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

May 12, 2008
May 12, 2008
August 2007
December 2007   (final data collection date for primary outcome measure)
show the effective way to decrease the rate of postoperative Ileus (POI). [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
abdominal circumference, colonic diameters, and clinical response were again measured. [ Time Frame: 3 hours ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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).

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Ileus
  • 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
  • Drug: Saline
    Saline Placebo
    Other Name: Placebo Group
  • Experimental: 1
    Neostigmine
    Intervention: Drug: Neostigmine
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Saline
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3
February 2008
December 2007   (final data collection date for primary outcome measure)

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)
Both
18 Years to 76 Years
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT00676377
8771148z
Yes
S.Ahmad Fanaei,Assistant professor of Surgery, Baqiyatallah Medical Sciences University
Baqiyatallah Medical Sciences University
Not Provided
Study Chair: S.Ahmad Fanaei, M.D. Baqyiattalah University of Medical Science
Principal Investigator: S.Ali Ziaee, M.D. Erfan Hospital
Baqiyatallah Medical Sciences University
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP