Use of a Prokinetic Agent as an Adjunct to Thrice Weekly Bowel Care After SCI

Launched by JAMES J. PETERS VETERANS AFFAIRS MEDICAL CENTER · Dec 10, 2020

Keywords

ClinConnect Summary

Part 1: IV Screening Twenty subjects with chronic SCI (\>1 year) and difficulty with evacuation (DWE) managed by a regular, thrice weekly bowel care (BC) routines will be recruited for study participation. In order to determine eligibility for the study, the subject will have to undergo an IV screening to test whether or not they are responsive to the drug treatment (neostigmine-glycopyrrolate). Subjects will receive the following dose: 0.03mg/kg neostigmine (NEO) and 0.006mg/kg glycopyrrolate (GLY). If the subject responds (bowel movement) to the IV treatment, they will be allowed to conti...

Gender

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Eligibility criteria

• 1. Inclusion Criteria:
• * Spinal Cord Injury:
• • Level of injury C1 to S4
• • Duration of injury over 1 year
• • Excess time for bowel evacuation (over 60 minutes per bowel training session).
• 2. Exclusion Criteria:
• • Previous Adverse Reaction or Hypersensitivity to Electrical Stimulation
• • Do not require additional bowel care or have "normal bowel function"
• • Known sensitivity to Neostigmine and Glycopyrrolate
• • Blockage in Bowel or Bladder
• • Myocardial Infarction in the past 6months
• • Blood Pressure over 160 over 100 mg Hg with being on 3 or more different classes of antihypertensive medications
• • Organ Damage (heart and kidney) and/or TIA, CVA as a result of hypertension
• • Known past history of coronary artery disease, chronic heart failure, bradyarrythmia
• • Slow Heart Rate (under 45 bpm)
• • Active respiratory diseases
• • Known history of asthma during lifetime
• • Recent (within 3 months) respiratory infections
• • Adrenal Insufficiency
• • Pregnancy or potential for pregnancy
• • Lactating/nursing females
• • Use of any antibiotics in past 7 days
• • Use of medications known to affect respiratory system
• • Concurrent participation in other clinical trials (within 30 days)