Preoperative Ginger for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Cholecystectomy: A Double-Blind Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Incidence of postoperative nausea and vomiting (PONV) within 2 hours post-surgery
研究概览
简要总结
This study aims to evaluate whether preoperative oral administration of ginger (800 mg, given 2 hours before surgery) reduces the incidence and severity of postoperative nausea and vomiting (PONV) within the first 24 hours after 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
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Scheduled for elective laparoscopic cholecystectomy under general anesthesia.
- •American Society of Anesthesiologists (ASA) physical status I-III.
- •Able to understand the study procedures and provide written informed consent.
排除标准
- •Known allergy or hypersensitivity to ginger
- •Documented history of bleeding disorders or current treatment with anticoagulant agents
- •History of severe postoperative nausea and vomiting or an Apfel score of 4
- •Administration of antiemetic drugs or corticosteroids during the preoperative period
- •Pregnancy or breastfeeding
- •Active gastrointestinal or liver disease
研究组 & 干预措施
Ginger group
Patients will receive 800 mg of oral ginger 2 hours before laparoscopic cholecystectomy
干预措施: Ginger (Drug)
Placebo group
Patients will receive an oral placebo capsule identical in appearance to ginger, administered 2 hours before laparoscopic cholecystectomy
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of postoperative nausea and vomiting (PONV) within 2 hours post-surgery
时间窗: 2 hours after surgery.
Occurrence of at least one episode of nausea or vomiting within the first 2 hours after surgery.
次要结局
- Recurrence of PONV beyond 2 hours postoperatively(From 2 hours to 24 hours after surgery.)
- Incidence of postoperative nausea and vomiting (PONV) within 24 hours post-surgery(24 hours after surgery.)
- Total number of vomiting episodes(Within 24 hours post-surgery.)
- Use of rescue antiemetics(24 hours postoperatively)
- Incidence of ginger-related adverse events(Within 24 hours after surgery)
研究者
Ben Taleb Ibtissem
Assistant Professor in Anesthesiology and Intensive Care
University Tunis El Manar