The Effect on Anxiolytics With Type of Antiemetic Agents on Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- percentage of patients receiving ramosetron or palonosetron in each groups
研究概览
简要总结
Nausea and vomiting after surgery are one of the complications that occur after general anesthesia, and the frequency is reported to range from 10% to 80% in the high-risk group. Several studies have introduced drugs and methods to prevent nausea and vomiting after surgery. Among them, midazolam administered before surgery is known to have anti-anxiolytic and sedative effects on the prevention of nausea and vomiting after surgery. It has also been reported to increase its effectiveness when administered with other antiemetic agents.
The purpose of this study is to compare the effects of administration of combination with midazolam and different antiemetic agents on the prevention of postoperative nausea and vomiting in high-risk patients.
详细描述
This prospective study evaluates female, nonsmoking patients undergoing laparoscopic cholecystectomy. The patients are divided into those with and without postoperative nausea and vomiting. The purpose of this study is to compare and observe the effect of administration of midazolam and two different antiemetics on prevention of postoperative nausea and vomiting.
0.05mg/kg of midazolam is administered intravenously 10 minutes before surgery as a pretreatment. 0.3mg ramosetron is administered intravenously right before the end of surgery and 0.075mg palonosetron is administered intravenously immediately after induction of anesthesia. The incidence of PONV, severity of nausea, use of rescue antiemetics, and pain severity was evaluated at 2 hours, 24hours, and 48 hours after surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •20-65 years old with American Society of Anesthesiologists (ASA) physical status 1-2 and scheduled for laparoscopic cholecystectomy.
排除标准
- •pregnant or breast feeding patients
- •patients with history of chronic opioid abuse
- •hypersensitivity to 5-HT3 receptor antagonists or analgesics
- •those who were antiemetic or opioid treatment within 24 hours prior to surgery
结局指标
主要结局
percentage of patients receiving ramosetron or palonosetron in each groups
时间窗: 48 hours after surgery
percentage of patients receiving ramosetron or palonosetron
severity of postoperative nausea in PONV group
时间窗: 48 hours after surgery
0 = none, 1 = mild, 2 = moderate, 3 = severe
次要结局
- postoperative pain(48 hours after surgery)
研究者
Jung A
Assistant professor
Daegu Catholic University Medical Center