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

Indiana University

Status: Completed

Conditions: Conscious Sedation

Treatments: Other: Standard sedation regimen; Drug: Gabapentin

Study type: Interventional

Funder types: Other

Identifiers

NCT01143766

0911-51

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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56 participants in 2 patient groups

Standard sedation

Active Comparator group

Description:

Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.

Treatment:

Other: Standard sedation regimen

Gapabentin

Active Comparator group

Description:

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.

Treatment:

Drug: Gabapentin