瑞马唑仑与丙泊酚用于口腔颌面外科手术患者术后恶心呕吐的比较:一项前瞻性随机对照试验。

Comparison of postoperative nausea and vomiting between Remimazolam and Propofol in Patients undergoing oral and maxillofacial surgery: a prospective Randomized Controlled Trial.

机构信息

Department of Dental Anesthesia and Pain Medicine, School of Dentistry, Dental Research Institute, Pusan National University, Yangsan, Republic of Korea.

Dental and Life Science Institute, Pusan National University, Yangsan, Republic of Korea.

出版信息

BMC Anesthesiol. 2023 Apr 22;23(1):132. doi: 10.1186/s12871-023-02091-3.

Abstract

BACKGROUND

Remimazolam is a recently approved, ultra-short-acting benzodiazepine. However, few studies have investigated remimazolam in relation to postoperative nausea and vomiting (PONV). This study aimed to compare the effects of remimazolam and propofol on PONV in patients undergoing oral and maxillofacial surgery.

METHODS

Patients (n = 206) aged 19-65 years who were scheduled for oral and maxillofacial surgery were randomized into two groups, the remimazolam (R) and propofol group (P). In the R group (n = 94), remimazolam was used to induce anesthesia at 12 mg/kg/h and to maintain anesthesia at 1-2 mg/kg/h. In the P group (n = 95), anesthesia was induced and maintained with propofol (target effect-site concentration: 3-5 µg/ml). In both groups, remifentanil was administered at a target effect-site concentration of 2.5-4 ng/ml. The primary outcome was the overall incidence of PONV during the first 24 h after surgery. Secondary outcomes included the severity of nausea, use of rescue antiemetics, severity of postoperative pain, use of rescue analgesia, and quality of recovery.

RESULTS

The incidence of PONV during the first 24 h after surgery was 11.7% and 10.5% in the R group and P group, respectively, and there was no significant difference in the severity of nausea (P > 0.05). Ten patients in the R group and ten patients in the P group required rescue antiemetics during the first 24 h after surgery (P = 0.98). No inter-group differences were observed in terms of postoperative pain score, use of rescue analgesia, and quality of recovery (P > 0.05).

CONCLUSIONS

In this study, remimazolam did not increase the incidence and severity of PONV compared with propofol.

TRIAL REGISTRATION

KCT0006965, Clinical Research Information Service (CRIS), Republic of Korea. Registration date: 26/01/2022.

摘要

背景

雷米唑仑是一种最近批准的超短效苯二氮䓬类药物。然而,很少有研究探讨雷米唑仑与术后恶心和呕吐(PONV)的关系。本研究旨在比较雷米唑仑和丙泊酚对口腔颌面手术患者 PONV 的影响。

方法

年龄在 19-65 岁之间、拟行口腔颌面手术的患者(n=206)随机分为两组,雷米唑仑(R)组(n=94)和丙泊酚(P)组(n=95)。在 R 组中,以 12mg/kg/h 的速度诱导麻醉,以 1-2mg/kg/h 的速度维持麻醉。在 P 组中,以 3-5μg/ml 的目标效应室浓度诱导和维持麻醉。在两组中,均以 2.5-4ng/ml 的目标效应室浓度给予瑞芬太尼。主要结局是术后 24 小时内 PONV 的总体发生率。次要结局包括恶心的严重程度、止吐药的使用、术后疼痛的严重程度、解救镇痛的使用和恢复质量。

结果

术后 24 小时内,R 组和 P 组 PONV 的发生率分别为 11.7%和 10.5%,恶心严重程度无显著差异(P>0.05)。R 组有 10 例和 P 组有 10 例患者在术后 24 小时内需要使用解救止吐药(P=0.98)。两组术后疼痛评分、解救镇痛的使用和恢复质量无差异(P>0.05)。

结论

与丙泊酚相比,雷米唑仑并未增加 PONV 的发生率和严重程度。

试验注册

KCT0006965,韩国临床研究信息服务(CRIS)。注册日期:2022 年 1 月 26 日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/66ee/10122311/fbf0539e8ab0/12871_2023_2091_Fig1_HTML.jpg

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索