Trial · NCT00937924
Adjunct Sedatives in Endoscopic Ultrasound (EUS) and Endoscopic Retrograde Cholangiopancreatography (ERCP) Procedures
NCT00937924, Phase 4, Completed, University of California, Irvine; results first posted 2024-02-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Adjunct Sedatives in Endoscopic Ultrasound (EUS) and Endoscopic Retrograde Cholangiopancreatography (ERCP) Procedures. Trials, record NCT00937924. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00937924
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Adjunct Sedatives in Endoscopic Ultrasound (EUS) and Endoscopic Retrograde Cholangiopancreatography (ERCP) Procedures
- NCT number
- NCT00937924
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 304 participants, actual
- Lead sponsor
- University of California, Irvine
- Conditions
- Endoscopic Ultrasound (EUS), Endoscopic Retrograde Cholangiopancreatography (ERCP)
- Interventions
- Meperidine, Midazolam, Diphenhydramine, Promethazine
- First posted
- 2009-07-13
- Last updated
- 2024-02-26
- Results first posted
- 2024-02-26
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Average Percentage of Sedation Failures | 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 |
| Primary | Time to Achieve Adequate Level of Sedation to Begin Procedure | Pre-Endoscopic Procedure (up to 1 hour maximum) | |
| Primary | Time for Recovery | Post-Endoscopic Procedure | |
| Secondary | Adverse Symptoms From Sedative Agents | Approximately 3 hours. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Average Percentage of Sedation Failures | From onset of sedation to completion of procedure, approximately 1 hour. | percentage of participants | MEAN | |
| PRIMARY | Time to Achieve Adequate Level of Sedation to Begin Procedure | Pre-Endoscopic Procedure (up to 1 hour maximum) | minutes | MEAN | |
| PRIMARY | Time for Recovery | Post-Endoscopic Procedure | minutes | MEAN | |
| SECONDARY | Adverse Symptoms From Sedative Agents | Approximately 3 hours. | adverse events | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Average Percentage of Sedation Failures | 1 - Control Arm: Normal Saline Injections. | 14 | Standard Deviation 2 | percentage of participants | |
| Average Percentage of Sedation Failures | 2 - Diphenhydramine Injections Given as Adjunct Sedative. | 13 | Standard Deviation 2 | percentage of participants | |
| Average Percentage of Sedation Failures | 3 - Promethazine Given as an Adjunct Sedative. | 5 | Standard Deviation 1 | percentage of participants | |
| Time to Achieve Adequate Level of Sedation to Begin Procedure | 1 - Control. Normal Saline Injections. | 15 | Standard Deviation 3 | minutes | |
| Time to Achieve Adequate Level of Sedation to Begin Procedure | 2 - Diphenhydramine Injections Given as Adjunct Sedative. | 13 | Standard Deviation 4 | minutes | |
| Time to Achieve Adequate Level of Sedation to Begin Procedure | 3 - Promethazine Given as an Adjunct Sedative. | 14 | Standard Deviation 5 | minutes | |
| Time for Recovery | 1 - Control. Normal Saline Injections. | 21.3 | Standard Deviation 5 | minutes | |
| Time for Recovery | 2 - Diphenhydramine Injections Given as Adjunct Sedative. | 29.5 | Standard Deviation 4 | minutes | |
| Time for Recovery | 3 - Promethazine Given as an Adjunct Sedative. | 51.5 | Standard Deviation 6 | minutes | |
| Adverse Symptoms From Sedative Agents | 1 - Control. Normal Saline Injections. | 0 | Standard Deviation 0 | adverse events |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 1 Normal Saline | 102 | |
| Overall Study | STARTED | 2 Diphenhydramine | 101 | |
| Overall Study | STARTED | 3 Promethzine | 101 | |
| Overall Study | COMPLETED | 1 Normal Saline | 58 | |
| Overall Study | COMPLETED | 2 Diphenhydramine | 57 | |
| Overall Study | COMPLETED | 3 Promethzine | 60 | |
| Overall Study | NOT COMPLETED | 1 Normal Saline | 44 | |
| Overall Study | NOT COMPLETED | 2 Diphenhydramine | 44 | |
| Overall Study | NOT COMPLETED | 3 Promethzine | 41 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 1 - Control. Normal Saline Injections. | ||
| Total, all-cause mortality | 2 - Diphenhydramine Injections Given as Adjunct Sedative. | ||
| Total, all-cause mortality | 3 - Promethazine Given as an Adjunct Sedative. | ||
| Total, other adverse events | 1 - Control. Normal Saline Injections. | 0 | 58 |
| Total, other adverse events | 2 - Diphenhydramine Injections Given as Adjunct Sedative. | 0 | 57 |
| Total, other adverse events | 3 - Promethazine Given as an Adjunct Sedative. | 0 | 60 |
| Total, serious adverse events | 1 - Control. Normal Saline Injections. | 0 | 58 |
| Total, serious adverse events | 2 - Diphenhydramine Injections Given as Adjunct Sedative. | 0 | 57 |
| Total, serious adverse events | 3 - Promethazine Given as an Adjunct Sedative. | 0 | 60 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00937924
GET https://conductscience.org/api/trials/v1/NCT00937924/registered