The Effect of Peroperative Restrictive and Liberal Fluid Regimens on Postoperative Nausea-vomiting and Quality of Recovery in Laparoscopic Cholecystectomy: a Prospective Randomized Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Incidence of postoperative nausea-vomiting
研究概览
简要总结
Patients planned for laparoscopic cholecystectomy will be included in this study. The effects of liberal and restrictive fluid regimens given peroperatively to patients undergoing laparoscopic cholecystectomy will be compared on postoperative nausea and vomiting. The aim of this study is to investigate which regimen is more effective on postoperative nausea and vomiting in laparoscopic cholecystectomy.
详细描述
Postoperative nausea and vomiting (PONV) is a common and disturbing side effect of anesthesia and surgery, and while its incidence in all surgical procedures varies between 20-77% if antiemetic prophylaxis is not applied, this rate is even higher in people prone to vomiting, such as cyclic vomiting syndrome . Its incidence varies between 53 - 72%, especially in patients undergoing laparoscopic cholecystectomy surgery, if antiemetic prophylaxis is not administered.
Since most existing antiemetics are expensive and cannot completely eliminate PONV, pharmacological PONV prophylaxis may not be cost-effective. For this reason, the incidence of PONV can be reduced by increasing the amount of inexpensive fluid used during surgery instead of prophylactic drug treatment. There are several studies investigating the effect of different perioperative fluid administration schemes on PONV in the adult population, especially in patients undergoing laparoscopic cholecystectomy or gynecological surgery, with variable results.
Based on this point, the inestigetors wanted to examine the effect of perioperative liberal and restrictive fluid treatments on PONV in patients who underwent laparoscopic cholecystectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
patients, care providers, and outcome assessors will be blinded.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients planned for laparoscopic cholecystectomy
- •Patients aged 18-70
排除标准
- •Congestive heart failure.
- •Diabetes.
- •Epilepsy.
- •Heart valve disease.
- •They are pregnant.
- •Chronic liver disease.
- •Chronic kidney disease. Chronic gastrointestinal tract disease. Those who used antiemetic drugs within 24 hours before surgery. Those who developed intraoperative hypertension. Those who develop excessive blood loss. Patients whose surgery procedure takes more than 2 hours.
研究组 & 干预措施
Liberal Fluid Group
Patients in this group will be administered 20 mL/kg/h ringer lactate intravenously peroperatively.
干预措施: Liberal Fluid Grubu (Other)
Restrictive Fluid Group
Patients in this group will be administered 4 mL/kg/h ringer lactate intravenously peroperatively.
干预措施: Restrictive Fluid Group (Other)
结局指标
主要结局
Incidence of postoperative nausea-vomiting
时间窗: Postoperative 24 hours
Incidence of nausea and vomiting within 24 hours after surgery. The presence of at least one episode of nausea, retching and vomiting in the first 24 hours postoperatively will be considered a positive result.
Quality of recovery
时间窗: Postoperative 24 hours
Quality of recovery will be evaluated at the 24th hour using the QoR-15 scale. It is a scale consisting of 15 questions and scoring from 0 to 10 for each question. 0 represents the worst and 150 represents the best recovery quality.
次要结局
- Time to first antiemetic request(Postoperative 24 hours)
- Time to request first oral drink(Postoperative 24 hours)
- Total amount of analgesic(Postoperative 24 hours)
- First mobilization time(Postoperative 24 hours)
研究者
muhammet korkusuz
Principal Investigator, MD
Karaman Training and Research Hospital