地塞米松剂量与乳房切除术术后早期恢复：一项双盲、随机试验。

Dexamethasone Dose and Early Postoperative Recovery after Mastectomy: A Double-blind, Randomized Trial.

机构信息

From the Department of Anesthesiology, Centre for Cancer and Organ Diseases (K.J.S., H.N.A., E.K.A.) Surgical Pathophysiology Unit (K.J.S., H.K.) Department of Anesthesiology, Centre of Head and Orthopaedics (H.A.), Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark Department of Breast Surgery, Herlev/Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark (N.K.).

出版信息

Anesthesiology. 2020 Apr;132(4):678-691. doi: 10.1097/ALN.0000000000003112.

DOI:10.1097/ALN.0000000000003112

PMID:31977520

Abstract

BACKGROUND

Pain and nausea are the most common challenges in postoperative recovery after mastectomy. Preventive measures include multimodal analgesia with preoperative glucocorticoid. The aim of this study was to investigate whether 24 mg of preoperative dexamethasone was superior to 8 mg on early recovery after mastectomy in addition to a simple analgesic protocol.

METHODS

In a randomized, double-blind trial, patients 18 yr of age or older having mastectomy were randomized 1:1 to 24 mg or 8 mg dexamethasone, and all received a standardized anesthetic and surgical protocol with preoperative acetaminophen, total intravenous anesthesia, and local anesthetic wound infiltration. The primary endpoint was number of patients transferred to the postanesthesia care unit according to standardized discharge criteria (modified Aldrete score). Secondary endpoints included pain and nausea at extubation, transfer from the operating room and upon arrival at the ward, length of stay, seroma occurrence, and wound infections.

RESULTS

One hundred thirty patients (65 in each group) were included and analyzed for the primary outcome. Twenty-three (35%) in each group met the primary outcome, without significant differences in standardized discharge scores (odds ratio, 1.00 [95% CI, 0.49 to 2.05], P > 0.999). More patients had seroma requiring drainage in the 24 mg versus 8 mg group, 94% versus 81%, respectively (odds ratio, 3.53 [95% CI, 1.07 to 11.6], P = 0.030). Median pain scores were low at all measured time points, numeric rating scale less than or equal to 2 versus less than or equal to 1 in the 24 mg versus 8 mg group, respectively. Six patients in each group (9%) experienced nausea at any time during hospital stay (P > 0.999). Length of stay was median 11 and 9.2 h in the 24 and 8 mg group, respectively (P = 0.217).

CONCLUSIONS

The authors found no evidence of 24 mg versus 8 mg of dexamethasone affecting the primary outcome regarding immediate recovery after mastectomy. The authors observed a short length of stay and low pain scores despite a simple analgesic protocol.

摘要

背景

疼痛和恶心是乳房切除术后恢复过程中最常见的挑战。预防措施包括术前使用糖皮质激素的多模式镇痛。本研究的目的是探讨在常规镇痛方案基础上，术前使用 24mg 地塞米松是否优于 8mg 对乳房切除术后早期恢复的影响。

方法

在一项随机、双盲试验中，18 岁及以上接受乳房切除术的患者被随机分为 1:1 的 24mg 或 8mg 地塞米松组，所有患者均接受标准化的麻醉和外科方案，包括术前对乙酰氨基酚、全静脉麻醉和局部麻醉伤口浸润。主要终点是根据标准化出院标准（改良 Aldrete 评分）转移至麻醉后恢复室的患者人数。次要终点包括拔管时、离开手术室时和到达病房时的疼痛和恶心程度、住院时间、血清肿发生和伤口感染。

结果

共纳入并分析了 130 例患者（每组 65 例）的主要结局。两组中各有 23 例（35%）达到主要结局，标准化出院评分无显著差异（优势比，1.00[95%CI，0.49 至 2.05]，P＞0.999）。24mg 组需要引流的血清肿患者多于 8mg 组，分别为 94%和 81%（比值比，3.53[95%CI，1.07 至 11.6]，P=0.030）。所有测量时间点的疼痛评分均较低，24mg 组的数字评分量表均为 2 或以下，8mg 组为 1 或以下。两组各有 6 例（9%）患者在住院期间任何时间出现恶心（P＞0.999）。24mg 和 8mg 组的住院时间中位数分别为 11 和 9.2 小时（P=0.217）。