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A New Approach of Neostigmine in Unavoidable Post Operative Ileus

Primary Purpose

Ileus

Status
Completed
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Neostigmine
Saline
Sponsored by
Baqiyatallah Medical Sciences University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Ileus focused on measuring Neostigmine, Post Operative, Ileus

Eligibility Criteria

18 Years - 76 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Baqyiattalah University of Medical Science

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Neostigmine

Placebo

Outcomes

Primary Outcome Measures

show the effective way to decrease the rate of postoperative Ileus (POI).

Secondary Outcome Measures

abdominal circumference, colonic diameters, and clinical response were again measured.

Full Information

First Posted
May 12, 2008
Last Updated
May 12, 2008
Sponsor
Baqiyatallah Medical Sciences University
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1. Study Identification

Unique Protocol Identification Number
NCT00676377
Brief Title
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

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Baqiyatallah Medical Sciences University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ileus
Keywords
Neostigmine, Post Operative, Ileus

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Neostigmine
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Neostigmine
Other Intervention Name(s)
Neostigmine Group
Intervention Description
2.5 mg of neostigmine intravenously in 250 ml normal saline over a period of thirty minutes ,Half Life 3 Hours
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
Placebo Group
Intervention Description
Saline Placebo
Primary Outcome Measure Information:
Title
show the effective way to decrease the rate of postoperative Ileus (POI).
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
abdominal circumference, colonic diameters, and clinical response were again measured.
Time Frame
3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
S.Ahmad Fanaei, M.D.
Organizational Affiliation
Baqyiattalah University of Medical Science
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
S.Ali Ziaee, M.D.
Organizational Affiliation
Erfan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baqyiattalah University of Medical Science
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
10403850
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.
Results Reference
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A New Approach of Neostigmine in Unavoidable Post Operative Ileus

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