Efficacy of Lingual Ondansetron in Reduction of Spinal Anesthesia-induced Hypotension In Cesarean Section; a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- ephidrine consumption
研究概览
简要总结
The goal of this clinical trial is to learn if drug ondansetron, used in lingual form, lowers the incidence of spinal anesthesia-induced hypotension in cesarean sections. It will also learn about the safety of drug ondansetron. The main questions it aims to answer are
Does the drug ondansetron, used in lingual form, lower the incidence of spinal anesthesia-induced hypotension in cesarean sections? What medical problems do participants have when taking the drug ondansetron? Researchers will compare drug ondansetron to a placebo (a look-alike substance that contains no drug) to see if drug ondansetron works to reduce the incidence of spinal anesthesia-induced hypotension in cesarean sections
Participants will:
Take drug ondansetron or a placebo before induction of spinal anesthesia
详细描述
Spinal anesthesia, which is extensively used in a variety of surgical operations, frequently causes hypotension due to sympathetic nerve blocking. This reduction in blood pressure might have negative consequences, especially in people with cardiovascular comorbidities. Ondansetron, a selective serotonin 5-HT3 receptor antagonist, is well known for its antiemetic effects. However, its ability to reduce hypotension during spinal anesthesia has sparked great interest in recent years. Thus, it regulates cardiovascular function, vasodilation, and vascular tone and helps to maintain a more steady hemodynamic profile during spinal anesthesia.
A growing amount of evidence supports the use of ondansetron as a preventive strategy against spinal anesthesia-induced hypotension. This technique not only improves patient safety but also minimizes intraoperative problems. As research advances, using ondansetron in anesthetic protocols may become commonplace, reflecting its numerous benefits in the perioperative situation.
Objective: To investigate the efficacy of the lingual film form of ondansetron after use in parturients undergoing spinal anesthesia during cesarean delivery to reduce total ephedrine consumption and spinal-induced hypotension.
Methodology: Following the administrative ethical committee approval and informed patient consent obtained from 112 patients undergoing cesarean delivery in Suez Canal University Hospital, they will be randomly assigned to one of the two groups using a computer software program.
Group A (56 patients) will be administered 8 mg of the lingual film form of ondansetron, given 15 minutes before spinal anesthesia.
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: 18- 40 years old parturients.
- •Height: 150 to 180 cm
- •Patients are ASA II (American Society of Anesthesiologists physical status grade II) = (pregnant and patients with mild systemic disease and no functional limitations).
- •Patients scheduled for elective cesarean section in Suez Canal University Hospitals.
排除标准
- •Patients' refused to participate in the study.
- •Contraindications of spinal anesthesia (patients with marked deformities or infections at the site of spinal injection, and coagulopathy).
- •Known allergy to bupivacaine or ondansetron.
研究组 & 干预措施
ondansetron
8 mg of the lingual film form of ondansetron will be given 15 minutes before spinal anesthesia
干预措施: ondansetron lingual film (Drug)
placebo
a placebo lingual film form will be given 15 minutes before spinal anesthesia
干预措施: Placebo (Drug)
结局指标
主要结局
ephidrine consumption
时间窗: From the moment the surgery starts until it is finished, or after 90 minutes has passed, whichever is longer
To evaluate the impact of lingual ondansetron on parturients having cesarean sections' overall intraoperative ephedrine consumption
次要结局
未报告次要终点
研究者
Abdelrhman Alshawadfy
professor of anaesthesia
Suez Canal University