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

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ClinicalTrials.gov Identifier: NCT01143766
Recruitment Status : Completed
First Posted : June 14, 2010
Results First Posted : December 5, 2012
Last Update Posted : January 24, 2018
Sponsor:
Information provided by (Responsible Party):
Gregory A. Cote, Indiana University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition Conscious Sedation
Interventions Drug: Gabapentin
Other: Standard sedation regimen
Enrollment 56
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard Sedation Gapabentin
Hide Arm/Group Description Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care. 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.
Period Title: Overall Study
Started 25 31
Completed 25 31
Not Completed 0 0
Arm/Group Title Standard Sedation Gapabentin Total
Hide Arm/Group Description Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care. 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. Total of all reporting groups
Overall Number of Baseline Participants 25 31 56
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 31 participants 56 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
21
  84.0%
27
  87.1%
48
  85.7%
>=65 years
4
  16.0%
4
  12.9%
8
  14.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 31 participants 56 participants
49.1  (16.6) 48.1  (12.8) 48.6  (14.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 31 participants 56 participants
Female
15
  60.0%
19
  61.3%
34
  60.7%
Male
10
  40.0%
12
  38.7%
22
  39.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 31 participants 56 participants
25 31 56
1.Primary Outcome
Title Dosing Requirements
Hide Description Assess the effect of a single 900mg dose of gabapentin pre- ERCP on intra and post procedure narcotic/sedative requirements.
Time Frame At time of discharge post-procedure
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
TOTAL DOSE OF MEPERIDINE
Arm/Group Title Standard Sedation Gapabentin
Hide Arm/Group Description:
Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.
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.
Overall Number of Participants Analyzed 25 31
Median (Inter-Quartile Range)
Unit of Measure: TOTAL DOSE OF MEPERIDINE, mg
100
(88 to 125)
100
(100 to 150)
2.Secondary Outcome
Title Number of Participants With Sedation-Related Adverse Events
Hide Description Sedation-related adverse events
Time Frame At time of discharge post-procedure
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Sedation Gapabentin
Hide Arm/Group Description:

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

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

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.

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

Overall Number of Participants Analyzed 25 31
Measure Type: Number
Unit of Measure: participants
3 2
3.Secondary Outcome
Title Median Pain Score at Time of Discharge
Hide Description 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).
Time Frame At time of discharge post-procedure
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Sedation Gapabentin
Hide Arm/Group Description:
Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.
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.
Overall Number of Participants Analyzed 25 31
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
80
(39 to 100)
95
(87 to 100)
4.Secondary Outcome
Title Median Anxiety Score at Time of Discharge
Hide Description 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).
Time Frame At time of discharge post-procedure
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Sedation Gapabentin
Hide Arm/Group Description:
Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.
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.
Overall Number of Participants Analyzed 25 31
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
99
(95 to 100)
98
(94 to 100)
5.Secondary Outcome
Title Median Nausea Score at Time of Discharge
Hide Description 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).
Time Frame At time of discharge post-procedure
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Sedation Gapabentin
Hide Arm/Group Description:
Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.
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.
Overall Number of Participants Analyzed 25 31
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
99
(92 to 100)
95
(84 to 100)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard Sedation Gapabentin
Hide Arm/Group Description Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care. 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.
All-Cause Mortality
Standard Sedation Gapabentin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Standard Sedation Gapabentin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/25 (0.00%)      0/31 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Standard Sedation Gapabentin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/25 (12.00%)      4/31 (12.90%)    
Nervous system disorders     
Dizziness   0/25 (0.00%)  2/31 (6.45%)  2
Respiratory, thoracic and mediastinal disorders     
Hypoxemia or apnea   3/25 (12.00%)  3 2/31 (6.45%)  2
Indicates events were collected by 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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Gregory A. Cote
Organization: Indiana University
Phone: 317-944-2740
Responsible Party: Gregory A. Cote, Indiana University
ClinicalTrials.gov Identifier: NCT01143766     History of Changes
Other Study ID Numbers: 0911-51
First Submitted: June 11, 2010
First Posted: June 14, 2010
Results First Submitted: September 20, 2012
Results First Posted: December 5, 2012
Last Update Posted: January 24, 2018