The Effect of Ondansetron on the Efficacy of Tramadol
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Interaction
研究概览
简要总结
In the postoperative period; pain, nausea, and vomiting are undesirable side effects that reduce the patient's comfort and may lead to various complications. Ondansetron is frequently used as an antiemetic and tramadol hydrochloride is used for postoperative analgesia in laparoscopic cholecystectomy. However, some studies have reported that there is a drug interaction between these two drugs and they reduce each other's effects, thus requiring more analgesics in the postoperative period.
The aim of this study is; To evaluate whether ondansetron reduces the analgesic efficacy of tramadol hydrochloride in laparoscopic cholecystectomies.
详细描述
During the operation, 4 mg iv ondansetron (2mL) will be administered to the ondansetron group and 2mL iv 09% saline will be administered to the placebo group. The patients' heart rate, blood pressure, oxygen saturation, sedation score (with Ramsey Seading Score), amount of pain (with NRS), degree of nausea (with NRS), whether there is vomiting, whether analgesic or antiemetic treatment is required, and the amount of tramadol use will be recorded at 1, 2, 4, 8, 12 and 24 hours in the postoperative period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 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
- 是
入选标准
- •60 patients over the age of 18, ASA I-II, undergoing laparoscopic cholecystectomy
排除标准
- •Patients under 18 years of age
- •Patients with known allergies to the drugs to be used
- •Pregnant and breastfeeding mothers
- •Patients who received antiemetic or cortisone within 24 hours before surgery
- •Patients with mental illness or epilepsy
- •Patients with alcohol or substance abuse
研究组 & 干预措施
Ondansetron
Participants will receive Kemoset 4 mg iv intraoperatively
干预措施: Ondansetron 4 MG (Kemoset 4mg) (Drug)
Salin solution
Participants will receive Salin solution 2ml (iv) intraoperatively
干预措施: Salin solution (Other)
结局指标
主要结局
Interaction
时间窗: 24 hours
The hypothesis of this study is that if ondanstron is given together with tramadol peroperatively, tramadol consumption is increase postoperatively due to tramadol ondansetron interaction. The primary outcome measure is consumption of tramadol postoperatively for 24 hours.
次要结局
未报告次要终点
研究者
Sevgi Bilgen
Associate professor
Acibadem University