Effect of Remimazolam on Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- postoperative nausea and vomit within 24 hours after the end of operation
研究概览
简要总结
The present trial is to study the effect of low dose remimazolam on postoperative nausea and vomiting (PONV) in patients at risks of PONV (women, postoperative use of opioid, nonsmokers) undergoing laparoscopic cholecystectomy.
详细描述
Postoperative nausea and vomiting (PONV) is a common complication in patients undergoing general anesthesia. It is reported that PONV is observed in 50% of patients 24 hours after general anesthesia and upto 80% in high risk patients. The patients experiencing PONV may experience severe discomfort that it is important to prevent PONV. There are several prophylactic agents for PONV. 5 serotonin receptor antagonist(5-HT3 antagonist) is the most commonly used agent and other agents such as corticosteroid, neurokinin-1 receptor antagonist can also be used. Previous studies have reported the efficacy of benzodiazepine(midazolam) in a low targeting dose as a prophylactic agent of PONV. The efficacy of low dose remimazolam (short acting benzodiazepine) on PONV has not been evaluated.
According to Fourth consensus guideline for the management of postoperative nausea and vomiting (2020), three prophylactic anti-emetics are recommended for patients with three or more of the risk factors of PONV. As the patients included in our study have three or more of risk factors of PONV (women, postoperative use of opioid, nonsmokers), three prophylactic anti-emetics are recommended. Our center has routinely been using 5-HT3 receptor antagonist (ramosetron) and corticosteroid (dexamethasone) for women undergoing laparoscopic cholecystectomy. However, we still find many patients complaining nausea and vomiting after operation. Therefore, we are willing to investigate the low supplemental dose of remimazolam on the prophylaxis of PONV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women undergoing laparoscopic cholecystectomy under general anesthesia.
排除标准
- •moderate to severe liver dysfunction (total bilirubin ≧ 3.0 mg/dL / aspartate aminotransferase(AST) or alanine aminotransferase(ALT) ≧ 2.5 times more than normal range)
- •moderate to severe renal dysfunction (serum creatinine ≧ 2.0 mg/dL / end-stage renal disease undergoing hemodialysis)
- •tolerance to benzodiazepines
- •hypersensitivity to anesthetic drugs (Benzodiazepines, Propofol, Remifentanil, Fentanyl citrate, Rocuronium bromide, Flumazenil)
- •acute angle glaucoma
- •alcohol dependence
- •Galactose intolerance, Lactase deficiency, glucose-galactose malabsorption
- •pregnant, breast feeding women
- •BMI >35 kg/m2
- •uncontrolled diabetes mellitus
研究组 & 干预措施
Remimazolam group
Remimazolam is started during induction of anesthesia at the rate of 0.3 mg/kg/hr and stopped 20 minutes before end of operation.
干预措施: Remimazolam (Drug)
Control group
0.9% normal saline is started during induction of anesthesia at the rate of 0.3 ml/kg/hr and stopped 20 minutes before end of operation.
干预措施: Control (Drug)
结局指标
主要结局
postoperative nausea and vomit within 24 hours after the end of operation
时间窗: Upto 24 hours after surgery
Nausea is evaluated using 11-point verbal numeric rating scale (VNRS -none:0, mild: 1-3, moderate:4-6, severe 7-10). Vomiting is checked when the patient has vomited or has retching symptom.
次要结局
- pain 24 hours after the end of the operation(Upto 24 hours after surgery)
- quality of recovery (QoR-15) 24 hours after the end of the operation(Upto 24 hours after surgery)
研究者
In-Jung Jun
associate professor
Inje University