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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meperidine and midazolam group | Placebo Comparator | Control. Normal Saline Injections. |
|
| Meperidine and midazolam, plus Diphenhydramine group | Experimental | Diphenhydramine injections given as adjunct sedative. |
|
| Meperidine and midazolam, plus Promethazne group | Experimental | Promethazine given as an adjunct sedative. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meperidine, Midazolam | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Percentage of Sedation Failures | The percentage of participants who could not complete the procedure due inability to achieve proper sedation level | From onset of sedation to completion of procedure, approximately 1 hour. |
| Time to Achieve Adequate Level of Sedation to Begin Procedure | Pre-Endoscopic Procedure (up to 1 hour maximum) | |
| Time for Recovery | Post-Endoscopic Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Symptoms From Sedative Agents | Approximately 3 hours. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Chang, MD | UC Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H.H. Chao Comprehensive Digestive Disease Center | Orange | California | 92868 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 Normal Saline | Control. Normal Saline Injections. |
| FG001 | 2 Diphenhydramine | Diphenhydramine injections given as adjunct sedative. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Diphenhydramine | Drug |
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| Promethazine | Drug |
|
| FG002 | 3 Promethzine | Promethazine given as an adjunct sedative. |
| COMPLETED |
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| NOT COMPLETED |
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We had complete data available on 175 patients. The other patients had incomplete or missing data.
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| ID | Title | Description |
|---|---|---|
| BG000 | 1- Saline Control Group | Control. These patients will receive Normal Saline Injections to serve as controls. Saline: Saline solution injections |
| BG001 | 2 - Diphenhydramine Sedation Group | These patients will receive Diphenhydramine injections given as adjunct sedative. Diphenhydramine: Diphenhydramine injections |
| BG002 | 3 - Promethazine Sedation Group | Promethazine given as an adjunct sedative. Promethazine: Promethazine |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Average Percentage of Sedation Failures | The percentage of participants who could not complete the procedure due inability to achieve proper sedation level | Posted | Mean | Standard Deviation | percentage of participants | From onset of sedation to completion of procedure, approximately 1 hour. |
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| ||||||||||||||||||||||||||||||||
| Primary | Time to Achieve Adequate Level of Sedation to Begin Procedure | Posted | Mean | Standard Deviation | minutes | Pre-Endoscopic Procedure (up to 1 hour maximum) |
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| Primary | Time for Recovery | Posted | Mean | Standard Deviation | minutes | Post-Endoscopic Procedure |
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| Secondary | Adverse Symptoms From Sedative Agents | Posted | Mean | Standard Deviation | adverse events | Approximately 3 hours. |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1 - Control. Normal Saline Injections. | Control. Normal Saline Injections. Saline: Saline solution injections | 0 | 58 | 0 | 58 | ||
| EG001 | 2 - Diphenhydramine Injections Given as Adjunct Sedative. | Diphenhydramine injections given as adjunct sedative. Diphenhydramine: Diphenhydramine injections | 0 | 57 | 0 | 57 | ||
| EG002 | 3 - Promethazine Given as an Adjunct Sedative. | Promethazine given as an adjunct sedative. Promethazine: Promethazine | 0 | 60 | 0 | 60 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kenneth Chang | University of California, Irvine | 714-456-6187 | kchang@uci.edu |
| ID | Term |
|---|---|
| D008614 | Meperidine |
| D008874 | Midazolam |
| D004155 | Diphenhydramine |
| D011398 | Promethazine |
| ID | Term |
|---|---|
| D007540 | Isonipecotic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011437 | Propylamines |
| D010640 | Phenothiazines |
| D013457 | Sulfur Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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