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临床试验/NCT06747975
NCT06747975尚未招募4 期

Preventative Effect of Combining Dexamethasone with Ondansetron on Postoperative Nausea, Vomiting and Shivering in Children Undergoing Caudal Anesthesia

Assiut University0 个研究点目标入组 100 人开始时间: 2025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
4 期
状态
尚未招募
入组人数
100
主要终点
the incidence of all emesis

研究概览

简要总结

caudal epidural block is a technique used as an adjuvant to general anesthesia for postoperative analgesia in pediatric patients,especially those with infraumbilical, perineal and lower extremity surgery , because it reduces the need for perioperative and postoperative analgesia, reduces the need for general anesthesia, accelerates the awakening, suppresses the surgical neurohumoral stress response and can be performed easily The objective of the current study is to determine the efficacy and safety of prophylactic intravenous administration of combination of 0.1mg/kg of dexamethasone plus 4mg of ondansetron immediately before establishment of caudal block for prevention of Nausea&vomiting and Shivering in pediatric patients undergoing infra umbilical surgeries

详细描述

Although it has some adverse effects: postoperative nausea and vomiting (PONV) are frequent and morbidity-related complication in children, PONV is still present in almost twice the frequency of adults, 33.2-82%. shivering is one of frequent, undesirable adverse effects, The incidence of shivering is up to 40-60% even in regional anaesthesia leads to O2 consumption and CO2 production,So we target in this study two effective drugs with less side effects to reduse these adverse effects Ondansetron is a highly potent selective 5 hydroxytryptamine receptor antagonist, which is widely used as an anti-emetic, Its mechanism of action as anti-shivering is not clear and it is proposed to act centrally at the level of the pre-optic anterior hypothalamic region by inhibition of serotonin reuptake Dexamethasone: is a potent class of steroid drugs ,It prevents thermoregulatory shivering via its central inhibitory effect on the thermoregulatory center and prevents non thermoregulatory shivering by its anti-inflammatory activity, i.e. antagonizing the activation of the inflammatory responses and release of cytokines during surgery The anti-emetic properties of dexamethasone are well established but the mechanisms underlying this anti-emetic effect remain largely unknown

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
2 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age from 2 to 12 years old.
  • Patients with stable vital signs.
  • Patients with normal laboratory investigations.
  • Patients undergoing Caudal anaesthesia for infraumbilical surgeries

排除标准

  • Patient's parental refusal.
  • Age < 2 or > 12 years.
  • Contraindications to Caudal anaesthesia (Coagulopathy, increased intracranial pressure, or local skin infection ,pilonidal cyst and congenital anomalies of lower spine because of unclear or impalpable anatomy
  • Patients with cardiac morbidities.
  • Failure of caudal block
  • Diabetes mellitus
  • Convulsions.
  • Known allergy to any drugs used in this study.

研究组 & 干预措施

group A

Experimental

fifty patients will receive Caudal epidural block (0.5 mL/kg of bupivacaine 0.25% plus dexa- methasone 0.1 mg/kg plus 4mg ondansetron ), and IV 5 mL normal saline

干预措施: Dexamethasone and Ondansetron (Drug)

group A

Experimental

fifty patients will receive Caudal epidural block (0.5 mL/kg of bupivacaine 0.25% plus dexa- methasone 0.1 mg/kg plus 4mg ondansetron ), and IV 5 mL normal saline

干预措施: Bupivacaine + saline (Drug)

group B

Placebo Comparator

fifty patients will receive Caudal epidural block (0.5 mL/kg of bupivacaine 0.25% plus dexa- methasone 0.1 mg/kg plus 4mg ondansetron ), and IV 5 mL normal saline

干预措施: Bupivacaine + saline (Drug)

结局指标

主要结局

the incidence of all emesis

时间窗: 24 hours

the incidence of all emesis in the 24 h after surgery (PONV).

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

Abdelrahman Fathy Ahmed

resident doctor at Assiut University hospital

Assiut University

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