Trial Outcomes & Findings for Gabapentin to Improve Patient Tolerance in Endoscopic Retrograde Cholangiopancreatography (ERCP) (NCT NCT01143766)

NCT ID: NCT01143766

Last Updated: 2023-09-28

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 56 participants
• Primary outcome timeframe: At time of discharge post-procedure
• Results posted on: 2023-09-28

Participant Flow

Participant milestones

Measure	Standard Sedation Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.	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.
Overall Study STARTED	25	31
Overall Study COMPLETED	25	31
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Standard Sedation n=25 Participants Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.	Gapabentin n=31 Participants 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 n=56 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants	27 Participants n=7 Participants	48 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Age, Continuous	49.1 years STANDARD_DEVIATION 16.6 • n=5 Participants	48.1 years STANDARD_DEVIATION 12.8 • n=7 Participants	48.6 years STANDARD_DEVIATION 14.5 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	19 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	31 participants n=7 Participants	56 participants n=5 Participants

PRIMARY outcome

Timeframe: At time of discharge post-procedure

Population: TOTAL DOSE OF MEPERIDINE

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

Outcome measures

Measure	Standard Sedation n=25 Participants Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.	Gapabentin n=31 Participants 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.
Dosing Requirements	100 TOTAL DOSE OF MEPERIDINE, mg Interval 88.0 to 125.0	100 TOTAL DOSE OF MEPERIDINE, mg Interval 100.0 to 150.0

SECONDARY outcome

Timeframe: At time of discharge post-procedure

Sedation-related adverse events

Outcome measures

Measure	Standard Sedation n=25 Participants Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.	Gapabentin n=31 Participants 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.
Number of Participants With Sedation-Related Adverse Events	3 participants	2 participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Standard Sedation n=25 Participants Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.	Gapabentin n=31 Participants 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.
Median Pain Score at Time of Discharge	80 units on a scale Interval 39.0 to 100.0	95 units on a scale Interval 87.0 to 100.0

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Standard Sedation n=25 Participants Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.	Gapabentin n=31 Participants 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.
Median Anxiety Score at Time of Discharge	99 units on a scale Interval 95.0 to 100.0	98 units on a scale Interval 94.0 to 100.0

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Standard Sedation n=25 Participants Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.	Gapabentin n=31 Participants 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.
Median Nausea Score at Time of Discharge	99 units on a scale Interval 92.0 to 100.0	95 units on a scale Interval 84.0 to 100.0

Adverse Events

Standard Sedation

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Gapabentin

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Standard Sedation n=25 participants at risk Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.	Gapabentin n=31 participants at risk 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.
Respiratory, thoracic and mediastinal disorders Hypoxemia or apnea	12.0% 3/25 • Number of events 3	6.5% 2/31 • Number of events 2
Nervous system disorders Dizziness	0.00% 0/25	6.5% 2/31 • Number of events 2

Additional Information

Gregory A. Cote

Indiana University

Phone: 317-944-2740

Email: gcote@iupui.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place