摘要
目的 评价奥赛利定用于甲状腺癌根治术患者镇痛的效果.方法 采用前瞻性、随机、双盲、单中心、阳性对照的临床研究方法.选择2024年8月至10月于郑州大学附属肿瘤医院在全身麻醉下行甲状腺癌根治术患者84例,性别不限,年龄18～64岁,ASA分级Ⅰ或Ⅱ级,体质量50～70 kg且BMI18～28 kg/m2,受教育年限≥6年,预计手术时间＞1 h.采用随机数字表法分为2组:舒芬太尼组(S组,n=41)和奥赛利定组(O组,n=43).麻醉诱导时:S组静脉注射舒芬太尼15μg,O组静脉注射奥赛利定3 mg;若在气管插管后3 min内MAP或HR升高幅度超过基线值的20％,则追加舒芬太尼5 μg(S组)或奥赛利定1 mg(O组);切皮前2 min时:S组静脉注射舒芬太尼15μg,O组静脉注射奥赛利定3 mg.有效性评价指标:分别于气管拔管后5 min、出PACU即刻和术后24、48 h时记录动态疼痛视觉模拟量表(VAS)评分;分别于气管拔管后5、10、20和30 min时记录Ramsay镇静评分.安全性评价指标:术中血管活性药物使用情况和术后48 h内不良反应发生情况.结果 与S组相比,O组术后不同时点VAS评分和气管拔管后不同时点Ramsay评分差异无统计学意义(P＞0.05),术中阿托品使用率和术后恶心呕吐发生率降低(P＜0.05).结论 奥赛利定用于甲状腺癌根治术患者,可产生与舒芬太尼相当的术后镇痛效果,且术中血流动力学更加平稳,术后恶心呕吐发生率更低.
Abstract
Objective To evaluate the efficacy of oliceridine for analgesia in the patients undergo-ing radical thyroidectomy for thyroid cancer.Methods In this prospective,randomized,double-blind,sin-gle-center,positive-control study,84 patients of either sex,aged 18-64 yr,of American Society of Anes-thesiologists Physical Status classification Ⅰ or Ⅱ,weighing 50-70 kg,with a body mass index of 18-28 kg/m2,education years ≥ 6 yr,and expected surgery time＞1 h,with thyroid cancer undergoing radical surgery under general anesthesia at the Affiliated Cancer Hospital of Zhengzhou University from August to October 2024,were divided into 2 groups using a random number table method:sufentanil group(S group,n=41)and oliceridine group(O group,n=43).During anesthesia induction:Group S received intrave-nous injection of sufentanil 15 μg,while group O received intravenous injection of oliceridine 3 mg;If the increase in mean arterial pressure or heart rate exceeded 20％of the baseline value within 3 min after trache-al intubation,an additional 5 μg of sufentanil(S group)or 1 mg of oliceridine(O group)was added.At 2 min before skin incision,sufentanil 15 μg was intravenously injected in group S,and oliceridine 3 mg was intravenously injected in group O.Effectiveness evaluation indicators:The visual analog scale scores were recorded at 5 min after tracheal extubation,immediately upon exiting the post-anesthesia care unit,and at 24 and 48 h postoperatively;Ramsay sedation scores were recorded at 5,10,20 and 30 min after tracheal extubation.The safety evaluation indicators:The use of vasoactive drugs during surgery and occurrence of adverse reactions within 48 h after surgery were recorded.Results Compared with group S,no significant change was found in visual analog scale scores at different time points after surgery and Ramsay sedation scores at different time points after tracheal extubation(P＞0.05),and the usage rate of atropine during sur-gery and incidence of postoperative nausea and vomiting were significantly decreased in group O(P＜0.05).Conclusions Oliceridine can produce postoperative analgesic efficacy comparable to sufentanil in the pa-tients undergoing radical thyroidectomy for thyroid cancer,with smoother intraoperative hemodynamics and lower incidence of postoperative nausea and vomiting.
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