Comparing two ways to give neostigmine for treating acute colonic pseudo obstruction
Evaluating the Safety and Efficacy of Different Routes of Neostigmine Administration for Acute Colonic Pseudo Obstruction: a Prospective Randomized Trial
This study is testing two different ways to give neostigmine to see which one works better and is safer for people with acute colonic pseudo obstruction.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | University of Southern California Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT04951726 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the efficacy and side effect profiles of two different administration routes for neostigmine in patients with acute colonic pseudo obstruction (ACPO). The study will compare intravenous push and subcutaneous methods to determine which is more effective and safer for patients. ACPO is a serious condition that can lead to complications such as colonic perforation, and finding a non-invasive treatment option is crucial. The trial will include patients with confirmed ACPO and will exclude those with certain contraindications.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with radiologically confirmed acute colonic pseudo obstruction and specific cecal or transverse colon diameters.
Not a fit: Patients with previous neostigmine administration during their current hospitalization or those with signs of bowel perforation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective treatment option for patients suffering from acute colonic pseudo obstruction.
How similar studies have performed: While neostigmine has shown effectiveness in treating ACPO, this specific comparison of administration routes is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with radiologically confirmed acute colonic pseudo obstruction (ACPO). 1. Plain abdominal radiograph or computed tomography imaging 2. Cecal diameter of \>9 cm or transverse colon diameter of \>6 cm 2. Distal obstruction ruled out on imaging (Contrast enema, endoscopy, CT scan) Exclusion Criteria: 1. Patients with previous neostigmine administration during current hospitalization 2. Patients with prior attempt at endoscopic decompression on this admission. 3. Patients with base-line heart rate of less than 60 beats per minute or on beta blocker medication 4. Patients with systolic blood pressure of less than 90 mm Hg 5. Signs of bowel perforation, with peritoneal signs on physical examination or free air on radiographs 6. Active bronchospasm requiring medication 7. Treatment with prokinetic drugs such as cisapride or metoclopramide in the 24 hours before evaluation 8. A history of colon cancer or partial colonic resection 9. Signs concerning for colonic obstruction 10. Active gastrointestinal bleeding 11. Pregnancy 12. Serum creatinine concentration of more than 3 mg per deciliter (265μmol per liter).
Where this trial is running
Los Angeles, California
- Los Angeles University of Southern California Medical Center — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Meghan Lewis, MD — University of Southern California
- Study coordinator: Jordan Wlodarczyk, md
- Email: jordan.wlodarczyk@med.usc.edu
- Phone: 7143579599
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.