Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Baqiyatallah Medical Sciences University |
---|---|
Information provided by: | Baqiyatallah Medical Sciences University |
ClinicalTrials.gov Identifier: | NCT00676377 |
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).
Condition | Intervention | Phase |
---|---|---|
Ileus |
Drug: Neostigmine Drug: Saline |
Phase IV |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A New Approach of Neostigmine in Unavoidable Post Operative Ileus After Surgery |
Enrollment: | 3 |
Study Start Date: | August 2007 |
Study Completion Date: | February 2008 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Neostigmine
|
Drug: Neostigmine
2.5 mg of neostigmine intravenously in 250 ml normal saline over a period of thirty minutes ,Half Life 3 Hours
|
2: Placebo Comparator
Placebo
|
Drug: Saline
Saline Placebo
|
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.
Ages Eligible for Study: | 18 Years to 76 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Iran, Islamic Republic of | |
Baqyiattalah University of Medical Science | |
Tehran, Iran, Islamic Republic of |
Study Chair: | S.Ahmad Fanaei, M.D. | Baqyiattalah University of Medical Science |
Principal Investigator: | S.Ali Ziaee, M.D. | Erfan Hospital |
Responsible Party: | Baqiyatallah Medical Sciences University ( S.Ahmad Fanaei,Assistant professor of Surgery ) |
Study ID Numbers: | 8771148z |
Study First Received: | May 12, 2008 |
Last Updated: | May 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00676377 |
Health Authority: | United States: Institutional Review Board |
Neostigmine, Post Operative, Ileus |
Intestinal Obstruction Ileus Neostigmine |
Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases |
Parasympathomimetics Cholinesterase Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Autonomic Agents |
Physiological Effects of Drugs Enzyme Inhibitors Peripheral Nervous System Agents Cholinergic Agents Pharmacologic Actions |