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

• Sponsor: Indiana University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01143766
• Collaborator: (none)
• Enrollment: 56
• Location: 1
• Arms: 2
• Duration (Months): 20
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Conscious Sedation	Drug: Gabapentin; Other: Standard sedation regimen	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Premedication With Single Dose Gabapentin to Improve Patient Tolerance in ERCP: A Double-Blind Randomized Controlled Trial
• Study Start Date: Apr 1, 2010
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard sedation Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.	Other: Standard sedation regimen; Combination opiate and benzodiazepine will be administered to achieve moderate sedation. This is the standard of care.
Active Comparator: 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.	Drug: Gabapentin; gabapentin 900mg PO x 1 dose, 1 hour prior to the procedure

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Number of Participants With Sedation-Related Adverse Events [At time of discharge post-procedure]

   Sedation-related adverse events

2. 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).

3. 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).

4. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital, Indiana University Purdue University Indianapolis	Indianapolis	Indiana	United States	46202

Sponsors and Collaborators

• Indiana University

Investigators

• Principal Investigator: Gregory A Cote, MD, MS, Indiana University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gregory A. Cote, Assistant Professor of Clinical Medicine, Indiana University
• ClinicalTrials.gov Identifier: NCT01143766
• Other Study ID Numbers: 0911-51
• First Posted: Jun 14, 2010
• Last Update Posted: Jan 24, 2018
• Last Verified: Dec 1, 2017

• Keywords provided by Gregory A. Cote, Assistant Professor of Clinical Medicine, Indiana University: Sedation; Gabapentin; ERCP; Endoscopy
• Additional relevant MeSH terms: Gabapentin

Study Results

Participant Flow

Arm/Group Title	Standard Sedation	Gapabentin
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

Baseline Characteristics

Arm/Group Title	Standard Sedation	Gapabentin	Total
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 Participants	25	31	56
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	21 84%	27 87.1%	48 85.7%
>=65 years	4 16%	4 12.9%	8 14.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.1 (16.6)	48.1 (12.8)	48.6 (14.5)
Sex: Female, Male (Count of Participants)
Female	15 60%	19 61.3%	34 60.7%
Male	10 40%	12 38.7%	22 39.3%
Region of Enrollment (participants) [Number]
United States	25 100%	31 100%	56 100%

Outcome Measures

1. Primary Outcome

Title	Dosing Requirements
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

Outcome Measure Data

Analysis Population Description

TOTAL DOSE OF MEPERIDINE

Arm/Group Title	Standard Sedation	Gapabentin
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.
Measure Participants	25	31
Median (Inter-Quartile Range) [TOTAL DOSE OF MEPERIDINE, mg]	100	100

2. Secondary Outcome

Title	Number of Participants With Sedation-Related Adverse Events
Description	Sedation-related adverse events
Time Frame	At time of discharge post-procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Sedation	Gapabentin
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
Measure Participants	25	31
Number [participants]	3 12%	2 6.5%

3. Secondary Outcome

Title	Median Pain Score at Time of Discharge
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Sedation	Gapabentin
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.
Measure Participants	25	31
Median (Inter-Quartile Range) [units on a scale]	80	95

4. Secondary Outcome

Title	Median Anxiety Score at Time of Discharge
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Sedation	Gapabentin
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.
Measure Participants	25	31
Median (Inter-Quartile Range) [units on a scale]	99	98

5. Secondary Outcome

Title	Median Nausea Score at Time of Discharge
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Sedation	Gapabentin
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.
Measure Participants	25	31
Median (Inter-Quartile Range) [units on a scale]	99	95

Adverse Events

Arm/Group Title	Standard Sedation		Gapabentin
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Standard Sedation		Gapabentin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/31 (0%)
Other (Not Including Serious) Adverse Events
	Standard Sedation		Gapabentin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/25 (12%)		4/31 (12.9%)
Nervous system disorders
Dizziness	0/25 (0%)		2/31 (6.5%)	2
Respiratory, thoracic and mediastinal disorders
Hypoxemia or apnea	3/25 (12%)	3	2/31 (6.5%)	2

Limitations/Caveats

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.

More Information

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.