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临床试验/NCT00676377
NCT00676377已完成4 期

A New Approach of Neostigmine in Unavoidable Post Operative Ileus After Surgery

Baqiyatallah Medical Sciences University1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2007年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
3
试验地点
1
主要终点
show the effective way to decrease the rate of postoperative Ileus (POI).

研究概览

简要总结

Postoperative ileus (POI) in the absence of any mechanical obstruction remains a commonly encountered clinical problem.So, this study aimed to show the effective way to decrease the rate of postoperative Ileus (POI).

详细描述

We honestly declare that, the use of parasympathomimetic agents such as neostigmine is not without risk. Patients with underlying bradyarrhythmias or those receiving β-adrenergic antagonists may be more susceptible to neostigmine-induced bradycardia. Similarly, neostigmine increases airway secretions and bronchial reactivity, which may exacerbate active bronchospasm. Recently, a new class of drugs-peripherally acting mu-opioid receptor antagonists-may help enhance multimodal management of POI. Although, the cost benefit of the new class of drugs is debated. It has been suggested that the individual components of multimodal protocols-for example, laparoscopy-may reduce certain post surgical morbidities (including POI) But do not by them prevent POI. Therefore, combinations of strategies with demonstrated effectiveness-early feeding , epidural analgesia, laparoscopic surgery, and use of peripherally acting mu-opioid-receptor antagonists-may help transform the reactive approach to POI into a proactive multimodal paradigm that effectively targets the diverse etiologic factors leading to this common clinical problem.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 76 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with acute colonic pseudo-obstruction who were 18 years of age or older
  • Patients had to have a cecal diameter of at least 10 cm on plain radiographs
  • Mechanical obstruction was ruled out by the finding of air throughout all colonic segments including the rectosigmoid on plain abdominal radiographs

排除标准

  • Exclusion criteria included a base-line heart rate of less than 60 beats per minute or systolic blood pressure of less than 90 mm Hg; signs of bowel perforation
  • With peritoneal signs on physical examination or free air on radiographs; active bronchospasm requiring medication
  • Treatment with prokinetic drugs such as cisapride or metoclopramide in the 24 hours before evaluation
  • A history of colon cancer or partial colonic resection
  • Active gastrointestinal bleeding
  • Pregnancy
  • Positive history of Myocardial Infarction, Intestinal Resection or a serum creatinine concentration of more than 3 mg per deciliter (265 µmol per liter)

研究组 & 干预措施

1

Experimental

Neostigmine

干预措施: Neostigmine (Drug)

2

Placebo Comparator

Placebo

干预措施: Saline (Drug)

结局指标

主要结局

show the effective way to decrease the rate of postoperative Ileus (POI).

时间窗: 6 hours

次要结局

  • abdominal circumference, colonic diameters, and clinical response were again measured.(3 hours)

研究者

发起方
Baqiyatallah Medical Sciences University
申办方类型
Other

研究点 (1)

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