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单孔腹腔镜全子宫切除术后预防性注射雷莫司琼预防恶心呕吐的前瞻性随机研究

Scheduled injection of ramosetron for prevention of nausea and vomiting following single-port access total laparoscopic hysterectomy: a prospective randomized study.

作者信息

Li Shoou-Chern, Wang Youngmi, Choi Seong Jin, Jung Yeon Soo, Han Kyoung-Hee, Chung In Bai, Lee San-Hui

机构信息

Department of Obstetrics and Gynecology, Yonsei University Wonju College of Medicine, Wonju, Korea.

Department of Obstetrics and Gynecology, National Health Insurance Service Ilsan Hospital, Goyang, Korea.

出版信息

Obstet Gynecol Sci. 2019 Sep;62(5):344-351. doi: 10.5468/ogs.2019.62.5.344. Epub 2019 Jul 23.

Abstract

OBJECTIVE

The purpose of this study was to evaluate the effectiveness of scheduled ramosetron injections for controlling postoperative nausea and vomiting (PONV) after single-port access total laparoscopic hysterectomy (SPA-TLH).

METHODS

Ninety patients who underwent SPA-TLH at the Korean National Health Insurance Service Ilsan Hospital between June 2013 and July 2014 were enrolled in this prospective, randomized, double-blinded, placebo-controlled study. The patients were divided into 2 groups as follows: the ramosetron group (0.3 mg intravenously [IV]; n=45) and the placebo group (normal saline IV; n=45). Both groups received their respective injections 12 and 24 hours post surgery. The incidence and severity of PONV (numerical rating scale, 0-10), and the use of rescue antiemetics post surgery were evaluated.

RESULTS

Demographic and perioperative statistically significant differences were not observed between the 2 groups. The incidence of PONV in the ramosetron and placebo groups was 46.7% and 51.1%, respectively (=0.51). We found significant differences in the severity of PONV between the 24- to 48-hour postoperative periods in both groups (ramosetron group, =0.04 and placebo group, =0.03). The use of rescue antiemetics was significantly lower in the ramosetron group than in the placebo group (=0.02).

CONCLUSION

After general anesthesia, scheduled injections of ramosetron 12 and 24 hours after SPA-TLH reduced the severity of PONV and the use of rescue antiemetics. Administration of ramosetron can be considered not only immediately after SPA-TLH but also during the first 24-hour recovery period.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT02011659.

摘要

目的

本研究旨在评估单孔腹腔镜全子宫切除术(SPA-TLH)后定期注射雷莫司琼控制术后恶心呕吐(PONV)的有效性。

方法

选取2013年6月至2014年7月在韩国国民健康保险公团一山医院接受SPA-TLH的90例患者,纳入这项前瞻性、随机、双盲、安慰剂对照研究。患者分为两组:雷莫司琼组(静脉注射0.3mg;n = 45)和安慰剂组(静脉注射生理盐水;n = 45)。两组均在术后12小时和24小时接受各自的注射。评估PONV的发生率和严重程度(数字评分量表,0-10)以及术后抢救性止吐药的使用情况。

结果

两组之间在人口统计学和围手术期方面未观察到统计学上的显著差异。雷莫司琼组和安慰剂组PONV的发生率分别为46.7%和51.1%(P = 0.51)。我们发现两组在术后24至48小时期间PONV的严重程度存在显著差异(雷莫司琼组,P = 0.04;安慰剂组,P = 0.03)。雷莫司琼组抢救性止吐药的使用明显低于安慰剂组(P = 0.02)。

结论

全身麻醉后,SPA-TLH术后12小时和24小时定期注射雷莫司琼可降低PONV的严重程度并减少抢救性止吐药的使用。不仅在SPA-TLH后立即,而且在术后24小时的恢复期间都可考虑使用雷莫司琼。

试验注册

ClinicalTrials.gov标识符:NCT02011659。

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