Gabapentin to Improve Patient Tolerance in Endoscopic Retrograde Cholangiopancreatography (ERCP) | RxWiki

Gabapentin to Improve Patient Tolerance in Endoscopic Retrograde Cholangiopancreatography (ERCP)

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Conscious Sedation
Intervention	Drug: Gabapentin Other: Standard sedation regimen
Phase	N/A
Sponsor	Indiana University
Responsible Party	Indiana University
ClinicalTrials.gov Identifier	NCT01143766
First Received	June 11, 2010
Last Updated	November 6, 2012
Last verified	November 2012

Tracking Information[ + expand ][ + ]

First Received Date	June 11, 2010
Last Updated Date	November 6, 2012
Start Date	April 2010
Estimated Primary Completion Date	December 2011
Current Primary Outcome Measures	Dosing Requirements [Time Frame: At time of discharge post-procedure] [Designated as safety issue: No]Assess the effect of a single 900mg dose of gabapentin pre- ERCP on intra and post procedure narcotic/sedative requirements.
Current Secondary Outcome Measures	Safety [Time Frame: At time of discharge post-procedure] [Designated as safety issue: Yes]Measure sedation-related adverse events Efficacy [Time Frame: At time of discharge post-procedure] [Designated as safety issue: No]Assess the effect of a single 900mg dose of gabapentin pre-ERCP on pre and post procedure pain, anxiety and nausea as reported on visual analog scales.

Descriptive Information[ + expand ][ + ]

Brief Title	Gabapentin to Improve Patient Tolerance in Endoscopic Retrograde Cholangiopancreatography (ERCP)
Official Title	Premedication With Single Dose Gabapentin to Improve Patient Tolerance in ERCP: A Double-Blind Randomized Controlled Trial
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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	N/A
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Condition	Conscious Sedation
Intervention	Drug: Gabapentin gabapentin 900mg PO x 1 dose, 1 hour prior to the procedure Other: Standard sedation regimen Combination opiate and benzodiazepine will be administered to achieve moderate sedation. This is the standard of care.
Study Arm (s)	Active Comparator: Standard sedation Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care. Active Comparator: 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.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	56
Estimated Completion Date	December 2011
Estimated Primary Completion Date	December 2011
Eligibility Criteria	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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT01143766
Other Study ID Numbers	0911-51
Has Data Monitoring Committee	No
Information Provided By	Indiana University
Study Sponsor	Indiana University
Collaborators	Not Provided
Investigators	Principal Investigator: Gregory A Cote, MD, MS Indiana University
Verification Date	November 2012

Locations[ + expand ][ + ]