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A New Approach of Neostigmine in Unavoidable Post Operative Ileus

B

Baqiyatallah Medical Sciences University

Status and phase

Completed
Phase 4

Conditions

Ileus

Treatments

Drug: Saline
Drug: Neostigmine

Study type

Interventional

Funder types

Other

Identifiers

NCT00676377
8771148z

Details and patient eligibility

About

Postoperative ileus (POI) in the absence of any mechanical obstruction remains a commonly encountered clinical problem.So, this study aimed to show the effective way to decrease the rate of postoperative Ileus (POI).

Full description

We honestly declare that, the use of parasympathomimetic agents such as neostigmine is not without risk. Patients with underlying bradyarrhythmias or those receiving β-adrenergic antagonists may be more susceptible to neostigmine-induced bradycardia. Similarly, neostigmine increases airway secretions and bronchial reactivity, which may exacerbate active bronchospasm. Recently, a new class of drugs-peripherally acting mu-opioid receptor antagonists-may help enhance multimodal management of POI. Although, the cost benefit of the new class of drugs is debated. It has been suggested that the individual components of multimodal protocols-for example, laparoscopy-may reduce certain post surgical morbidities (including POI) But do not by them prevent POI. Therefore, combinations of strategies with demonstrated effectiveness-early feeding , epidural analgesia, laparoscopic surgery, and use of peripherally acting mu-opioid-receptor antagonists-may help transform the reactive approach to POI into a proactive multimodal paradigm that effectively targets the diverse etiologic factors leading to this common clinical problem.

Enrollment

3 patients

Sex

All

Ages

18 to 76 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with acute colonic pseudo-obstruction who were 18 years of age or older
  • Patients had to have a cecal diameter of at least 10 cm on plain radiographs
  • Mechanical obstruction was ruled out by the finding of air throughout all colonic segments including the rectosigmoid on plain abdominal radiographs

Exclusion criteria

  • Exclusion criteria included a base-line heart rate of less than 60 beats per minute or systolic blood pressure of less than 90 mm Hg; signs of bowel perforation
  • With peritoneal signs on physical examination or free air on radiographs; active bronchospasm requiring medication
  • Treatment with prokinetic drugs such as cisapride or metoclopramide in the 24 hours before evaluation
  • A history of colon cancer or partial colonic resection
  • Active gastrointestinal bleeding
  • Pregnancy
  • Positive history of Myocardial Infarction, Intestinal Resection or a serum creatinine concentration of more than 3 mg per deciliter (265 µmol per liter)

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

3 participants in 2 patient groups, including a placebo group

1
Experimental group
Description:
Neostigmine
Treatment:
Drug: Neostigmine
2
Placebo Comparator group
Description:
Placebo
Treatment:
Drug: Saline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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