跳至主要内容
临床试验/CTRI/2020/12/030039
CTRI/2020/12/030039招募中2 期

TO COMPARE THE EFFECT OF INFUSION DOSES OF INTRAVENOUS PHENYLEPHRINE, NOREPINEPHRINE AND MEPHENTERMINE FOR MAINTENANCE OF BLOOD PRESSURE DURING SPINAL ANAESTHESIA IN CAESAREAN SECTION AND THEIR EFFECTS ON NEONATE.

kalinga institute of medical sciences1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2021年1月1日最近更新:

试验速览

阶段
2 期
状态
招募中
入组人数
240
试验地点
1
主要终点
•To compare the effect of prophylactic infusion of intravenous phenylephrine, nor epinephrine and mephentermine for maintenance of blood pressure in patients undergoing elective caesarean section under spinal anesthesia .

研究概览

简要总结

The technique of choice foranaesthesia in caesarean section, is subarachnoid block. However, thistechnique is known to cause hypotension, i.e., fall in blood pressure more than20% from the baseline. Such fall in blood pressure can have deleterious effectson both the mother and the baby in utero. The incidence of maternal hypotensioncan be as high as 70- 85% if pharmacological prophylaxis isn’t used. Whenmaternal hypotension is recognized and treated promptly, the maternal and fetalmorbidity is decreased significantly. Hence, in our study, we are comparingthree vasopressor agents, viz., Phenylephrine, Noradrenaline, andMephentermine, so as to determine the best pharmacological agent to preventmaternal hypotension in parturients undergoing caesarean section under spinalanaesthesia. The patients who match our inclusion and exclusion criteria, andthose who give a valid written informed consent, shall be divided into threegroups, each receiving one of the three vasopressor agents if they develophypotension following spinal anaesthesia. We shall be observing the incidenceand magnitude of maternal hypotension following spinal anaesthesia. We shallalso be documenting the incidence of, as well as the magnitude of decrease infall in BP , the amount of drug dosages of each vasopressor agent required forthe same, neonatal APGAR scores at 1 minute and 5 minutes, and the incidence ofmaternal post-operative nausea and vomiting.

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
21.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • 1.Age 21-40 years 2.ASA II 3.Singleton term pregnancy 4.Elective caesarean section 5.Parturient with no co-morbidity.

排除标准

  • 1.Pre-existing pregnancy-induced hypertension 2.Cardiovascular disease 3.Hepato-renal disease 4.Use of cardiac medication or medication for blood pressure control 5.Gestational diabetes mellitus requiring insulin 6.Suspicion of abnormal placentation 7.Allergy to study drugs 8.Intraoperative use of uterotonic other than oxytocin 9.Known fetal abnormality 10.Contraindication to subarachnoid block.

结局指标

主要结局

•To compare the effect of prophylactic infusion of intravenous phenylephrine, nor epinephrine and mephentermine for maintenance of blood pressure in patients undergoing elective caesarean section under spinal anesthesia .

时间窗: Blood pressure and heart rate recorded every 2 minutes until delivery.

次要结局

  • Incidence of bradycardia,hypertension,hypotension.(-Total doses of rescue drug required.)

研究者

申办方类型
Private medical college

研究点 (1)

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