethasone, for at rest and swallowing were 14.97% (p = 0.0496) and 17.19% (p = 0.0854), respectively. The incidences and severities of POST and hoarseness were also not different between the groups throughout the study period.
Prophylactic magnesium sulphate appears to be non-inferior to dexamethasone for the prevention of POST at rest in patients undergoing lumbar spinal surgery in the prone position.
术后咽痛（POST）是气管插管常见的并发症，尤其是在俯卧位手术后。我们设计了本研究，以验证硫酸镁预防腰椎手术术后POST不劣于地塞米松。
146例患者被随机分配接受硫酸镁或地塞米松治疗。麻醉诱导前，硫酸镁组（n = 73）静脉注射硫酸镁30 mg/kg，随后持续输注10 mg/（kg·h）直至手术结束。地塞米松组（n = 73）静脉注射地塞米松8 mg。主要终点是POST的总体发生率，术后48小时内连续评估。硫酸镁相对于地塞米松的非劣效性预设界值为15%。
两组静息时POST总体发生率（硫酸镁组为50.7%，地塞米松组为49.3%，p = 0.869）和吞咽时POST总体发生率（硫酸镁组为65.8%，地塞米松组为61.6%，p = 0.606）无差异。静息和吞咽时90%置信区间的上限分别为14.97%（p = 0.0496）和17.19%（p = 0.0854），必须低于非劣效性预设界值才能证明硫酸镁相对于地塞米松的非劣效性。在整个研究期间，两组POST和声音嘶哑的发生率及严重程度也无差异。
对于俯卧位腰椎手术患者，预防性使用硫酸镁预防静息时的POST似乎不劣于地塞米松。
