Comparison of ondansetron with dexamethasone versus metoclopramide with dexamethasone for intraoperative oxytocin induced nausea and vomiting A randomised comparative study.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Incidence of intraoperative vomiting after oxytocin administration, from administration until the end of surgery, comparing ondansetron and dexamethasone versus metoclopramide and dexamethasone.
研究概览
简要总结
This prospective randomized comparative study is designed to evaluate the effectiveness of ondansetron with dexamethasone versus metoclopramide with dexamethasone in preventing intraoperative nausea and vomiting induced by oxytocin during elective caesarean section under spinal anaesthesia. Eligible parturients will be randomly allocated into two groups, Group O will receive ondansetron with dexamethasone, and Group M will receive metoclopramide with dexamethasone. The primary outcome is the incidence of intraoperative nausea and vomiting from the time of oxytocin administration until the end of surgery. Secondary outcomes include severity of nausea and vomiting, requirement for rescue antiemetics, and patient satisfaction. As all drugs are already approved and widely used, the study is classified as a Phase 4 trial, aiming to provide comparative efficacy data to guide optimal prophylaxis of oxytocin induced intraoperative nausea and vomiting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female patients under reproductive age group between 18 and 40 years.
- •Patient under ASA physical status I or II.
- •Patients undergoing elective cesaerean or gynaecological surgery under spinal anaesthesia.
- •Patients receiving exclusively oxytocin intraoperatively.
排除标准
- •Patients receiving Carboprost and Methergine.
- •Patients with history of motion sickness or postoperative nausea and vomiting.
- •Patients with prior antiemetic use within 24 hours.
- •Patients with known allergy to study drugs.
- •Patients with BMI more than 30 kg per m².
- •Procedures that get converted to general anaesthesia.
- •Patients with pre existing GI, neurological, or psychiatric disorders.
结局指标
主要结局
Incidence of intraoperative vomiting after oxytocin administration, from administration until the end of surgery, comparing ondansetron and dexamethasone versus metoclopramide and dexamethasone.
时间窗: 30 MINUTES
次要结局
- To assess the severity & frequency of vomiting episodes in both groups(To determine the need for rescue antiemetics in both treatment arms)
研究者
Dr Saundarya R
Shri Sathya Sai Medical College And Research Institute