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Completed

NCT Number: NCT00676377

A New Approach of Neostigmine in Unavoidable Post Operative Ileus

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).

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Key information

Age range

18 year–76 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Baqyiattalah University of Medical Science

Tehran, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Neostigmine

Drug

2.5 mg of neostigmine intravenously in 250 ml normal saline over a period of thirty minutes ,Half Life 3 Hours

Other names: Neostigmine Group

Saline

Drug

Saline Placebo

Other names: Placebo Group

Primary outcomes

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

    Time frame: 6 hours

Secondary outcomes

  1. abdominal circumference, colonic diameters, and clinical response were again measured.

    Time frame: 3 hours

Sponsors and collaborators

Lead sponsor

Baqiyatallah Medical Sciences University

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2008
First posted
May 13, 2008
Registry last updated
May 13, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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