Recruiting

Neostigmine

Sponsor:

University of Southern California

Code:

NCT04951726

Conditions

Ogilvie Syndrome

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Interventions

Neostigmine

Study Details

Brief 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.

Conditions

Ogilvie Syndrome

Study ID

NCT04951726

Start date

Feb 4, 2022

Status verified date

Aug, 2023

Completion date

Aug 1, 2025

Anticipated

Primary completion date

Aug 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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)

Interventions

Neostigmine

cholinesterase inhibitor

Primary outcome measure

  • Number of patients with radiographic resolution of colonic pseudo obstruction [ Time Frame: 24 hours ]

Central Contacts and Locations

Central contacts

Locations

Los Angeles University of Southern California Medical Center

Recruiting

Los Angeles, California, United States, 90004

Contacts

More Information

Sponsor

University of Southern California

Last update posted

Aug 25, 2023

Last verified

Aug, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Southern California on 2023-08-25.