RECRUITING

Neostigmine Route for Acute Colonic Pseudo Obstruction

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Conditions

Ogilvie Syndrome

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Evaluating the Safety and Efficacy of Different Routes of Neostigmine Administration for Acute Colonic Pseudo Obstruction: a Prospective Randomized Trial

Quick Facts

Study Start:2022-02-04
Study Completion:2025-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04951726

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients with radiologically confirmed acute colonic pseudo obstruction (ACPO).
  2. 1. Plain abdominal radiograph or computed tomography imaging
  3. 2. Cecal diameter of \>9 cm or transverse colon diameter of \>6 cm
  4. 2. Distal obstruction ruled out on imaging (Contrast enema, endoscopy, CT scan)
  1. 1. Patients with previous neostigmine administration during current hospitalization
  2. 2. Patients with prior attempt at endoscopic decompression on this admission.
  3. 3. Patients with base-line heart rate of less than 60 beats per minute or on beta blocker medication
  4. 4. Patients with systolic blood pressure of less than 90 mm Hg
  5. 5. Signs of bowel perforation, with peritoneal signs on physical examination or free air on radiographs
  6. 6. Active bronchospasm requiring medication
  7. 7. Treatment with prokinetic drugs such as cisapride or metoclopramide in the 24 hours before evaluation
  8. 8. A history of colon cancer or partial colonic resection
  9. 9. Signs concerning for colonic obstruction
  10. 10. Active gastrointestinal bleeding
  11. 11. Pregnancy
  12. 12. Serum creatinine concentration of more than 3 mg per deciliter (265μmol per liter).

Contacts and Locations

Study Contact

Jordan Wlodarczyk, md
CONTACT
7143579599
jordan.wlodarczyk@med.usc.edu
Meghan Lewis, MD
CONTACT
3108014070
meghan.lewis@med.usc.edu

Principal Investigator

Meghan Lewis, MD
PRINCIPAL_INVESTIGATOR
University of Southern California

Study Locations (Sites)

Los Angeles University of Southern California Medical Center
Los Angeles, California, 90004
United States

Collaborators and Investigators

Sponsor: University of Southern California

  • Meghan Lewis, MD, PRINCIPAL_INVESTIGATOR, University of Southern California

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-04
Study Completion Date2025-08-01

Study Record Updates

Study Start Date2022-02-04
Study Completion Date2025-08-01

Terms related to this study

Additional Relevant MeSH Terms

  • Ogilvie Syndrome