A New Approach of Neostigmine in Unavoidable Post Operative Ileus

Ileus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00676377
• Other study ID #: 8771148z
• Status: Completed
• Phase: Phase 4
• First received: May 12, 2008
• Last updated: May 12, 2008
• Start date: August 2007
• Est. completion date: February 2008

Study information

• Verified date: May 2008
• Source: Baqiyatallah Medical Sciences University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: February 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 76 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Ileus

Intervention

Drug:
• Neostigmine
2.5 mg of neostigmine intravenously in 250 ml normal saline over a period of thirty minutes ,Half Life 3 Hours
• Saline
Saline Placebo

Locations

Country	Name	City	State
Iran, Islamic Republic of	Baqyiattalah University of Medical Science	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Baqiyatallah Medical Sciences University

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	show the effective way to decrease the rate of postoperative Ileus (POI).		6 hours	Yes
Secondary	abdominal circumference, colonic diameters, and clinical response were again measured.		3 hours	Yes

External Links

•   Burden of Post Operative Ileus,Last Poster