Comparison of the Prophylactic Anti-emetic Efficacy of Gabapentin and Ramosetron in Patients Undergoing Laparoscopic Gynecological Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Incidence of postoperative nausea and vomiting
研究概览
简要总结
This study was designed to compare the effects of gabapentin and ramosetron on PONV in patients undergoing laparoscopic gynecologic surgery.
详细描述
Postoperative nausea and vomiting (PONV) in the postanesthesia care unit is a common occurrence after general anesthesia. And laparoscopic gynecological surgery is associated with a high incidence of PONV. Several antiemetic agents such as dopaminergic, histaminic and 5-HT3 antagonist (including ondansetron, ramosetron, granisetron) have been used to prevent PONV. Gabapentin, anti-convulsant, has been shown to decrease PONV, as well as chemotherapy induced nausea and vomiting in recent studies, although the exact mechanism against PONV is not known. The purpose of this study was to compare the efficacy of gabapentin and ramosetron in preventing PONV in patients undergoing laparoscopic gynecological surgery.
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
- Double (Investigator, Outcomes Assessor)
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
- 是
入选标准
- •Patients with ASA physical status 1 and 2 between 20 and 65 years undergoing laparoscopic gynecological surgery with patient-controlled analgesia for postoperative pain control.
排除标准
- •Pregnant women
- •Patients who took sedatives, antiemetics, hypnotics, analgesics, steroid, or gabapentin
- •Patients with neurological deficits
- •Patients with history of drug abuse and allergy of study drugs
研究组 & 干预措施
Gabapentin
oral gabapentin 300 mg 1 hours before induction of anesthesia
干预措施: Gabapentin (Drug)
ramosetron
ramosetron 0.3 mg iv at end of surgery
干预措施: Ramosetron (Drug)
Gabapentin and ramosetron
oral gabapentin 300 mg 1 hours before induction of anesthesia ramosetron 0.3 mg iv at end of surgery
干预措施: Gabapentin and Ramosetron (Drug)
结局指标
主要结局
Incidence of postoperative nausea and vomiting
时间窗: 48 hours postoperative
The incidence of postoperative nausea and vomiting will be assessed during 48 hours after surgery
次要结局
- sedation score(48 hours postoperative)
- patient's overall satisfaction score(48 hours postoperative)
- side effects(48 hours postoperative)
- pain score(48 hours postoperative)
- Severity of nausea(48 hours postoperative)