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OpenTrials
Completed

NCT Number: NCT01143766

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

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.

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Key information

Conditions

Conscious Sedation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, Indiana University Purdue University Indianapolis

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 > 3.
  • Patients undergoing general anesthesia for their ERCP procedure
  • Patients receiving propofol sedation for their ERCP procedure

Treatment and study plan

Gabapentin

Drug

gabapentin 900mg PO x 1 dose, 1 hour prior to the procedure

Standard sedation regimen

Other

Combination opiate and benzodiazepine will be administered to achieve moderate sedation. This is the standard of care.

Primary outcomes

  1. 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

  1. Number of Participants With Sedation-Related Adverse Events

    Time frame: At time of discharge post-procedure

    Sedation-related adverse events

  2. Median Pain Score at Time of Discharge

    Time frame: At time of discharge post-procedure

    Assess the effect of a single 900mg dose of gabapentin on pain at time of discharge, measured by a visual analog scale ranging from 0 (worst pain) to 100 (no pain).

  3. Median Anxiety Score at Time of Discharge

    Time frame: At time of discharge post-procedure

    Assess the effect of a single 900mg dose of gabapentin on anxiety at time of discharge, measured by a visual analog scale ranging from 0 (worst anxiety) to 100 (no anxiety).

  4. Median Nausea Score at Time of Discharge

    Time frame: At time of discharge post-procedure

    Assess the effect of a single 900mg dose of gabapentin on nausea at time of discharge, measured by a visual analog scale ranging from 0 (worst nausea) to 100 (no nausea).

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 14, 2010
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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