Neostigmine for Colonic Pseudo-Obstruction
Recruiting in Palo Alto (17 mi)
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: University of Southern California
Must not be taking: Beta blockers, Prokinetics
Disqualifiers: Bradycardia, Hypotension, Bronchospasm, others
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have taken prokinetic drugs like cisapride or metoclopramide in the 24 hours before evaluation.
What data supports the effectiveness of the drug Neostigmine for treating colonic pseudo-obstruction?
Research shows that Neostigmine is effective in resolving acute colonic pseudo-obstruction, especially when other treatments don't work. Studies have found it to be a safe and effective option for this condition, with successful outcomes reported in various cases.
12345Is neostigmine safe for treating colonic pseudo-obstruction?
Neostigmine is generally safe for treating colonic pseudo-obstruction, but it can cause bradycardia (slow heart rate), which may need treatment with atropine. Patients receiving intravenous neostigmine should have continuous heart monitoring to watch for this side effect.
13678How is the drug Neostigmine unique in treating colonic pseudo-obstruction?
Neostigmine is unique because it is an acetylcholinesterase inhibitor, which means it helps increase bowel movement by preventing the breakdown of a chemical that stimulates muscle contractions. It is often used when other treatments fail and can be administered intravenously or subcutaneously, offering flexibility in treatment options.
12579Eligibility 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.
Patients with radiologically confirmed acute colonic pseudo obstruction (ACPO).
Plain abdominal radiograph or computed tomography imaging
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants receive neostigmine via IV push or subcutaneous routes for up to 24 hours
24 hours
Continuous monitoring during treatment
Follow-up
Participants are monitored for recurrence of colonic pseudo obstruction and adverse reactions
7 days
Participant Groups
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:
๐บ๐ธ Approved in United States as Prostigmin for:
- Myasthenia Gravis
- Reversal of Neuromuscular Blockade
- Urinary Retention
๐ช๐บ Approved in European Union as Neostigmine for:
- Myasthenia Gravis
- Reversal of Nondepolarizing Muscle Relaxants
๐ฎ๐ณ 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
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.
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.
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.
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.
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.
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.
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.
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.