Premedication With Single Dose Gabapentin to Improve Patient Tolerance in ERCP: A Double-Blind Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Standard sedation regimen
- Conditions
- Conscious Sedation
- Sponsor
- Indiana University
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Dosing Requirements
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The standard approach to sedation in endoscopic retrograde cholangiopancreatography (ERCP) involves the use of benzodiazepines and opiates to achieve a moderate depth of sedation. There is data to suggest supplementing this regimen with gabapentin may lead to reduced pain, higher patient satisfaction and lower opiate requirements. The investigators are conducting a clinical trial to study this hypothesis.
Investigators
Gregory A. Cote
Assistant Professor of Clinical Medicine
Indiana University
Eligibility Criteria
Inclusion Criteria
- •Male or female patients \>18 years of age referred to IUMC for first-time ERCP procedure.
Exclusion Criteria
- •Pregnant women
- •age \<18 years
- •Incarcerated individuals
- •Patients currently taking or having taken gabapentin or pregabalin within the last 3 months
- •Patients unable to give informed consent
- •Patients not able to fill out visual analog scales for pain, nausea and anxiety or unable to fill out survey regarding procedural satisfaction.
- •High risk patients for anesthesia: home oxygen, class III or IV heart failure, sleep apnea (on CPAP/BiPAP at home), or ASA class \>
- •Patients undergoing general anesthesia for their ERCP procedure
- •Patients receiving propofol sedation for their ERCP procedure
Arms & Interventions
Standard sedation
Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.
Intervention: Standard sedation regimen
Gapabentin
Patients will receive gabapentin 900mg PO x 1 dose, one hour prior to the procedure. At the time of ERCP, patients will be sedated in a standard fashion.
Intervention: Gabapentin
Outcomes
Primary Outcomes
Dosing Requirements
Time Frame: At time of discharge post-procedure
Assess the effect of a single 900mg dose of gabapentin pre- ERCP on intra and post procedure narcotic/sedative requirements.
Secondary Outcomes
- Number of Participants With Sedation-Related Adverse Events(At time of discharge post-procedure)
- Median Anxiety Score at Time of Discharge(At time of discharge post-procedure)
- Median Nausea Score at Time of Discharge(At time of discharge post-procedure)
- Median Pain Score at Time of Discharge(At time of discharge post-procedure)