An interventional study of Alprazolam 0.5 mg and Placebo Oral Tablet in Coronary Angiography and Sedative Premedication, sponsored by Universitair Ziekenhuis Brussel. Status unknown at 1 site in Belgium. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2018-10-12.
Sponsored by Universitair Ziekenhuis Brussel · Not applicable, Interventional, and Treatment
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.
Universitair Ziekenhuis Brussel is the lead sponsor of 362 studies on the registry; 103 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients receive alprazolam 0.5 mg 1 hour prior to coronary angiography.
Drug: Alprazolam 0.5 mg
Patients receive placebo 1 hour prior to coronary angiography.
Drug: Placebo Oral Tablet
receive alprazolam prior to angio
receive placebo prior to angio
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.
Time frame: 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).
Time frame: Assessed after the coronary angiography, within 4 hours.
radial spasm
spasm of the radial artery as experienced by operator. There is no precise measurement up until today.
Time frame: during procedure
vascular site access complication
need to switch to femoral access, assessed by the operator.
Time frame: during procedure
Plan to share: Yes
Supporting information: Study protocol, Icf, Csr, Analytic code
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Universitair Ziekenhuis Brussel