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

NCT01143766 | Completed Results

• 1 other identifier: 0911-51
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Conscious Sedation

Keywords

Sedation; Gabapentin; ERCP; Endoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Participants With Sedation-Related Adverse Events

  At time of discharge post-procedure

• Median Pain Score at Time of Discharge

  At time of discharge post-procedure

• Median Anxiety Score at Time of Discharge

  At time of discharge post-procedure

• Median Nausea Score at Time of Discharge

  At time of discharge post-procedure

Study Arms (2)

Standard sedation

ACTIVE COMPARATOR

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

Other: Standard sedation regimen

Gapabentin

ACTIVE COMPARATOR

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

Interventions

Gabapentin DRUG

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

Gapabentin

Standard sedation regimen OTHER

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

Standard sedation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients \>18 years of age referred to IUMC for first-time ERCP procedure.

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

University Hospital, Indiana University Purdue University Indianapolis

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Interventions

Gabapentin

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Limited sample size due to challenges with recruitment and transition to propofol-based anesthesia for sedation in ERCP. Study terminated at 50% enrollment for this reason.

Results Point of Contact

• Title: Gregory A. Cote
• Organization: Indiana University

gcote@iupui.edu

317-944-2740

Study Officials

• Gregory A Cote, MD, MS

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Medicine

Study Record Dates

• First Submitted: June 11, 2010
• First Posted: June 14, 2010
• Study Start: April 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: September 28, 2023
• Results First Posted: December 5, 2012

Record last verified: 2023-09

Locations

US (1)