A New Approach of Neostigmine in Unavoidable Post Operative Ileus
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| First Received Date ICMJE | May 12, 2008 | ||||||||
| Last Updated Date | May 12, 2008 | ||||||||
| Start Date ICMJE | August 2007 | ||||||||
| Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
show the effective way to decrease the rate of postoperative Ileus (POI). [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
abdominal circumference, colonic diameters, and clinical response were again measured. [ Time Frame: 3 hours ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | A New Approach of Neostigmine in Unavoidable Post Operative Ileus | ||||||||
| Official Title ICMJE | A New Approach of Neostigmine in Unavoidable Post Operative Ileus After Surgery | ||||||||
| 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). |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Supportive Care |
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| Condition ICMJE | Ileus | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | 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. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 3 | ||||||||
| Completion Date | February 2008 | ||||||||
| Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 76 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Iran, Islamic Republic of | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00676377 | ||||||||
| Other Study ID Numbers ICMJE | 8771148z | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | S.Ahmad Fanaei,Assistant professor of Surgery, Baqiyatallah Medical Sciences University | ||||||||
| Study Sponsor ICMJE | Baqiyatallah Medical Sciences University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Baqiyatallah Medical Sciences University | ||||||||
| Verification Date | May 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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