跳至主要内容
临床试验/CTRI/2022/05/042453
CTRI/2022/05/042453尚未招募不适用

A comparative study to evaluate the safety and efficacy of two different doses of oxytocin boluses in elective caesarean sections.

Department of Anaesthesia1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2022年5月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
104
试验地点
1
主要终点
â—To compare changes in HR and MAP (hemodynamic changes) that occur after administration of 1 and 3 units of iv oxytocin bolus.

研究概览

简要总结

Oxytocin is givento women during Caesarean section to decrease the blood loss and to preventpostpartum bleeding which is one of the major causes of maternal deaths all overthe world. Bolusdosing of oxytocin during C-section might lead to some hemodynamic variations such ashypotension and tachycardia, ST segment depression in ECG independent ofanesthesia and Cardiovascular collapse. Other adverse effects are waterretention, hyponatraemia, nausea and vomiting, feeling of warmth,palpitations, flushing, nasal congestion, xerostomia, metallic taste, headache,shivering and pruritus. 

Administeringthe appropriate amount of oxytocin maximizes its benefits and minimizes itsside effects. Thebolus causes detachment of placenta by constricting venous sinuses as well ashomeostasis of placental bed, in contrast the infusion sustains the contractionof uterusduring the surgical procedure and the postpartum period that follows. But repetitive doses of oxytocin to attainadequate uterine contractility in elective caesarean section needs to bere-evaluated, because they have significant adverseeffects when given as a rapid high-dose bolus.

Hencethe optimal dose of oxytocin in caesarean section is not clear. Thus,this study will be carried out to compare the efficacy & safety of twodifferent bolus doses of oxytocin in terms of adequate Uterine Tone, hemodynamiceffects and adverse effects during caesarean delivery.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant, Investigator and Outcome Assessor 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

  • ASA grade II, Elective LSCS under Spinal Anaesthesia, Singleton pregnancy.

排除标准

  • •Refusal of patient •Emergency LSCS •History of allergy to oxytocin •Placenta previa/accreta •Polyhydramnios •>2 Previous Caesarean sections •Multifetal Pregnancy •Contra-indications for Spinal Anaesthesia •Inadequate Spinal Anaesthesia or conversion to General Anaesthesia.

结局指标

主要结局

â—To compare changes in HR and MAP (hemodynamic changes) that occur after administration of 1 and 3 units of iv oxytocin bolus.

时间窗: Intra operative period after spinal anaesthesia

次要结局

  • â— To study the adequacy of utrerine contractions achieved by two different doses of oxytocin boluses.(â— Adverse effects that occur.)

研究者

申办方类型
Private medical college

研究点 (1)

Loading locations...

相似试验