一项前瞻性、随机、双盲、安慰剂对照研究，旨在评估咪达唑仑对行腹腔镜妇科手术的女性术后恶心和呕吐的止吐作用。

A prospective, randomized, double-blind, placebo-controlled study to assess the antiemetic effects of midazolam on postoperative nausea and vomiting in women undergoing laparoscopic gynecologic surgery.

机构信息

First Department of Anesthesiology, Toho University School of Medicine, Tokyo, Japan.

出版信息

Clin Ther. 2010 Aug;32(9):1633-7. doi: 10.1016/j.clinthera.2010.08.005.

DOI:10.1016/j.clinthera.2010.08.005

PMID:20974320

Abstract

BACKGROUND

Postoperative nausea and vomiting (PONV) are distressing and frequent adverse effects (AEs) in women undergoing laparoscopic gynecologic surgery. Midazolam has been reported to be effective for preventing PONV in adults undergoing middle ear surgery and children undergoing strabismus surgery or tonsillectomy.

OBJECTIVE

The aim of this study was to assess the antiemetic effects of midazolam on PONV in women undergoing laparoscopic gynecologic surgery.

METHODS

This prospective, randomized, double-blind, placebo-controlled study was conducted (January-December 2009) at the Department of Anesthesiology, Ushiku Aiwa General Hospital (Ibaraki, Japan). Nonpregnant Japanese women (aged 22-54 years) undergoing myomectomy, hysterectomy, salpingo-oophorectomy, or oophorectomy were randomized to receive 1 of 2 different midazolam doses (50 or 75 μg/kg IV) or placebo immediately after induction of anesthesia. Anesthesia was induced with propofol 2 mg/kg IV, and vecuronium 0.1 mg/kg IV was used to facilitate tracheal intubation. After tracheal intubation, anesthesia was maintained with sevoflurane 1.0% to 3.0% (inspired concentration) and air in oxygen. All episodes of PONV during the first 24 hours after anesthesia were assessed by an investigator 24 hours postoperatively; the investigator was blinded as to which treatment each patient had received. The patients were asked if nausea, vomiting, or retching had occurred. Details were recorded of any other AEs, as well as any spontaneous complaints.

RESULTS

A total of 90 nonpregnant Japanese women were enrolled (mean [SD] age, 35 [6] years; mean height, 159 [6] cm; mean weight, 53 [8] kg). Each study group comprised 30 patients and was comparable with regard to patient demographic characteristics and types of surgery. The rate of patients experiencing PONV during the first 24 hours after anesthesia with midazolam 50 μg/kg was 30% (P = 0.004 vs placebo) compared with 27% with midazolam 75 μg/kg (P = 0.002 vs placebo) and 67% with placebo. The difference in the incidence of PONV between patients receiving midazolam 75 μg/kg and those receiving midazolam 50 μg/kg was not statistically significant. No clinically important AEs due to the study drug were observed in any of the groups.

CONCLUSION

Midazolam 50 μg/kg was not significantly different from midazolam 75 μg/kg in the incidence of PONV, and both doses were associated with significantly less PONV compared with placebo during the first 24 hours after anesthesia in these Japanese women undergoing laparoscopic gynecologic surgery.

摘要

背景

术后恶心和呕吐（PONV）是行腹腔镜妇科手术的女性中令人痛苦且常见的不良反应（AE）。咪达唑仑已被报道对行中耳手术的成人和行斜视手术或扁桃体切除术的儿童预防 PONV 有效。

目的

本研究旨在评估咪达唑仑对行腹腔镜妇科手术的女性 PONV 的止吐作用。

方法

这是一项前瞻性、随机、双盲、安慰剂对照的研究（2009 年 1 月至 12 月），在日本宇都宫爱和综合医院麻醉科进行。非妊娠的日本女性（年龄 22-54 岁），行子宫肌瘤切除术、子宫切除术、输卵管卵巢切除术或卵巢切除术，随机接受以下 2 种咪达唑仑剂量（50 或 75 μg/kg IV）或安慰剂，均在麻醉诱导后即刻给予。麻醉诱导用丙泊酚 2 mg/kg IV，维库溴铵 0.1 mg/kg IV 辅助气管插管。气管插管后，使用七氟醚 1.0%至 3.0%（吸入浓度）和空气中的氧气维持麻醉。术后 24 小时由研究者评估麻醉后 24 小时内的所有 PONV 发作；研究者对每位患者接受的治疗不知情。研究者询问患者是否发生恶心、呕吐或干呕。记录任何其他 AE 以及任何自发的投诉的详细信息。

结果

共有 90 名非妊娠的日本女性入组（平均[标准差]年龄 35[6]岁；平均身高 159[6]cm；平均体重 53[8]kg）。每组 30 例患者，患者的人口统计学特征和手术类型相似。咪达唑仑 50 μg/kg 组麻醉后 24 小时内发生 PONV 的患者比例为 30%（P=0.004 比安慰剂），咪达唑仑 75 μg/kg 组为 27%（P=0.002 比安慰剂），安慰剂组为 67%。咪达唑仑 75 μg/kg 组和咪达唑仑 50 μg/kg 组 PONV 发生率的差异无统计学意义。在任何一组中，均未观察到因研究药物引起的具有临床意义的 AE。