A New Approach of Neostigmine in Unavoidable Post Operative Ileus

This study has been completed.
Sponsor:
Information provided by:
Baqiyatallah Medical Sciences University
ClinicalTrials.gov Identifier:
NCT00676377
First received: May 12, 2008
Last updated: NA
Last verified: May 2008
History: No changes posted
  Purpose

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 Intervention Phase
Ileus
Drug: Neostigmine
Drug: Saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Official Title: A New Approach of Neostigmine in Unavoidable Post Operative Ileus After Surgery

Resource links provided by NLM:


Further study details as provided by Baqiyatallah Medical Sciences University:

Primary Outcome Measures:
  • show the effective way to decrease the rate of postoperative Ileus (POI). [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • abdominal circumference, colonic diameters, and clinical response were again measured. [ Time Frame: 3 hours ] [ Designated as safety issue: Yes ]

Enrollment: 3
Study Start Date: August 2007
Study Completion Date: February 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Neostigmine Group
Placebo Comparator: 2
Placebo
Drug: Saline
Saline Placebo
Other Name: Placebo Group

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.

  Eligibility

Ages Eligible for Study:   18 Years to 76 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00676377

Locations
Iran, Islamic Republic of
Baqyiattalah University of Medical Science
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
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
  More Information

Additional Information:
Publications:
Responsible Party: S.Ahmad Fanaei,Assistant professor of Surgery, Baqiyatallah Medical Sciences University
ClinicalTrials.gov Identifier: NCT00676377     History of Changes
Other Study ID Numbers: 8771148z
Study First Received: May 12, 2008
Last Updated: May 12, 2008
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 28, 2014