Phenylepherine, ondensetron or a combination of both for prevention of intraoperative nausea and vomiting in patients undergoing lower segment caesarean section :a prospective ,double blind randomized control trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- Incidence of IONV
研究概览
简要总结
Intraoperative nausea and vomiting (IONV) is one of the commonest and most distressing complications in patients undergoing Lower Segment Caesarean Section under subarchnoid block((SAB).This is thought to be multi factorial in causation.Contributing factors include intraoperative hypotension,vagal hyperactivity,opioids use,utero tonic drugs and visceral pain.
Therefore any intervention aimed at addressing one or more of these variable will be expected to decrease or abolish intraoperative nausea and vomiting.
A****ims and****objectives
To determine whether combination of phenylepherine infusion with bolus ondensetron is more effective in prevention of intraoperative nausea vomiting,when compare to bolus ondensetron or phenylepherine infusion alone in patients undergoing Lower Segment Caesarean Section under subarchnoid block
Primary outcome measured:
1.Incidence of IONV (each episode = 1 incidence)
Secondary outcome
1. Nausea score
2. Total consumption of phenylepherine in intraoperative period
As the study period starts all consecutive parturient females posted for Caesarean Section will be enrolled for the study if they fulfil the inclusion criteria till 195 patient (65 in each group) will be completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 15.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •This study will be carried out in term pregnant female patients with singleton pregnancy, taken up for elective Caesarean Section under spinal anaesthesia for various indications like previous Caesarean Section, breech presentation, cephalopelvic disproportion, pregnancy following infertility treatment, cord around neck, non progression of labour.
排除标准
- •1.Patient refusal to participate in study 2.Emergency indication of Caesarean Section like antepartum haemorrhage, Placenta previa, abruptio placenta, fetal distress, obstructed labour, umbilical cord prolapse, preeclampsia, gestational diabetes, essential hypertension, more than two previous LSCS, history of PPH, multiple gestation.
- •3.Patients having contraindication for subarchnoid block.
- •4.Patient having associated systemic illness (hypo/hyperthyroidism, diabetic, neuromuscular disease ischemic/ valvular/ congenital heart disease, psychiatric, hematological disorder, SLE).
- •5.History of seizures, coma, neurological signs or symptoms (Eclampsia) 6.Any allergy to local anaesthetic or any drug.
结局指标
主要结局
Incidence of IONV
时间窗: intraoperative
次要结局
- Nausea score(Total consumption of phenylepherine in intraoperative period)