A New Approach of Neostigmine in Unavoidable Post Operative Ileus

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

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).

Study Overview

• Status: Completed
• Conditions: Ileus
• Intervention / Treatment: Drug: Neostigmine; Drug: Saline

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
• Enrollment (Actual): 3
• Phase: Phase 4

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Baqyiattalah University of Medical Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2; Placebo	Drug: Saline; Saline Placebo; Other Names: Placebo Group
Experimental: 1; Neostigmine	Drug: Neostigmine; 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Baqiyatallah Medical Sciences University
• Investigators: Study Chair: S.Ahmad Fanaei, M.D., Baqyiattalah University of Medical Science; Principal Investigator: S.Ali Ziaee, M.D., Erfan hospital

Publications and helpful links

General Publications

• Ponec RJ, Saunders MD, Kimmey MB. Neostigmine for the treatment of acute colonic pseudo-obstruction. N Engl J Med. 1999 Jul 15;341(3):137-41. doi: 10.1056/NEJM199907153410301.

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: May 12, 2008
• First Submitted That Met QC Criteria: May 12, 2008
• First Posted (Estimate): May 13, 2008

Study Record Updates

• Last Update Posted (Estimate): May 13, 2008
• Last Update Submitted That Met QC Criteria: May 12, 2008
• Last Verified: May 1, 2008

More Information

Terms related to this study

• Keywords: Neostigmine, Post Operative, Ileus
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction; Ileus; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Cholinesterase Inhibitors; Parasympathomimetics; Neostigmine
• Other Study ID Numbers: 8771148z