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

Study Overview
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Brief Summary
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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.

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

Conditions
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Conscious Sedation

Intervention / Treatment
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* Drug: Gabapentin
* Other: Standard sedation regimen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard sedation<br>Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care. | Other: Standard sedation regimen<br>* Combination opiate and benzodiazepine will be administered to achieve moderate sedation. This is the standard of care.<br>|
| Active Comparator: Gapabentin<br>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. | Drug: Gabapentin<br>* gabapentin 900mg PO x 1 dose, 1 hour prior to the procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosing Requirements | Assess the effect of a single 900mg dose of gabapentin pre- ERCP on intra and post procedure narcotic/sedative requirements. | At time of discharge post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Sedation-Related Adverse Events | Sedation-related adverse events | At time of discharge post-procedure | 
| Median Pain Score at Time of Discharge | 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). | At time of discharge post-procedure | 
| Median Anxiety Score at Time of Discharge | 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). | At time of discharge post-procedure | 
| Median Nausea Score at Time of Discharge | 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). | At time of discharge post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sedation, Gabapentin, ERCP, Endoscopy