Use of Prokinetics During Inpatient Bowel Care for SCI Patients

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Bowel care (BC) is a time-consuming and cumbersome activity of daily living for most individuals with SCI. Previous studies have reported that the average time to complete a BC routine is 45 minutes; 10-20% of SCI individuals report BC routines lasting for more than 1 hour. In past studies, the investigators have shown that a medication called neostigmine can increase bowel activity and thus, promote bowel movement. The investigators have successfully used this medication with traditional and novel methods of colonoscopic preparations, and have shown that it improves the quality of these preparations. In this study, we would like to test the applicability of this medication to bowel care routines.

The investigators believe that the addition of this medication to the beginning of regular bowel regiments will significantly decrease the time and effort needed to complete BC, thus improving patient perception of their BC routines and quality of life. SCI individuals followed by the James J Peters VA Medical Center (JJPVAMC) SCI Medical Service are admitted on a routine basis for inpatient respite care, therapy, and/or annual physicals. Such inpatient stays typically range in duration from 1 week to 3 weeks, during which the patient undergo BC routines assisted by the inpatient care team. BC routines are typically performed every other day, or thrice weekly (Monday, Wednesday, Friday) in "Blue Rooms" located on the inpatient SCI wards (IE and ID). The bowel care routine, including duration of procedure, use of assistive medications or devices, and completeness of bowel care are documented in the patients' electronic medical chart (CPRS) by care providers. The investigators propose to perform the described protocol in individuals who have been admitted to the hospital for routine care and are otherwise healthy. In doing so, the investigators can ensure that patients are vigilantly monitored during each BC session, and that any changes in BC pattern are accurately observed and documented. Furthermore, by performing these procedures on an inpatient basis, study investigators can ensure the consistency of care and daily routine, allowing for better control of study conditions.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: James J. Peters Veterans Affairs Medical Center
• Treatments: Glycopyrrolate; Neostigmine

Criteria

Inclusion Criteria:

• Age: 18-75 years

• Spinal Cord Injury (SCI):

• greater than 1 year duration

• excess time for bowel evacuation (> 60minutes per session)

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 and/or Bladder

• Myocardial Infarction in the past 6months

• Blood Pressure ≥160/100 mmHg with/without being on 3 or more different classes of antihypertensive medications

• Organ Damage (heart & kidney) and/or transient ischemic attack (TIA)- cerebrovascular accident (CVA) as a result of hypertension

• Known past history of coronary artery disease, chronic heart failure, bradyarrythmia

• Slow Heart Rate (<45bpm)

• Active respiratory diseases

• Known history of asthma during lifetime

• Recent (within 3months) respiratory infections

• Adrenal Insufficiency

• Pregnancy or potential for pregnancy

• Lactating/nursing females

• Use of any antibiotics in past 7days

• Use of medications known to affect respiratory system

• Concurrent participation in other clinical trials (within 30days)