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临床试验/NCT03344393
NCT03344393Unknown不适用

Effect of Intraoperative IV Ketamine on Postoperative Morphine Consumption During Intestinal Surgery and Its Effect on Salivary Cortisol and Alpha Amylase Levels

Assiut University0 个研究点目标入组 60 人开始时间: 2017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
60
主要终点
morphine consumption

研究概览

简要总结

.The aim of this study is to identify the analgesic effect of intraoperative ketamine intravenous infusion on patients undergoing intestinal surgery and its effect on salivary cortisol and alpha amylase levels as indicator of its effect.

详细描述

I- Group K (ketamine): 30 patients will receive intraoperative intravenous ketamine infusion.

II- Group C (control): 30 patients will receive intraoperative intravenous normal saline infusion.

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
Single (Investigator)

入排标准

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

入选标准

  • - Patient's status ASA status-I and II.
  • Patients age above 18 years old.
  • Patients scheduled for intestinal surgery.

排除标准

  • Patient refusal.
  • Patients with known allergy to ketamine or morphine.
  • Patients with significant hepatic dysfunction.
  • Patients with severe renal disease.
  • Significant Heart disease.
  • Patients with chronic pain.
  • Regular use analgesics, antidepressants or opioids in last 2 months.
  • Any known convulsive disorder.
  • Morbid obesity (BMI>35).
  • Patients with autoimmune disease
  • Patients on corticosteroid therapy
  • Pregnancy.
  • Breast feeding.
  • Woman under hormonal treatment.
  • Oral disease.

研究组 & 干预措施

ketamine hydrochloride

Active Comparator

intravenous ketamine infusion in the intraoperative period

干预措施: Ketamine Hydrochloride (Drug)

normal saline

Active Comparator

intravenous normal saline infusion in the intraoperative period

干预措施: Normal saline (Drug)

结局指标

主要结局

morphine consumption

时间窗: 2 days postoperative

IV PCA

次要结局

  • cortisol level(2 days postoperative)
  • alpha amylase level(2 days 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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