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

NCT01143766 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2023-09-28

Study results available
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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.

Conditions

  • Conscious Sedation

Interventions

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.

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Principal Investigators

  • Gregory A Cote, MD, MS · Indiana University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01143766 on ClinicalTrials.gov