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Evaluation of the possible positive effect of sedative premedication prior to coronary angiography in regards to pain and anxiety.
Coronary angiography is an invasive procedure that can cause patient discomfort. Sedative premedication before coronary angiography could be used to reduce anxiety and pain, but evidence is lacking. Previous trials were predominantly conducted in men and in coronary interventions with femoral access. Recently, radial access has become the preferred route for performing coronary angiograms (RIVAL trial) In this setting, sedative premedication could be of interest to reduce radial spasms, patient anxiety and pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alprazolam | Active Comparator | Patients receive alprazolam 0.5 mg 1 hour prior to coronary angiography. |
|
| Placebo Oral Tablet | Placebo Comparator | Patients receive placebo 1 hour prior to coronary angiography. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alprazolam 0.5 mg | Drug | receive alprazolam prior to angio |
| |
| Measure | Description | Time Frame |
|---|---|---|
| preprocedural anxiety: visual analogue scale | anxiety prior to coronary angiography. Assessed before the procedure through a visual analogue scale for anxiety (VAS-A). The VAS is a visual scale ranging from 0 to 100 with 0 begin no anxiety at all and 100 begin extreme anxiety. | Assessed before the coronary angiography |
| periprocedural pain: visual analogue scale | pain during to coronary angiography. Assessed after the procedure through a visual analogue scale for pain. The VAS scale is a visual scale ranging from 0 (no pain) to 100 (extreme pain). | Assessed after the coronary angiography, within 4 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| radial spasm | spasm of the radial artery as experienced by operator. There is no precise measurement up until today. | during procedure |
| vascular site access complication | need to switch to femoral access, assessed by the operator. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adriaan Wilgenhof, MD | Contact | 003224776009 | adriaan.wilgenhof@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Danny Schoors, MD PhD | Head of service | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adriaan Wilgenhof | Brussels | Jette | 1090 | Belgium |
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within 1 month, during 1 year
researcher
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| ID | Term |
|---|---|
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000525 | Alprazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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placebo controlled, double blind
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| Placebo Oral Tablet |
| Drug |
receive placebo prior to angio |
|
| during procedure |
| D006571 | Heterocyclic Compounds |