~11 spots leftby Aug 2025

Neostigmine for Colonic Pseudo-Obstruction

Palo Alto (17 mi)
Overseen byMeghan Lewis, MD
Age: Any Age
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: University of Southern California
No Placebo Group
Prior Safety Data
Approved in 3 jurisdictions

Trial Summary

What is the purpose of this trial?This trial tests neostigmine, a drug that helps reduce severe bloating in the colon, on patients with acute colonic pseudo-obstruction. It compares two methods of giving the drug: directly into a vein and under the skin, to see which is safer and more effective.
What safety data exists for neostigmine in treating colonic pseudo-obstruction?Neostigmine, administered intravenously, is effective in reducing the duration of acute colonic pseudo-obstruction (ACPO) but requires continuous cardiac monitoring due to the risk of bradycardia, which may need treatment with atropine. Subcutaneous administration may reduce cardiovascular risks while maintaining efficacy. Overall, neostigmine is considered safe with proper monitoring, though higher power studies are needed to refine patient selection and outcome monitoring.45679
Is the drug Neostigmine a promising treatment for colonic pseudo-obstruction?Yes, Neostigmine is a promising drug for treating colonic pseudo-obstruction. It has been effective in cases where other treatments failed, helping patients by improving bowel movement and resolving the condition.23678
What data supports the idea that Neostigmine for Colonic Pseudo-Obstruction is an effective drug?The available research shows that Neostigmine is effective in treating colonic pseudo-obstruction, especially when other methods don't work. One study highlights that Neostigmine helped resolve the condition in a burn patient when other treatments failed, without causing any negative side effects. Another study found that Neostigmine is recommended when conservative treatments are not successful, and it has been shown to be safe and effective in resolving the condition quickly. Overall, these studies suggest that Neostigmine is a reliable option for treating colonic pseudo-obstruction.12468
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop all current medications. However, you cannot participate if you are on beta blockers, have taken prokinetic drugs like cisapride or metoclopramide in the last 24 hours, or have active bronchospasm requiring medication.

Eligibility Criteria

This trial is for patients with a condition called acute colonic pseudo obstruction, confirmed by imaging tests like X-rays or CT scans. Their cecal diameter should be over 9 cm or transverse colon over 6 cm, and they must not have any blockages further down the bowel.

Inclusion Criteria

My tests show no blockage in my lower intestine.

Treatment Details

The study is testing two ways of giving Neostigmine to treat acute colonic pseudo obstruction: directly into the vein (IV push) and under the skin (subcutaneous). It aims to find out which method works best with fewer side effects.
2Treatment groups
Experimental Treatment
Active Control
Group I: subcutaneousExperimental Treatment1 Intervention
1.0 mg subcutaneous repeated q8hr until resolution for up to 24 hours (3.0 mg total in 24 hours)
Group II: IV pushActive Control1 Intervention
2 mg slow intravenous injection over five minutes repeated q12hr until resolution for up to 24 hours. (4 mg total in 24 hours)
Neostigmine is already approved in United States, European Union, India for the following indications:
๐Ÿ‡บ๐Ÿ‡ธ Approved in United States as Prostigmin for:
  • Myasthenia Gravis
  • Reversal of Neuromuscular Blockade
  • Urinary Retention
๐Ÿ‡ช๐Ÿ‡บ Approved in European Union as Neostigmine for:
  • Myasthenia Gravis
  • Reversal of Nondepolarizing Muscle Relaxants
๐Ÿ‡ฎ๐Ÿ‡ณ Approved in India as Neostigmine for:
  • Myasthenia Gravis
  • Reversal of Neuromuscular Blockade

Find a clinic near you

Research locations nearbySelect from list below to view details:
Los Angeles University of Southern California Medical CenterLos Angeles, CA
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Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor

References

Early resolution of Ogilvie's syndrome with intravenous neostigmine: a simple, effective treatment. [2019]Our aim was to assess the value of a parasympathomimetic drug (neostigmine) in the early resolution of acute colonic pseudo-obstruction (Ogilvie's syndrome).
Factors predicting successful outcome following neostigmine therapy in acute colonic pseudo-obstruction: a prospective study. [2013]To evaluate predictors of neostigmine response in patients with acute colonic pseudo-obstruction.
Neostigmine for the treatment of acute colonic pseudo-obstruction (ACPO) in pediatric hematologic malignancies. [2021]Acute colonic pseudo-obstruction (ACPO) refers to dilatation of the colon and decreased bowel motility without evidence of mechanical obstruction. Neostigmine, an acetylcholinesterase inhibitor, has been used in patients in whom supportive therapy failed to resolve ACPO. Here, we report the results of administering neostigmine to treat ACPO in children with hematologic malignancies.
Intravenous neostigmine for postoperative acute colonic pseudo-obstruction. [2022]To review the literature on the safety and effectiveness of neostigmine for the treatment of postoperative acute colonic pseudo-obstruction.
Does neostigmine improve time to resolution of symptoms in acute colonic pseudo-obstruction? [2013]A best evidence topic was written according to a structured protocol. In [patients with acute colonic pseudo-obstruction] is [neostigmine] superior to [conservative treatment] with respect to [duration of symptoms and complications]. In total 51 papers were found using the reported search, and ten of these represented the best evidence to answer the clinical question. The authors, date, journal, study type, population, main outcome measures and results are tabulated. We conclude that intravenous neostigmine is associated with significantly reduced duration of acute colonic pseudo-obstruction (ACPO) compared to conservative treatment alone. Neostigmine infusion should be administered with continuous cardiac monitoring for possible bradycardia, which may require treatment with atropine. Seven prospective analyses and one retrospective study showed that intravenous neostigmine reduces time to resolution of clinical and radiological features of ACPO. One prospective study showed that neostigmine is only effective in improving duration of ACPO when it is combined with proponalol. One prospective study showed no difference in time to resolution of ACPO between neostigmine and conservative treatment but this study was limited by small sample size, lack of radiological examinations and poor reporting of adverse effects. In four separate studies patients experienced bradycardia with intravenous neostigmine and this required treatment with atropine. No other significant adverse effects were reported. Overall, intravenous neostigmine is associated with a significant reduction in duration of ACPO. In addition to regularly reviewing patients for antic-cholinergic side effects, patients should undergo continuous cardiac monitoring for bradycardia. The wide variety in methodology and measurement of outcomes reinforce the need for higher power studies to improve patient selection and monitoring of outcomes.
Neostigmine to relieve a suspected colonic pseudo-obstruction in a burn patient: a case-based review of the literature. [2021]Neostigmine is one of the treatment options for colonic pseudo-obstruction in the medical patient. However, experience in using neostigmine for this indication in burn patients has not been reported in the literature. We will present a case of a woman who developed colonic pseudo-obstruction during her hospital stay. When conservative management failed, neostigmine was administered with no adverse effects and resolution of the pseudo-obstruction. We will review the literature regarding the pathophysiology and treatment options for acute colonic pseudo-obstruction in burn patients.
Efficacy and Safety of Subcutaneous Neostigmine for Ileus, Acute Colonic Pseudo-obstruction, or Refractory Constipation. [2019]Neostigmine is traditionally administered intravenously for treatment of acute colonic pseudo-obstruction (ACPO), though use is associated with administration constraints and adverse effects.
Neostigmine treatment protocols applied in acute colonic pseudo-obstruction disease: A retrospective comparative study. [2020]When conservative methods fail, neostigmine is recommended in the pharmacological treatment of acute colonic pseudo-obstruction (ACPO). The objective of this study was to analyze the response of patients to different neostigmine protocols.
Subcutaneous neostigmine appears safe and effective for acute colonic pseudo-obstruction (Ogilvie's syndrome). [2020]Intravenous neostigmine is a well-established treatment for acute colonic pseudo-obstruction (ACPO). Its use is hampered by the perceived requirement for continuous cardiac monitoring, and patients are often transferred to high-dependency units for close observation during treatment. Subcutaneous neostigmine has the potential to minimize adverse cardiovascular effects while maintaining efficacy. This study aims to assess the safety of subcutaneous neostigmine on ward inpatients with ACPO monitored with standard nursing care.