THE EFFECT OF THE COMBINATION OF DEXAMETHASONE WITH ONDANSETRON VERSUS DEXAMETHASONE WITH APREPITANT TO PREVENT POSTOPERATIVE NAUSEA AND VOMITING IN PATIENTS UNDERGOING LAPAROSCOPIC SURGERY
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Complete response
研究概览
简要总结
Postoperative nausea and vomiting (PONV) is a common problem after general anesthesia. The incidence can be as high as 80 percent in high-risk patients. Investigators designed this randomized, double- blind, single-center study to compare the efficacy of the combination of dexamethasone with ondansetron and dexamethasone with aprepitant undergoing laparoscopic surgery.
Seventy American Society of Anesthesiologist (ASA) physical class I-II, age 18-60 years patients scheduled for laparoscopic surgery were included in this study. Anesthesia was induced with propofol, fentanyl, and rocuronium, and maintained with sevoflurane in oxygen / air mixture in all patients. Remifentanil was continuously infused during surgery. Patients were randomly divided into two groups. Patients in the dexamethasone and aprepitant group (group DA, n=35) received 40 mg aprepitant orally 1 to 2 hours before induction of anesthesia and 2 ml saline intravenous (iv) within the last 30 minutes of surgery. Patients in the dexamethasone and ondansetron group (group DO, n=35) received an oral placebo identical to aprepitant 1 to 2 hours before induction of anesthesia and 4 mg ondansetron iv within the last 30 minutes of surgery. All patient received iv 8 mg dexamethasone after induction of anesthesia.
PONV and postoperative opioid consumption were assessed for 24 hours postoperatively. The blindly evaluated primary outcome was complete response. The secondary outcomes were incidence of nausea, retching or vomiting, the need of rescue antiemetic and opioid consumption within 24 hours after surgery. Statistical analyses were performed using Mann-Whitney U test, Chi-square test, and Fisher's Exact test. P<0.05 was considered statistically significant.Investigators hypothesized that the antiemetic efficacy of the aprepitant and dexamethasone combination is superior compared with ondansetron and dexamethasone combination following the laparoscopic 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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 Years to 60 Years
- •ASA (American Society of Anesthesiologist) physical status I or II
- •Patients undergoing laparoscopic gynecologic surgery or laparoscopic cholecystectomy
排除标准
- •Hypersensitivity or contraindication to the study medications,
- •Antiemetic drug or steroid use within 24 hours before anesthesia,
- •History of diabetes mellitus,
- •History of motion sickness or postoperative nausea and vomiting,
- •Pregnancy,
- •Breast feeding
研究组 & 干预措施
Group DA: Dexamethasone and aprepitant
Group DA: Dexamethasone: 8 mg (intravenous), Aprepitant: 40 mg (oral)
干预措施: Dexamethasone and aprepitant (Drug)
Group DO: Dexamethasone and ondansetron
Group DO: Dexamethasone: 8 mg (intravenous), Ondansetron: 4 mg (intravenous)
干预措施: Dexamethasone and ondansetron (Drug)
结局指标
主要结局
Complete response
时间窗: One year
The primary outcome is complete response: A complete response is defined as no postoperative nausea (VRS≤3), retching or vomiting and no need for rescue antiemetic.
次要结局
- Need of rescue antiemetic(One year)
- Nausea(One year)
- Vomiting(One year)
- Retching(One year)
研究者
Sevgi Bilgen
Assistant professor
Yeditepe University Hospital