A New Approach of Neostigmine in Unavoidable Post Operative Ileus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00676377
Recruitment Status : Completed
First Posted : May 13, 2008
Last Update Posted : May 13, 2008
Information provided by:
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).

Condition or disease Intervention/treatment Phase
Ileus Drug: Neostigmine Drug: Saline Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: A New Approach of Neostigmine in Unavoidable Post Operative Ileus After Surgery
Study Start Date : August 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Drug: Neostigmine
2.5 mg of neostigmine intravenously in 250 ml normal saline over a period of thirty minutes ,Half Life 3 Hours
Other Name: Neostigmine Group

Placebo Comparator: 2
Drug: Saline
Saline Placebo
Other Name: Placebo Group

Primary Outcome Measures :
  1. show the effective way to decrease the rate of postoperative Ileus (POI). [ Time Frame: 6 hours ]

Secondary Outcome Measures :
  1. abdominal circumference, colonic diameters, and clinical response were again measured. [ Time Frame: 3 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 76 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00676377

Iran, Islamic Republic of
Baqyiattalah University of Medical Science
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Baqiyatallah Medical Sciences University
Study Chair: S.Ahmad Fanaei, M.D. Baqyiattalah University of Medical Science
Principal Investigator: S.Ali Ziaee, M.D. Erfan Hospital

Additional Information:
Publications of Results:
Responsible Party: S.Ahmad Fanaei,Assistant professor of Surgery, Baqiyatallah Medical Sciences University Identifier: NCT00676377     History of Changes
Other Study ID Numbers: 8771148z
First Posted: May 13, 2008    Key Record Dates
Last Update Posted: May 13, 2008
Last Verified: May 2008

Keywords provided by Baqiyatallah Medical Sciences University:
Neostigmine, Post Operative, Ileus

Additional relevant MeSH terms:
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents