Observation on the Efficacy of Three Antiemetics in Preventing Nausea and Vomiting Caused by Intravenous Tramadol Injection and Postoperative Nausea and Vomiting
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- NRS score of nausea and vomiting
研究概览
简要总结
To explore the effect of commonly used antiemetic drugs on reducing nausea and vomiting caused by intravenous tramadol injection, so as to reduce the incidence of nausea and vomiting in clinical use of tramadol and provide guidance for the clinical use of tramadol injection
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists classification I-II
- •18.5≤BMI≤28
- •Patients who receiving breast and thyroid surgery and requiring general anesthesia and receive PCIA
- •Voluntarily and be able to understand and sign the informed consent form
排除标准
- •Long-term use of analgesics, psychotropic drugs (including opioids, NSAIDS, antidepressants) history
- •History of allergy to opioids
- •Patients with a history or family history of epilepsy that has not been controlled by treatment
- •Sedatives and antidepressants were used 24 hours before surgery
- •Failure to cooperate with the study for any reason or in the opinion of the investigator
研究组 & 干预措施
tropisetron
Troisetron was given 30 minutes in advance, and then tramadol 1.5mg/kg was intravenously injected with a micropump at a constant speed.
干预措施: tropisetron (Drug)
metoclopramide
Metoclopramide was given 30 minutes in advance, and then tramadol 1.5mg/kg was injected intravenously with a micropump at a constant speed.
干预措施: metoclopramide (Drug)
dexamethasone
Dexamethasone was given 30 minutes in advance, and then tramadol 1.5mg/kg was injected intravenously with a micropump at a constant speed.
干预措施: dexamethasone (Drug)
normal saline
Equal dose of normal saline was given 30 minutes in advance, and then tramadol 1.5mg/kg was given intravenously to ensure constant speed.
干预措施: normal saline (Other)
结局指标
主要结局
NRS score of nausea and vomiting
时间窗: From before administration to 10min after administration
NRS score of nausea and vomiting was assessed by numerical rating scale (0-10, 0 representing no nausea and 10 the worst nausea imaginable)
次要结局
- Incidence of extra treatment for postoperative nausea and vomiting(From end of operation to 24 hours after operation)
- Incidence of postoperative nausea and vomiting(From end of operation to 24 hours after operation)
- NRS score of postoperative nausea and vomiting(From end of operation to 24 hours after operation)