A New Approach of Neostigmine in Unavoidable Post Operative Ileus

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Ileus

Intervention / Treatment
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* Drug: Neostigmine
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 76 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Neostigmine | Drug: Neostigmine<br>* 2.5 mg of neostigmine intravenously in 250 ml normal saline over a period of thirty minutes ,Half Life 3 Hours<br>* Other names: Neostigmine Group;|
| Placebo Comparator: 2<br>Placebo | Drug: Saline<br>* Saline Placebo<br>* Other names: Placebo Group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| show the effective way to decrease the rate of postoperative Ileus (POI). |  | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| abdominal circumference, colonic diameters, and clinical response were again measured. |  | 3 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neostigmine, Post Operative, Ileus