Sedative Premedication in Coronary Angiography

Study Overview
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Brief Summary
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Evaluation of the possible positive effect of sedative premedication prior to coronary angiography in regards to pain and anxiety.

Detailed Description
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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.

Official Title
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Sedative Premedication in Coronary Angiography

Conditions
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Coronary Angiography, Sedative Premedication

Intervention / Treatment
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* Drug: Alprazolam 0.5 mg
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: elective coronary angiography Exclusion Criteria: planned PCI use of sedative medication at home use of alcohol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: placebo controlled, double blind
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Alprazolam<br>Patients receive alprazolam 0.5 mg 1 hour prior to coronary angiography. | Drug: Alprazolam 0.5 mg<br>* receive alprazolam prior to angio<br>|
| Placebo Comparator: Placebo Oral Tablet<br>Patients receive placebo 1 hour prior to coronary angiography. | Drug: Placebo Oral Tablet<br>* receive placebo prior to angio<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | during procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary angiography, premedication, pain, anxiety