Background

Clinically significant postoperative nausea and vomiting (PONV) is a patient-reported outcome which reflects patient experience. Although dexamethasone prevents PONV, it is unknown what impact it has on this experience.

Methods

In this prespecified embedded superiority substudy of the randomised Perioperative Administration of Dexamethasone and Infection (PADDI) trial, patients undergoing non-urgent noncardiac surgery received dexamethasone 8 mg or placebo intravenously after induction of anaesthesia, and completed a validated PONV questionnaire. The primary outcome was the incidence of clinically significant PONV on day 1 or day 2 postoperatively. Secondary outcomes included the incidence of clinically significant PONV and severe PONV on days 1 and 2 considered separately.

Results

A total of 1466 participants were included, with 733 patients allocated to the dexamethasone arm and 733 to matched placebo. The primary outcome occurred in 52 patients (7.1%) in the dexamethasone arm and 66 (9%) patients in the placebo arm (relative risk [RR]=0.79; 95% confidence interval [CI], 0.56–1.11; P=0.18). Severe PONV occurred on day 2 in 27 patients (3.9%) in the dexamethasone arm and 47 patients (6.7%) in the placebo arm (RR=0.58; 95% CI, 0.37–0.92; P=0.02; number needed-to-treat (NNT)=36.7; 95% CI, 20–202). In the entire cohort of 8880 PADDI patients, lower nausea scores, less frequent administration of antiemetics, and fewer vomiting events were recorded by patients in the dexamethasone arm up to day 2 after surgery.

Conclusions

Administration of dexamethasone 8 mg i.v. did not influence clinically significant PONV. Dexamethasone administration did, however, decrease the incidence and severity of PONV, and was associated with less frequent administration of antiemetic agents.

Clinical trial registration

ACTRN12614001226695.

中文翻译：

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地塞米松与临床上显着的术后恶心和呕吐：随机围手术期给药地塞米松和感染 (PADDI) 试验的预设子研究

背景

具有临床意义的术后恶心和呕吐 (PONV) 是患者报告的结果，反映了患者的体验。尽管地塞米松可以预防 PONV，但尚不清楚它对这种体验有何影响。

方法

在这项预先指定的随机围手术期地塞米松给药和感染 (PADDI) 试验的嵌入优势子研究中，接受非紧急非心脏手术的患者在麻醉诱导后接受 8 mg 地塞米松或安慰剂静脉注射，并完成了经过验证的 PONV 问卷。主要结果是术后第 1 天或第 2 天有临床意义的 PONV 的发生率。次要结局包括分别考虑的第 1 天和第 2 天有临床意义的 PONV 和严重 PONV 的发生率。

结果

总共包括 1466 名参与者，其中 733 名患者分配到地塞米松组，733 名患者分配到匹配的安慰剂组。主要结局发生在地塞米松组的 52 名患者（7.1%）和安慰剂组的 66 名（9%）患者中（相对风险 [RR]=0.79；95% 置信区间 [CI]，0.56–1.11；P = 0.18 ）。第 2 天，地塞米松组 27 名患者 (3.9%) 和安慰剂组 47 名患者 (6.7%) 发生了重度 PONV (RR=0.58；95% CI，0.37–0.92；P = 0.02；需要的人数治疗 (NNT)=36.7；95% CI，20–202)。在 8880 名 PADDI 患者的整个队列中，直到手术后第 2 天，地塞米松组的患者记录到恶心评分较低、止吐药使用频率较低和呕吐事件较少。

结论

地塞米松 8 mg iv 给药不影响有临床意义的 PONV。然而，地塞米松给药确实降低了 PONV 的发生率和严重程度，并且与较少使用止吐剂有关。

临床试验注册

ACTRN12614001226695。