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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard sedation | Active Comparator | Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin | Drug | gabapentin 900mg PO x 1 dose, 1 hour prior to the procedure |
| |
| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory A Cote, MD, MS | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital, Indiana University Purdue University Indianapolis | Indianapolis | Indiana | 46202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Sedation | Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Sedation | Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Dosing Requirements | Assess the effect of a single 900mg dose of gabapentin pre- ERCP on intra and post procedure narcotic/sedative requirements. | TOTAL DOSE OF MEPERIDINE | Posted | Median | Inter-Quartile Range | TOTAL DOSE OF MEPERIDINE, mg | At time of discharge post-procedure |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Sedation | Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoxemia or apnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gregory A. Cote | Indiana University | 317-944-2740 | gcote@iupui.edu |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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| Standard sedation regimen |
| Other |
Combination opiate and benzodiazepine will be administered to achieve moderate sedation. This is the standard of care. |
|
| 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Number of Participants With Sedation-Related Adverse Events | Sedation-related adverse events | Posted | Number | participants | 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). | Posted | Median | Inter-Quartile Range | units on a scale | 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). | Posted | Median | Inter-Quartile Range | units on a scale | 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). | Posted | Median | Inter-Quartile Range | units on a scale | At time of discharge post-procedure |
|
|
|
| 0 |
| 25 |
| 3 |
| 25 |
| EG001 | 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. | 0 | 31 | 4 | 31 |
| Dizziness | Nervous system disorders | Systematic Assessment |
|
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| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |