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临床试验/NCT03693638
NCT03693638已完成不适用

A Comparative Study of Fractionated Vs Single Dose Injection for Spinal Anesthesia During Caesarean Section in Patients With Pregnancy-Induced Hypertension

Indonesia University1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2018年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
1
主要终点
Change of mean arterial pressure (MAP)

研究概览

简要总结

The aim of this study was to compare haemodynamic changes, total dose of ephedrin requirement, and level of sensory blockade between fractionated dose and single dose spinal anesthesia injection in obstetric patients with pregnancy-induced hypertension who underwent Caesarean section

详细描述

Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study and randomized into two groups; single dose (SD) and fractionated dose (FD). All subjects will receive spinal anesthesia with 2,5 ml of 10 mg bupivacaine hyperbaric 0,5% and fentanyl 25 mcg. After IV cannulas (18 - 20 G) were properly placed, premedication with intravenous (IV) ranitidine 50 mg and metoclopramide 10 mg were given. Additional IV access was added if MgSO4 must been continuously administered intravenously perioperatively. Standard monitor device were placed after patients had been transferred to operating room. Additional premedication such as intravenous midazolam 0.02 mg/BW or fentanyl 1 mcg/BW were given if the patients were anxious or in pain. Baseline haemodynamic measurement was done two minutes after premedication. Spinal anesthesia was performed while patients in sitting position at L3-4 or L4-5 level with median or paramedian approach, with total dose 2,5 ml of 10 mg bupivacaine hyperbaric 0,5% and fentanyl 25 mcg. After skin wheal of lidocaine at the intended spinous interspace were placed, spinal needle (SpinocanR, B Braun, 27 G) were inserted and advanced until subarachnoid space were reached. In group FD, 1,5 ml of total dose followed by 1 ml remaining dose after 90 s interval were given. In SD group, 2,5 ml total dose were given with 0.2 ml/second rate, and subjects were asked to remain sitted for 90 seconds. If there were more than three injection attempts, the patients were excluded from the study. Co-loading 5 - 10 ml/kg ringer lactate in 20 minutes were given for all subjects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • with hypertension in pregnancy (gestational hypertension or preeclampsia)
  • ASA II-III
  • aged 18 - 40 years
  • BMI 18.5 - 35 kg/m2
  • singleton pregnancy
  • would undergo spinal anesthesia for emergency or semi-emergency caesarean section

排除标准

  • chronic hypertension
  • eclampsia
  • pulmonary edema
  • cerebrovascular diseases
  • type-2 diabetes mellitus and gestational diabetes
  • placental abruption/previa/accreta
  • umbilical cord prolapse
  • gestational age <34 weeks
  • estimated fetal weight <=2.300 gram and >=4.000 gram
  • polyhydramnios
  • fetal distress

研究组 & 干预措施

Single dose (SD)

Active Comparator

2,5 ml total anesthetic drug dose (Bupivacaine-fentanyl) were given with 0.2 ml/second rate, and subjects were asked to remain sitted for 90 seconds

干预措施: Bupivacaine-fentanyl (Drug)

Fractionated dose (FD)

Active Comparator

1,5 ml of total anesthetic drug dose (Bupivacaine-fentanyl) followed by 1 ml remaining dose after 90 s interval were given

干预措施: Bupivacaine-fentanyl (Drug)

结局指标

主要结局

Change of mean arterial pressure (MAP)

时间窗: 15 minutes

drop of blood pressure more than 20% of baseline value, and were treated with ephedrine 5 - 10 mg which could be repeated if necessary

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alfan Mahdi Nugroho

Principal Investigator

Indonesia University

研究点 (1)

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