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全麻下全关节置换术后口服莫沙必利可提供额外的止吐疗效:一项随机、双盲临床试验。

Oral mosapride can provide additional anti-emetic efficacy following total joint arthroplasty under general anesthesia: a randomized, double-blinded clinical trial.

机构信息

Department of Orthopaedic Surgery, National Clinical Research Center for Geriatrics, West China Hospital, Sichuan University, No. 37 Guoxue Road, Chengdu, Sichuan Province, 610041, People's Republic of China.

Department of Orthopaedic Surgery, The First Affiliated Hospital of Zhengzhou University, No. 1 East Jianshe Road, Zhengzhou, 450052, People's Republic of China.

出版信息

BMC Anesthesiol. 2020 Dec 3;20(1):297. doi: 10.1186/s12871-020-01214-4.

Abstract

BACKGROUND

We sought to determine (1) whether the addition of prophylactic oral mosapride to a protocol including dexamethasone and ondansetron further reduces postoperative nausea and vomiting (PONV) compared with ondansetron alone or the combination of both; (2) whether preemptive application of oral mosapride provides additional clinical benefits for bowel function and appetite, thus improving functional recovery.

METHODS

We randomized 240 patients undergoing total hip and knee arthroplasty to receive placebo (Control, n = 80), dexamethasone (10 mg) before anesthesia induction (Dexa, n = 82), or dexamethasone (10 mg) before anesthesia induction as well as oral mosapride (5 mg) before and after surgery (Mosa+Dexa, n = 78). Patients were assessed at 0-6, 6-12, 12-24, and 24-48 h postoperatively. Primary outcomes were incidence and severity of PONV as well as complete response. Secondary outcomes were appetite, time until first defecation and ambulation, patient satisfaction score, and length of hospital stay.

RESULTS

Mosa+Dexa patients showed significantly lower incidence of nausea at 6-12 h (3.8%) and over the entire evaluation period (6.4%), as well as a higher rate of complete response (89.7%) than other patients. Mosa+Dexa patients required less time to achieve first defecation and ambulation, they were hospitalized for shorter time, and they were more satisfied with clinical care.

CONCLUSION

Addition of oral mosapride further reduced incidence of PONV, especially postoperative nausea, during 6-12 h postoperatively. Moreover, preemptive application of oral mosapride can further improve appetite, bowel function, ambulation and length of hospital stay.

TRIAL REGISTRATION

The study protocol was registered at the Chinese Clinical Trial Registry ( ChiCTR1800015896 ), prospectively registered on 27/04/2018.

摘要

背景

我们旨在确定(1)与单用昂丹司琼或昂丹司琼联合地塞米松相比,预防性口服莫沙必利是否进一步降低术后恶心和呕吐(PONV)的发生率;(2)预防性应用口服莫沙必利是否对肠道功能和食欲有额外的临床益处,从而改善功能恢复。

方法

我们将 240 名接受全髋关节和膝关节置换术的患者随机分为安慰剂组(对照组,n=80)、麻醉诱导前给予地塞米松(10mg)组(Dexa 组,n=82)和麻醉诱导前给予地塞米松(10mg)和手术前后给予莫沙必利(5mg)组(Mosa+Dexa 组,n=78)。患者在术后 0-6、6-12、12-24 和 24-48 小时进行评估。主要结局为 PONV 的发生率和严重程度以及完全缓解率。次要结局为食欲、首次排便和活动时间、患者满意度评分和住院时间。

结果

Mosa+Dexa 组患者在 6-12 小时(3.8%)和整个评估期间(6.4%)恶心的发生率明显较低,且完全缓解率(89.7%)较高。Mosa+Dexa 组患者首次排便和活动时间较短,住院时间较短,对临床护理的满意度较高。

结论

口服莫沙必利可进一步降低 PONV 的发生率,特别是在术后 6-12 小时内恶心的发生率。此外,预防性应用口服莫沙必利可进一步改善食欲、肠道功能、活动能力和住院时间。

试验注册

该研究方案在中国临床试验注册中心(ChiCTR1800015896)注册,于 2018 年 4 月 27 日进行了前瞻性注册。

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