A Randomized Clinical Trial; Chewing Gum vs. Ondansetron as Rescue Treatment for PONV in Female Patients Undergoing Laparoscopic Surgery at a Single Centre in Lebanon
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Complete cessation of PONV with no recurrence and no rescue medication
研究概览
简要总结
The proposed randomized clinical trial aims to test and compare the efficacy of chewing gum vs. Intravenous antiemetic ondansetron as rescue treatment for post-operative nausea and vomiting (PONV) among Lebanese female patients undergoing laparoscopic surgery in the post-operative anesthesia care unit (PACU).
详细描述
Post-operative nausea and vomiting remains a significant complication following general anesthesia, particularly when volatile anesthetics are used. Previous studies, including a multicenter randomized trial conducted in Australia, have explored alternative treatment modalities for PONV. Chewing gum, a non-pharmacological intervention, has shown promise as a potential alternative or adjunct to conventional antiemetics like ondansetron. This study focuses on the Lebanese female population, aged 18 and above, who have undergone laparoscopic surgery under volatile anesthetic-based general anesthesia. This demographic is chosen based on established risk factors for PONV and may offer unique insights into efficacy within this subgroup.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Aged 18 and above,
- •Weight 40kg and above,
- •Who have undergone laparoscopic
- •Surgery under volatile anesthetic-based general anesthesia.
排除标准
- •Have history of motion sickness,
- •Maintained anesthesia during surgery using Propofol-pump
- •Were given antiemetics within 8 hours pre-surgery
- •Allergy to ondansetron
- •Planned mechanical ventilation post-operation
研究组 & 干预措施
Ondansetron
干预措施: Ondansetron (Zofran) (Drug)
Chewing Gum
干预措施: chewing gum (Other)
Ondansetron + Chewing Gum
干预措施: Ondansetron + Chewing gum (Combination Product)
结局指标
主要结局
Complete cessation of PONV with no recurrence and no rescue medication
时间窗: 2 hours
次要结局
- Patient satisfaction(post-operative period ( up to 3 hours))
- Quantity of rescue treatment modalities used(immediately after PONV start until complete resolution of symptoms)
研究者
Omar Rajab
Chairman of Anesthesia Department
Makassed General Hospital