A New Approach of Neostigmine in Unavoidable Post Operative Ileus

Phase 4

Completed

• Conditions: Ileus
• Interventions: Drug: Neostigmine; Drug: Saline

• Registration Number: NCT00676377
• Lead Sponsor: Baqiyatallah Medical Sciences University

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-08
• Primary Completion: 2007-12
• Study Completion: 2008-02
• Status Verified: 2008-05
• Study First Submitted: 2008-05-12
• Study First Submitted QC: 2008-05-12
• Last Update Submitted: 2008-05-12
• Study First Posted: 2008-05-13
• Last Update Posted: 2008-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Neostigmine	Neostigmine
2	Saline	Placebo

Primary Outcome Measures

Name	Time	Method
show the effective way to decrease the rate of postoperative Ileus (POI).	6 hours

Secondary Outcome Measures

Name	Time	Method
abdominal circumference, colonic diameters, and clinical response were again measured.	3 hours

Trial Locations

Locations (1)

Baqyiattalah University of Medical Science; 🇮🇷 Tehran, Iran, Islamic Republic of