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临床试验/NCT04033471
NCT04033471Unknown1 期

Effect of Epidural Morphine and Midazolam on Postoperative Painin Patients Undergoing Major Abdominal Cancer Surgery

Assiut University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
入组人数
20
试验地点
1
主要终点
time to first request of analgesia

研究概览

简要总结

this study aim to Compare the effect of preoperative Epidural Midazolam, Morphine and their combination in postoperative pain relief and total morphine consumption.

详细描述

Major abdominal surgeries with abdominal incisions lead to severe abdominal pain, which if treated inadequately, can cause shallow breathing, atelectasis, retention of secretions and lack of cooperation in physiotherapy. This increases the incidence of post-operative morbidity and leads to delayed recovery.Epidural anesthesia is safe and inexpensive technique with the advantage of providing surgical anesthesia and prolonged postoperative pain relief. It also an effective treatment of operative pain blunts autonomic, somatic and endocrine responses. Morphine and midazolam can be used as adjuvant to bupivicain to reduced the postoperative pain

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA I-II patients scheduled for major abdominal cancer surgeries

排除标准

  • patients with known allergy to the study drugs,
  • significant cardiac, respiratory, renal or hepatic disease,
  • drug or alcohol abuse,
  • psychiatric illness that would interfere with perception and assessment of pain.

研究组 & 干预措施

MI

Active Comparator

Bupivacaine 0.25% + midazolam 5mg in total volume 10m1

干预措施: midazolam (Drug)

MM

Active Comparator

Bupivacaine 0.25% + midazolam 5mg and morphine 5mg in total volume 10ml

干预措施: midazolam (Drug)

MO

Active Comparator

bupivacaine 0.25% + morphine 5 mg in total volume 10 ml

干预措施: midazolam (Drug)

结局指标

主要结局

time to first request of analgesia

时间窗: 1st 48 hours postoperative

the time between the end of operation and tracheal extubation to the first request for supplemental analgesics and its administration to the patient

次要结局

  • the cumulative consumption of morphine in the 1st 48h postoperatively(1st 48 hours postoperative)

研究者

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

Shereen Mamdouh

associate professor of anesthesia, ICU and pain manegement

Assiut University

研究点 (1)

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