Evaluating the Safety and Efficacy of Different Routes of Neostigmine Administration for Acute Colonic Pseudo Obstruction: a Prospective Randomized Trial
Who is this study for? Patients with acute colonic pseudo obstruction
What treatments are being studied? Neostigmine
Status: Unknown
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
Neostigmine is commonly used for medical treatment of acute colonic pseudo obstruction, however, the ideal route of administration has not been determined. Though IV push works rapidly, it is likely associated with the most side effects. This study will compare the efficacy and side effect profile of 2 potential routes of administration: IV push and subcutaneous.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: f
View:
• Patients with radiologically confirmed acute colonic pseudo obstruction (ACPO).
‣ Plain abdominal radiograph or computed tomography imaging
⁃ Cecal diameter of \>9 cm or transverse colon diameter of \>6 cm
• Distal obstruction ruled out on imaging (Contrast enema, endoscopy, CT scan)
Locations
United States
California
Los Angeles University of Southern California Medical Center
RECRUITING
Los Angeles
Contact Information
Primary
Jordan Wlodarczyk, md
jordan.wlodarczyk@med.usc.edu
7143579599
Backup
Meghan Lewis, MD
meghan.lewis@med.usc.edu
3108014070
Time Frame
Start Date: 2022-02-04
Completion Date: 2025-08-01
Participants
Target number of participants: 90
Treatments
Active_comparator: IV push
2 mg slow intravenous injection over five minutes repeated q12hr until resolution for up to 24 hours. (4 mg total in 24 hours)
Experimental: subcutaneous
1.0 mg subcutaneous repeated q8hr until resolution for up to 24 hours (3.0 mg total in 24 hours)
Related Therapeutic Areas
Sponsors
Leads: University of Southern California