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临床试验/NCT01572805
NCT01572805已完成1 期

Evaluation of Melatonin's Effect on Pain and Blood Loss After Cesarean Section

Qazvin University Of Medical Sciences1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2012年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
120
试验地点
1
主要终点
Time to first requirement of analgesic supplement

研究概览

简要总结

The purpose of this study is to assess the effect of melatonin on pain and amount of blood loss after cesarean delivery one hundred twenty women with singleton term pregnancy undergoing elective or emergency lower segment cesarean section under spinal anesthesia were included in this study. The patients were randomly allocated to one of three groups of 40 each to receive sublingual 3 mg melatonin or 6 mg melatonin or placebo before spinal of anesthesia . In all patients 20 IU syntocinon which dissolved in 0.5liter of lactated Ringer's solution) at the rate of 500 ml over a 15 minutes period, immediately after delivery of the neonate was infused . Time to first requirement of analgesic supplement, Hemodynamic variables,will be recorded.Patients were instructed preoperatively in the use of the verbal rating scale (VRS) from 0 to 10 (0no pain, 10maximum imaginable pain) for pain assessment. If the VRS exceeded four and the patient requested a supplement analgesic, diclofenac Na supp 100 mg was to be given for post-operative pain relief as needed . For breakthrough pain(VRS >4) if time of administration of diclofenac Na less than 8h,Pethidine 25 mg IV was given. For determination of blood loss ,change in hemoglobin levels, need for additional oxytocics and ,the volume of blood in the suction bottle was measured, blood soaked sponges. Hemoglobin values were determined both before surgery and 12 h following surgery

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 42 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • pregnant women at term (37-40 wks) gestation scheduled for either elective or emergency lower segment cesarean section

排除标准

  • women with any risk factor associated with an increased risk of postpartum hemorrhage were excluded i.e. multiple gestation, antepartum hemorrhage,poly-hydramnios, two or more previous cesarean sections and/or a history of previous rupture uterus
  • current or previous history of significant disease including heart disease, liver, renal disorders ,anemia (Hb8 g%)or known coagulopathy

研究组 & 干预措施

melatonin 3mg

Active Comparator

干预措施: melatonin 3mg (Drug)

melatonin 6mg

Active Comparator

干预措施: melatonin 6mg (Drug)

placebo

Placebo Comparator

干预措施: placebo (Drug)

结局指标

主要结局

Time to first requirement of analgesic supplement

时间窗: Time to first requirement of analgesic supplement within 24 hours after intratechal injection

amount of blood loss after cesarean delivery

时间窗: during surgery

次要结局

  • hemodynamic variables(5min before the intrathecal injection,and at 2, 4, 6, 10, 15,20 min after the injection)

研究者

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

marzieh beigom khezri

Assistant professor

Qazvin University Of Medical Sciences

研究点 (1)

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