Ogilvie Syndrome Clinical Trial
Official title:
Evaluating the Safety and Efficacy of Different Routes of Neostigmine Administration for Acute Colonic Pseudo Obstruction: a Prospective Randomized Trial
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.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | August 1, 2025 |
Est. primary completion date | August 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
United States | Los Angeles University of Southern California Medical Center | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of Southern California |
United States,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients with radiographic resolution of colonic pseudo obstruction | Number of patients who have cecal diameter <9 cm AND transverse diameter <6 cm on abdominal x-ray within 24h of initiation of neostigmine therapy. | 24 hours | |
Secondary | Number of patients with recurrence of colonic pseudo obstruction | Number of patients with recurrence of cecal diameter >9cm or transverse colon diameter >6cm | 7 days | |
Secondary | Number of patients with adverse medication reactions | Number of patients that experience cardiac arrest; bradycardia, defined as a heart rate less than 60 beats/min; sustained hypotension, defined as a mean arterial pressure (MAP) less than 60 >2 min, bronchospasm documented in the medical record and needing emergent administration of albuterol or ipratropium-albuterol within 30 minutes of the dose; nausea documented in the medical record and need for emergent administration of an antiemetic within 30 minutes of the dose; or severe salivation, lacrimation, or diarrhea leading to drug discontinuation | 24 hours |
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