A New Approach of Neostigmine in Unavoidable Post Operative Ileus
1 other identifier
interventional
3
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Aug 2007
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 12, 2008
CompletedFirst Posted
Study publicly available on registry
May 13, 2008
CompletedMay 13, 2008
May 1, 2008
4 months
May 12, 2008
May 12, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
show the effective way to decrease the rate of postoperative Ileus (POI).
6 hours
Secondary Outcomes (1)
abdominal circumference, colonic diameters, and clinical response were again measured.
3 hours
Study Arms (2)
1
EXPERIMENTALNeostigmine
2
PLACEBO COMPARATORPlacebo
Interventions
2.5 mg of neostigmine intravenously in 250 ml normal saline over a period of thirty minutes ,Half Life 3 Hours
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Baqyiattalah University of Medical Science
Tehran, Iran
Related 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. doi: 10.1056/NEJM199907153410301.
PMID: 10403850RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
S.Ahmad Fanaei, M.D.
Baqyiattalah University of Medical Science
- PRINCIPAL INVESTIGATOR
S.Ali Ziaee, M.D.
Erfan Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 12, 2008
First Posted
May 13, 2008
Study Start
August 1, 2007
Primary Completion
December 1, 2007
Study Completion
February 1, 2008
Last Updated
May 13, 2008
Record last verified: 2008-05