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临床试验/NCT03209427
NCT03209427已完成4 期

Pruritus After Intrathecal Morphine in Cesarean Section: Incidence, Severity and Its Relation to Serum Serotonin Level

Assiut University0 个研究点目标入组 40 人开始时间: 2014年4月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
40
主要终点
Pruritus

研究概览

简要总结

Pruritus is the commonest side effect of intrathecal morphine especially in parturient, but the exact mechanism of pruritus is not clear. Many mechanisms have been suggested. Among these mechanisms is the activation of the 5-HT3 receptors by the intrathecally injected morphine.

详细描述

Forty parturients underwent elective cesarean section under spinal anesthesia were divided into two groups of 20 each in this prospective randomized study. Group I received 100 µg of intrathecal morphine (ITM) mixed with 12 mg of 0.5% heavy bupivacaine (M100) while group II received 200 µg of ITM mixed with 12 mg of 0.5% heavy bupivacaine (M200). Two blood samples were taken from each patient for serotonin estimation, preoperatively and 4 hrs later. Postoperatively all patients were assessed for pruritus (incidence & severity), visual analog scale (VAS), first request of analgesia, and total analgesic dose required within 24 hrs.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
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

  • ASA I - II term pregnant patients scheduled for elective cesarean section

排除标准

  • patients with a known allergy to the study drugs
  • significant cardiac, respiratory, renal, neurological, or hepatic disease; -coagulation disorders
  • BMI > 30 kg/m2
  • any itchy skin diseases.

研究组 & 干预措施

Group I

Active Comparator

intrathecal injection of 100 μg morphine

干预措施: Morphine 100 μg (Drug)

Group II

Active Comparator

iIntrathecal injection of 200 μg morphine

干预措施: Morphine 200 μg (Drug)

结局指标

主要结局

Pruritus

时间窗: 24 hours postoperative

severity

次要结局

  • serotonin(4 hours postoperative)

研究者

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

Mohamed galal aly

Assistant professor

Assiut University

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