N/A
N=56
Gabapentin to Improve Patient Tolerance in Endoscopic Retrograde Cholangiopancreatography (ERCP)
Conscious Sedation
Bottom Line
View on ClinicalTrials.gov: NCT01143766 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Dec 2012
Primary outcome: Primary: Dosing Requirements — 100; 100 TOTAL DOSE OF MEPERIDINE, mg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Gabapentin (Drug); Standard sedation regimen (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dosing Requirements |
100; 100 | — |
| SECONDARY Number of Participants With Sedation-Related Adverse Events |
3; 2 | — |
| SECONDARY Median Pain Score at Time of Discharge |
80; 95 | — |
| SECONDARY Median Anxiety Score at Time of Discharge |
99; 98 | — |
| SECONDARY Median Nausea Score at Time of Discharge |
99; 95 | — |
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.
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 3.
- Patients undergoing general anesthesia for their ERCP procedure
- Patients receiving propofol sedation for their ERCP procedure
Data sourced from ClinicalTrials.gov (NCT01143766). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.