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

Conscious Sedation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01143766
• Other study ID #: 0911-51
• Status: Completed
• Phase: N/A
• Start date: April 2010
• Est. completion date: December 2011

Study information

• Verified date: September 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Conscious Sedation

Intervention

Drug:
• Gabapentin
gabapentin 900mg PO x 1 dose, 1 hour prior to the procedure

Other:
• Standard sedation regimen
Combination opiate and benzodiazepine will be administered to achieve moderate sedation. This is the standard of care.

Locations

Country	Name	City	State
United States	University Hospital, Indiana University Purdue University Indianapolis	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants With Sedation-Related Adverse Events	Sedation-related adverse events	At time of discharge post-procedure
Secondary	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
Secondary	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
Secondary	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