Effectiveness of Preemptive Versus Preventive Antiemetic Treatment in Patients Undergoing Laparoscopic Cholecystectomy. A Randomized Double Blind Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 115
- 试验地点
- 2
- 主要终点
- PONV (postoperative nausea vomiting combined)
研究概览
简要总结
Patients aged between 20 and 70 years, ASA physical status I-III, and scheduled for laparoscopic cholecystectomy under general anaesthesia will be enrolled in the study.
Patients will be randomized to the preemptive group to receive an antiemetic regime 1h before the start of surgery or to the intraoperative group to receive the same antiemetic drugs in the same doses intraoperatively, 30 min before the end of surgery.
In the operating room standard monitoring and a standardized anesthetic technique will be implemented in all patients. Nausea, vomiting, retching and PONV (cumulative) will be recorded at PACU, at 4h, 8h and 24h postoperatively. Pain scores assessed by NRS (numerical rating scale) will be recorded at the same time points. Also, when patients received fluids and solid food by mouth will be recorded.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status I-III patients
- •Surgical procedure: scheduled for laparoscopic cholecystectomy
- •Type of anesthesia: general
排除标准
- •Antihistamines the last three days
- •Antiemetic drugs the last three days
- •Hiatus hernia
- •Gastrointestinal disease
- •Pregnancy
- •BMI > 35
- •parkinson
- •known allergy to the drugs of the protocol
研究组 & 干预措施
preemptive group
The preemptive group will receive the anti-emetic regimen i.v. (4 mg of ondansetron) 1h before the start of surgery. During surgery, 30 min before the end of operation, this group will receive i.v. 0.9% NaCl in equal volumes.The intervention consists of the different time points of antiemetic treatment, thus 1h before surgery vs intraopertively.
Intervention: Antiemetic treatment 1h before surgery
干预措施: Antiemetics perioperatively (Other)
intraoperative group
The preventive group will receive i.v. 0.9% NaCl 1h before surgery and ondansetron 4 mg 30 min before the end of surgery at equal volumes.
Intervention: Antiemetic treatment intraoperatively
干预措施: Antiemetics perioperatively (Other)
结局指标
主要结局
PONV (postoperative nausea vomiting combined)
时间窗: 24 hours
Incidence of combined nausea and vomiting postoperatively
次要结局
- postoperative vomiting frequency(24 hours)
- postoperative nausea frequency and intensity(24 hours)
- postoperative pain(24 hours)
- retching(24 hours)
- PONV (postoperative nausea vomiting combined)(24 hours)
研究者
Argyro Fassoulaki
Professor Emeritus
University of Athens