A comparative study between Amisulpride Vs Ondansetron for prevention of post operative nausea and vomiting in laparoscopic surgeries .
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- To compare two drugs intraoperatively to see the effect of post op nausea and vomiting
研究概览
简要总结
Patient will be randomised into two groups, group A (Amisulpride 5mg) and group C (Ondansetron 8mg-conventional drug). Using computer generated simple randomised numbers. The group allocation will be done by PI sealed envelope type. Patient will be accepted for surgery after evaluation and optimisation. Informed consent will be taken for anaesthetic procedure and for the study. anaesthetists. Prior 20min before extubation, group Patients will be given Inj Amisulpride 5mg by intravenous over 1min and group C patients will be given Inj Ondansetron 8mg by intravenous over 1 min. Patient extubated and will be shifted to recovery room for observation. Monitor the patients for every 15mins for 1st hour, every 30mins for 2hours and thereafter every 6th hourly. Rescue anti emetic to be given postoperatively to any patient with nausea, from which they requested relief.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients undergoing general anesthesia with endotracheal intubation for laproscopic surgeries.
排除标准
- •1.Patients having allergies to the drug.
- •2.Transplant surgery or any surgery where postoperative emesis could pose a significant danger to the patient.
- •3.Had received Amisulpride for any indication in the 2 weeks before screening.
- •H/O vestibular disease or dizziness, were receiving regular anti-emetic therapy, still going on within 1 week before surgery, had a known prolactin-dependent tumor or Pheochromocytoma.
- •Pregnant or breastfeeding.
- •6.Clinically significant cardiac arrhythmia or congenital QT syndrome, had a h/o epilepsy or Parkinson’s disease or were being treated with levodopa.
结局指标
主要结局
To compare two drugs intraoperatively to see the effect of post op nausea and vomiting
时间窗: 15min | 30min | 45min | 60min | 1.30hour | 2.00hour | 2.30hour | 3.00hour | 6th hour | 12th hour | 18th hour | 24th hour
次要结局
- To compare between Amisulpride and Ondansetron for prevention of postoperative nausea and vomiting in laparoscopic surgery.(To determine any complications in study drugs Amisulpride and Ondansetron.)
研究者
Dr HARI GOVINDH A
RajaRajeswari Medical College and Hospital