Prophylaxy of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Postoperative Nausea or vomiting M12
研究概览
简要总结
Postoperative nausea and vomiting (PONV) is one of the most commonly reported adverse effects of anesthesia. The general incidence of vomiting is approximately 30%, nausea at 50% and the PONV rate can go up to 80% in high-risk patients without prophylaxis. Prevention of these episodes in high-risk patients improves satisfaction and well-being rates. Therefore, it becomes important the adequate control of PONV, aiming at the satisfaction of the patient with the procedure, lower costs for the health system as well as reduction of complications in the postoperative period. This study aims to evaluate the association of gabapentin or pregabalin with dexamethasone in reducing the incidence of PONV in high-risk patients undergoing laparoscopic surgeries in the first 48 hours postoperatively as well as to assess side effects.
详细描述
The study included 60 patients at high risk for PONV (Apfel-score 0, I, II, III and IV) scheduled for elective laparoscopic surgeries at the Central Surgical Center of Irmandade da Santa Casa de Misericórdia in São Paulo. Inclusion criteria will be ASA I or II of either sex, in the age range of 18 to 70 years. In this study, the recruited patients will be allocated randomly into three groups. The group A will receive oral 600 mg gabapentin 2 h before surgery. The group B will receive oral 150 mg pregabalin 2 h before surgery. The Group C will receive oral placebo 2 h before surgery and ondansetron 8mg intravenous at the end of the surgery. This study is "double-blind", in which neither the doctor nor the patient knows what medicine is being given.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing laparoscopic procedures
- •Apfel Score 0, I, II, III and IV
- •ASA I / II
排除标准
- •Patients with surgery converted to open before thirty minutes of surgery
- •Patients who were exposed previously to gabapentin or pregabalin Patients who have allergy to any medicine used in the study
- •Patient who have to any cognitive impairment
- •Illiterate patients
- •Patients who refuse to participate in the study
研究组 & 干预措施
Active Comparator: Group B - pregabalin
The patient will receive oral pregabalin 150 mg 2 h before surgery
干预措施: Group B - pregabalin (Drug)
Active Comparator: Group A - gabapentin
The patient will receive oral 600 mg gabapentin 2 h before surgery
干预措施: Group A - gabapentin 600 mg (Drug)
Placebo Comparator: Group C - placebo
The patient will receive oral placebo 2 h before surgery and ondansetron 8mg intravenous at the end of the surgery
干预措施: Group C - placebo (Drug)
结局指标
主要结局
Postoperative Nausea or vomiting M12
时间窗: 12 hours
The occurrence of postoperative nausea or vomiting, reported by the patient or witnessed by a healthcare provider during the first 12 hours after surgery
Postoperative Nausea or vomiting M48
时间窗: 48 hours
The occurrence of postoperative nausea or vomiting, reported by the patient or witnessed by a healthcare provider during the first 48 hours after surgery
Postoperative Nausea or vomiting M24
时间窗: 24 hours
The occurrence of postoperative nausea or vomiting, reported by the patient or witnessed by a healthcare provider during the first 24 hours after surgery
Postoperative Nausea or vomiting M0
时间窗: 1 hours
The occurrence of postoperative nausea or vomiting, in the recovery room, during the first hour after surgery
次要结局
- Patient demographic data(Before surgery)
- Duration of postoperative anesthesia stay(First hours after surgery)
- Amount of medication(During the first 30 days after surgery)
- Postoperative complications(During the first 30 days after surgery)
- Degree of patient satisfaction(Before discharge)
- The length of stay in hospital(From end of surgery until hospital discharge or 30 days after surgery)
- Time to request the first medication for nausea and vomiting(First hour after surgery)
- Surgical Duration(First hour after surgery)
研究者
Lígia Andrade da Silva Telles mathias
Doctor
Faculdade de Ciências Médicas da Santa Casa de São Paulo