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临床试验/NCT05137288
NCT05137288Unknown不适用

Intrathecal Atropine Versus Preoperative Intravenous Ondasetron for Prevention of Postoperative Nausea and Vomiting Due to Intrathecal Morphine in Perineal Surgery

Sohag University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年12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
入组人数
100
试验地点
1
主要终点
frequency of attacks of postoperative nausea and vomiting

研究概览

简要总结

To compare between intrathecal atropine versus preoperative administration of IV ondansetron in decreasing incidence of post operative nausea and vomiting related to intrathecal opioids in post operative period in perineal surgery as regard : efficacy and side effects .

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
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age between ( 18 - 45 ) years.
  • Body mass index between ( 18.5 - 35 )
  • patients undergoing perineal surgery as anal fissure , piles and rectocele
  • patients receiving bupivacaine ( 20 mg / 4 ml ) as spinal anesthesia
  • Patinets with physical status 1 or 2 according to ASA classification

排除标准

  • Patient refusal .
  • Any contraindication of neuraxial block as : coagulopathy , skin infection at injection site or bacteremia , hypovolemia and shock , history of allergy to L.A , sever aortic stenosis or mitral stenosis ......... etc
  • Patients with physical status other than 1 and 2 according to ASA classification
  • Those with history of nausea and vomiting , also those who received anti emetic drugs in last 2 hours of operation .
  • Allergy to any of the drug included in this study .

研究组 & 干预措施

patients receiving intrathecal atropine

Active Comparator

Patient received intrathecal hyperbaric bupivacaine ( 10 mg ) ( 2 ml 0.5% ) with morphine 250mic and atropine sulphate 100 micwith total volume = 2.5 ml .

干预措施: Ondansetron , atropine and bupivacaine (Drug)

patients receiving preoperative intravenous ondasetron

Active Comparator

Patient received intrathecal hyperbaric bupivacaine ( 10 mg ) ( 2 ml 0.5% with 0.5 ml normal saline with morphine 250 mic ) with total volume = 2.5 ml with giving 4 mg IV ondansetron before anesthesia ( patients with body weight more than 80 Kg may need additional 4 mg IV ) .

干预措施: Ondansetron , atropine and bupivacaine (Drug)

结局指标

主要结局

frequency of attacks of postoperative nausea and vomiting

时间窗: 6-9 months

Intrathecal atropine versus preoperative intravenous ondasetron for prevention of postoperative nausea and vomiting due to intrathecal morphine

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

Shehab Mahmoud Mohamed

resident doctor at anesthesia and ICU department sohag university hospital

Sohag University

研究点 (1)

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