Comparison of intravenous amisulpride with promethazine for the treatment of postoperative nausea and vomiting in female patients after general anaesthesia: A double-blind randomised study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Proportion of patients with complete response to treatment dose of amisulpride or promethazine. The complete response will be defined as :cessation of nausea , retching or vomiting with no recurrence and no rescue medications in the 4 hrs after administration, excluding any emesis events in first 15 minutes
研究概览
简要总结
The title of my thesis is comparison of intravenous amisulpride with promethazine for the treatment of postoperative nausea and vomiting in female patients after general anaesthesia. It is a randomized double-blind randomized study . Sample size is 224 . Patients who will be experiencing nausea vomiting even after giving intraoperatively ondansreron 4 mg will be divided into two groups randomly by sealed envelopes. One group will be given intravenous amisulpride and another group will be given intravenous promethazine. The response of both drugs in terms of episodes of emesis and nausea using VDS score will be noted. Any side effects of the drugs will be recorded too
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 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female patients undergoing elective surgical procedures under general anaesthesia who are ASA 1,2 or 3.
排除标准
- •Pregnant and lactating mothers Patients undergoing total intravenous anaesthesia Significant ongoing vestibular disease or dizziness Known prolactin dependant tumours or pheochromocytoma Those with clinically signicant cardiac arrhythmias or long QT syndrome Patients with substance abuse History of psychiatric illness epilepsy or Parkinson’s disease Documented allergy to amisulpride or any other dopamine antagonists drugs.
结局指标
主要结局
Proportion of patients with complete response to treatment dose of amisulpride or promethazine. The complete response will be defined as :cessation of nausea , retching or vomiting with no recurrence and no rescue medications in the 4 hrs after administration, excluding any emesis events in first 15 minutes
时间窗: 4 hrs after shifting the patient to PACU
次要结局
- Mean verbal descriptive scale (VDS) score for nausea(At 5 minute interval upto 30 minutes and at 2,6,12,24 hrs after administration of study drugs)
- Number of episodes of emesis after administration of study drugs
- Mean time to achieve complete response
- Total no. Of doses of rescue antiemetics after surgery(At 24 hrs)
- Any side effects of study drugs
- Mean postoperative quality recovery -15 score(At 24 hrs after surgery)
研究者
Dr Bharti Goel
Maulana Azad Medical college