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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01143766

Enrollment

Registered

2010-06-14

Start date

2010-04-30

Completion date

2011-12-31

Last updated

2023-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Conscious Sedation

Keywords

Sedation, Gabapentin, ERCP, Endoscopy

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.

Interventions

DRUGGabapentin

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

OTHERStandard sedation regimen

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Number of Participants With Sedation-Related Adverse Events	At time of discharge post-procedure	Sedation-related adverse events
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).
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).

Countries

United States

Participant flow

Participants by arm

Arm	Count
Standard Sedation Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.	25
Gapabentin 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.	31
Total	56

Baseline characteristics

Characteristic	Total	Standard Sedation	Gapabentin
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	8 Participants	4 Participants	4 Participants
Age, Categorical Between 18 and 65 years	48 Participants	21 Participants	27 Participants
Age, Continuous	48.6 years STANDARD_DEVIATION 14.5	49.1 years STANDARD_DEVIATION 16.6	48.1 years STANDARD_DEVIATION 12.8
Region of Enrollment United States	56 participants	25 participants	31 participants
Sex: Female, Male Female	34 Participants	15 Participants	19 Participants
Sex: Female, Male Male	22 Participants	10 Participants	12 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	3 / 25	4 / 31
serious Total, serious adverse events	0 / 25	0 / 31

Outcome results

Primary

Dosing Requirements

Assess the effect of a single 900mg dose of gabapentin pre- ERCP on intra and post procedure narcotic/sedative requirements.