Premedication With Single Dose Gabapentin to Improve Patient Tolerance in ERCP: A Double-Blind Randomized Controlled Trial

0911-51

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.

2010-04-01

2011-12-01

2011-12-01

Completed

56

Inclusion Criteria: * Male or female patients \>18 years of age referred to IUMC for first-time ERCP procedure. Exclusion Criteria: 1. Pregnant women 2. age \<18 years 3. Incarcerated individuals 4. Patients currently taking or having taken gabapentin or pregabalin within the last 3 months 5. Patients unable to give informed consent 6. Patients not able to fill out visual analog scales for pain, nausea and anxiety or unable to fill out survey regarding procedural satisfaction. 7. High risk patients for anesthesia: home oxygen, class III or IV heart failure, sleep apnea (on CPAP/BiPAP at home), or ASA class \> 3. 8. Patients undergoing general anesthesia for their ERCP procedure 9. Patients receiving propofol sedation for their ERCP procedure

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 56, 'type': 'ACTUAL'}}

2023-09-28