Conscious SedationNCT01143766
Gabapentin to Improve Patient Tolerance in Endoscopic Retrograde Cholangiopancreatography (ERCP)
A study testing Gabapentin and Standard sedation regimen in people with Conscious Sedation, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Conscious Sedation
- What is being tested?
- Gabapentin and Standard sedation regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Dec 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients >18 years of age referred to IUMC for first-time ERCP procedure.
Who cannot join
- Pregnant women
- age <18 years
- Incarcerated individuals
- Patients currently taking or having taken gabapentin or pregabalin within the last 3 months
- Patients unable to give informed consent
- Patients not able to fill out visual analog scales for pain, nausea and anxiety or unable to fill out survey regarding procedural satisfaction.
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- High risk patients for anesthesia: home oxygen, class III or IV heart failure, sleep apnea (on CPAP/BiPAP at home), or ASA class > 3.
- Patients undergoing general anesthesia for their ERCP procedure
- Patients receiving propofol sedation for their ERCP procedure
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospital, Indiana University Purdue University Indianapolis
Indianapolis, Indiana, 46202
About this study
Official title: Premedication With Single Dose Gabapentin to Improve Patient Tolerance in ERCP: A Double-Blind Randomized Controlled Trial
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.
- Conditions
- Conscious Sedation
- Being tested
- Gabapentin, Standard sedation regimen
- Keywords
- Sedation, Gabapentin, ERCP, Endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
gabapentin 900mg PO x 1 dose, 1 hour prior to the procedure
Standard sedation regimenOther
Combination opiate and benzodiazepine will be administered to achieve moderate sedation. This is the standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Standard sedation | Active comparator | Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care. Receives: Other: Standard sedation regimen |
| 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. Receives: Drug: Gabapentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosing Requirements
Assess the effect of a single 900mg dose of gabapentin pre- ERCP on intra and post procedure narcotic/sedative requirements.
Measured: At time of discharge post-procedure
Secondary outcomes (4)
Number of Participants With Sedation-Related Adverse Events
Sedation-related adverse events
Measured: 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).
Measured: 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).
Measured: 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).
Measured: At time of discharge post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Conscious SedationStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregory A. Cote, Indiana University
- Investigators
- Gregory A Cote, MD, MS, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01143766
- Sponsor's protocol ID
- 0911-51
- Status last verified
- Sep 2023
- First submitted
- 11 Jun 2010
- Last updated
- 28 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Premedication With Single Dose Gabapentin to Improve Patient Tolerance in ERCP: A Double-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01143766
- Acronym / sponsor ID
- 0911-51
- Conditions
- Conscious Sedation
- Keywords
- Sedation, Gabapentin, ERCP, Endoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 14 Jun 2010 (estimated)
- Results
- Posted 5 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard sedation | Active comparator | Other: Standard sedation regimenPatients will receive combination opiate and benzodiazepine for sedation, the current standard of care. |
| Gapabentin | Active comparator | Drug: GabapentinPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male or female patients >18 years of age referred to IUMC for first-time ERCP procedure.
Key exclusion criteria (9 listed)
- Pregnant women
- age <18 years
- Incarcerated individuals
- Patients currently taking or having taken gabapentin or pregabalin within the last 3 months
- Patients unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gabapentingabapentin 900mg PO x 1 dose, 1 hour prior to the procedure | Drug | Gapabentin |
| Standard sedation regimenCombination opiate and benzodiazepine will be administered to achieve moderate sedation. This is the standard of care. | Other | Standard sedation |
Primary outcome
Dosing Requirements
Time frame: 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.
4 secondary outcomes
Number of Participants With Sedation-Related Adverse Events
Time frame: At time of discharge post-procedure
Median Pain Score at Time of Discharge
Time frame: At time of discharge post-procedure
Median Anxiety Score at Time of Discharge
Time frame: At time of discharge post-procedure
Median Nausea Score at Time of Discharge
Time frame: At time of discharge post-procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory A Cote, MD, MS principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gabapentin and Standard sedation regimen in people with Conscious Sedation, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dosing Requirements (time frame: At time of discharge post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.