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

Not Applicable

Completed

• Conditions: Conscious Sedation
• Interventions: Other: Standard sedation regimen; Drug: Gabapentin

• Registration Number: NCT01143766
• Lead Sponsor: Indiana University

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 available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-06-11
• Study First Submitted QC: 2010-06-11
• Study First Posted: 2010-06-14
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Results First Submitted: 2012-09-20
• Results First Submitted QC: 2012-11-06
• Results First Posted: 2012-12-05
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard sedation	Standard sedation regimen	Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.
Gapabentin	Gabapentin	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.

Primary Outcome Measures

Name	Time	Method
Dosing Requirements	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 Outcome Measures

Name	Time	Method
Number of Participants With Sedation-Related Adverse Events	At time of discharge post-procedure	Sedation-related adverse events
Median Anxiety Score at Time of Discharge	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).
Median Nausea Score at Time of Discharge	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).
Median Pain Score at Time of Discharge	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).

Trial Locations

Locations (1)

University Hospital, Indiana University Purdue University Indianapolis; 🇺🇸 Indianapolis, Indiana, United States