A New Approach of Neostigmine in Unavoidable Post Operative Ileus

NCT ID: NCT00676377

Last Updated: 2008-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2008-02-29

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).

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.

Conditions

Ileus

Keywords

Neostigmine, Post Operative, Ileus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

1

Neostigmine

Group Type: EXPERIMENTAL

Neostigmine

Intervention Type: DRUG

2.5 mg of neostigmine intravenously in 250 ml normal saline over a period of thirty minutes ,Half Life 3 Hours

2

Placebo

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

Saline Placebo

Interventions

Neostigmine

2.5 mg of neostigmine intravenously in 250 ml normal saline over a period of thirty minutes ,Half Life 3 Hours

Intervention Type: DRUG

Saline

Saline Placebo

Intervention Type: DRUG

Other Intervention Names

Neostigmine Group; Placebo Group

Eligibility 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

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 76 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baqiyatallah Medical Sciences University

OTHER

Sponsor Role: lead

Responsible Party

Baqiyatallah Medical Sciences University

Principal Investigators

S.Ahmad Fanaei, M.D.

Role: STUDY_CHAIR

Baqyiattalah University of Medical Science

S.Ali Ziaee, M.D.

Role: PRINCIPAL_INVESTIGATOR

Erfan Hospital

Locations

Baqyiattalah University of Medical Science

Tehran, , Iran

Countries

Iran

References

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.

Reference Type: RESULT

PMID: 10403850 (View on PubMed)

Other Identifiers

8771148z

Identifier Type: -

Identifier Source: org_study_id