Endoscopic Ultrasound (EUS)Phase 4NCT00937924
Adjunct Sedatives in Endoscopic Ultrasound (EUS) and Endoscopic Retrograde Cholangiopancreatography (ERCP) Procedures
A Phase 4 study testing Meperidine, Midazolam, Diphenhydramine and Promethazine in people with Endoscopic Ultrasound (EUS) and Endoscopic Retrograde Cholangiopancreatography (ERCP), run by University of California, Irvine at 1 site in United States.
Trial summary
The purpose of this study is to compare meperidine/midazolam with diphenhydramine, meperidine/midazolam with promethazine, and meperidine/midazolam with placebo as sedation methods. The investigators are interested to see whether adjunct sedatives (diphenhydramine and promethazine) will improve sedation. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Endoscopic Ultrasound (EUS), Endoscopic Retrograde Cholangiopancreatography (ERCP)
- What is being tested?
- Meperidine, Midazolam, Diphenhydramine and Promethazine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 304 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Jun 2012
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing participants between 18 and 75 years of age who present for ERCP or EUS at H.H. Comprehensive Chao Digestive Disease Center.
Who cannot join
- History of allergic or adverse reactions to midazolam, diphenhydramine, or promethazine.
- Acute asthma, narrow angle glaucoma, concurrent use of potent inhibitors of CYP3A4 (amprenavir, atazanavir, or ritonavir), pregnancy, or the inability to consent.
- Patients with conditions that preclude safe conscious sedation will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
H.H. Chao Comprehensive Digestive Disease Center
Orange, California, 92868
About this study
Official title: A Randomized, Double-Blinded, Placebo-Controlled Trial of Promethazine and Diphenhydramine as Adjunct Sedatives for Endoscopic Ultrasound (EUS) and Endoscopic Retrograde Cholangiopancreatography (ERCP)
The purpose of this study is to compare meperidine/midazolam with diphenhydramine, meperidine/midazolam with promethazine, and meperidine/midazolam with placebo as sedation methods. The investigators are interested to see whether adjunct sedatives (diphenhydramine and promethazine) will improve sedation.
Read the detailed description
Comparing sedation techniques during invasive endoscopic procedures such as ERCP and EUS is a relatively unexplored area of clinical research. In particular, the effectiveness of adjunct sedatives such as diphenhydramine and promethazine during ERCP/EUS procedures has not been studied. Achieving a moderate sedation level may be ideal for ERCP/EUS procedures in order to provide adequate patient comfort, amnesia, and completion of intended endoscopic procedures. The relevance of further studies in this area is apparent. In terms of clinical practice; over-sedation can lead to decreased airway protection, longer post-procedural recovery times, and unnecessary drug cost; under-sedation can lead to patient anxiety, agitation, recall, and longer procedural time.
- Being tested
- Meperidine, Midazolam, Diphenhydramine, Promethazine
- Keywords
- EUS, ERCP, Sedation Level, Adverse Symptoms, Recovery time
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meperidine, MidazolamDrug
DiphenhydramineDrug
PromethazineDrug
| Study group | Role | What they receive |
|---|---|---|
| Meperidine and midazolam group | Placebo comparator | Control. Normal Saline Injections. Receives: Drug: Meperidine, Midazolam |
| Meperidine and midazolam, plus Diphenhydramine group | Experimental | Diphenhydramine injections given as adjunct sedative. Receives: Drug: Meperidine, Midazolam; Drug: Diphenhydramine |
| Meperidine and midazolam, plus Promethazne group | Experimental | Promethazine given as an adjunct sedative. Receives: Drug: Meperidine, Midazolam; Drug: Promethazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Percentage of Sedation Failures
The percentage of participants who could not complete the procedure due inability to achieve proper sedation level
Measured: From onset of sedation to completion of procedure, approximately 1 hour.
Time to Achieve Adequate Level of Sedation to Begin Procedure
Measured: Pre-Endoscopic Procedure (up to 1 hour maximum)
Time for Recovery
Measured: Post-Endoscopic Procedure
Secondary outcomes (1)
Adverse Symptoms From Sedative Agents
Measured: Approximately 3 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2009 (estimated)
- Study startFeb 2008
- Primary completionJun 2012
- Study completionJun 2012
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 Endoscopic Ultrasound (EUS)Studies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth J. Chang, University of California, Irvine
- Investigators
- Kenneth Chang, MD, Principal investigator, UC Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00937924
- Sponsor's protocol ID
- 20075810
- Status last verified
- Feb 2024
- First submitted
- 4 Jun 2008
- Last updated
- 26 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blinded, Placebo-Controlled Trial of Promethazine and Diphenhydramine as Adjunct Sedatives for Endoscopic Ultrasound (EUS) and Endoscopic Retrograde Cholangiopancreatography (ERCP)
- ClinicalTrials.gov ID
- NCT00937924
- Acronym / sponsor ID
- 20075810
- Keywords
- EUS, ERCP, Sedation Level, Adverse Symptoms, Recovery time
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 13 Jul 2009 (estimated)
- Results
- Posted 26 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare meperidine/midazolam with diphenhydramine, meperidine/midazolam with promethazine, and meperidine/midazolam with placebo as sedation methods. The investigators are interested to see whether adjunct sedatives (diphenhydramine and promethazine) will improve sedation.
Detailed description
Comparing sedation techniques during invasive endoscopic procedures such as ERCP and EUS is a relatively unexplored area of clinical research. In particular, the effectiveness of adjunct sedatives such as diphenhydramine and promethazine during ERCP/EUS procedures has not been studied. Achieving a moderate sedation level may be ideal for ERCP/EUS procedures in order to provide adequate patient comfort, amnesia, and completion of intended endoscopic procedures. The relevance of further studies in this area is apparent. In terms of clinical practice; over-sedation can lead to decreased airway protection, longer post-procedural recovery times, and unnecessary drug cost; under-sedation can lead to patient anxiety, agitation, recall, and longer procedural time.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Meperidine and midazolam group | Placebo comparator | Drug: Meperidine, MidazolamControl. Normal Saline Injections. |
| Meperidine and midazolam, plus Diphenhydramine group | Experimental | Drug: Meperidine, Midazolam, Drug: DiphenhydramineDiphenhydramine injections given as adjunct sedative. |
| Meperidine and midazolam, plus Promethazne group | Experimental | Drug: Meperidine, Midazolam, Drug: PromethazinePromethazine given as an adjunct sedative. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Willing participants between 18 and 75 years of age who present for ERCP or EUS at H.H. Comprehensive Chao Digestive Disease Center.
Key exclusion criteria (3 listed)
- History of allergic or adverse reactions to midazolam, diphenhydramine, or promethazine.
- Acute asthma, narrow angle glaucoma, concurrent use of potent inhibitors of CYP3A4 (amprenavir, atazanavir, or ritonavir), pregnancy, or the inability to consent.
- Patients with conditions that preclude safe conscious sedation will be excluded.
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 |
|---|---|---|
| Meperidine, Midazolam | Drug | Meperidine and midazolam group, Meperidine and midazolam, plus Diphenhydramine group, Meperidine and midazolam, plus Promethazne group |
| Diphenhydramine | Drug | Meperidine and midazolam, plus Diphenhydramine group |
| Promethazine | Drug | Meperidine and midazolam, plus Promethazne group |
Primary outcome
Average Percentage of Sedation Failures
Time frame: From onset of sedation to completion of procedure, approximately 1 hour.
The percentage of participants who could not complete the procedure due inability to achieve proper sedation level
Time to Achieve Adequate Level of Sedation to Begin Procedure
Time frame: Pre-Endoscopic Procedure (up to 1 hour maximum)
Time for Recovery
Time frame: Post-Endoscopic Procedure
1 secondary outcome
Adverse Symptoms From Sedative Agents
Time frame: Approximately 3 hours.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- 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.
Kenneth Chang, MD principal investigator
UC Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Meperidine, Midazolam, Diphenhydramine and Promethazine in people with Endoscopic Ultrasound (EUS) and Endoscopic Retrograde Cholangiopancreatography (ERCP), run by University of California, Irvine 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 3 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 26 Feb 2024. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Feb 2024). 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?
Average Percentage of Sedation Failures (time frame: From onset of sedation to completion of procedure, approximately 1 hour.). The study lists 3 primary outcomes in all. 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 26 Feb 2024.