Clinical trial NCT00676377: A New Approach of Neostigmine in Unavoidable Post Operative Ileus
Official title: A New Approach of Neostigmine in Unavoidable Post Operative Ileus After Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ileus
Keywords: Neostigmine, Post Operative, Ileus
Lead sponsor: Baqiyatallah Medical Sciences University
Sponsor class: OTHER
First posted: 2008-05-13
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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:

* 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)

Primary outcomes:
measure: show the effective way to decrease the rate of postoperative Ileus (POI).
timeFrame: 6 hours
Secondary outcomes:
measure: abdominal circumference, colonic diameters, and clinical response were again measured.
timeFrame: 3 hours
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Baqyiattalah University of Medical Science
Study officials:
affiliation: Baqyiattalah University of Medical Science
name: S.Ahmad Fanaei, M.D.
role: STUDY_CHAIR
affiliation: Erfan Hospital
name: S.Ali Ziaee, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.