Sedative Premedication in Coronary Angiography

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03576456

Enrollment

264

Registered

2018-07-03

Start date

2019-01-01

Completion date

2020-08-01

Last updated

2018-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Angiography, Sedative Premedication

Keywords

coronary angiography, premedication, pain, anxiety

Brief summary

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

Detailed description

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.

Interventions

DRUGAlprazolam 0.5 mg

receive alprazolam prior to angio

DRUGPlacebo Oral Tablet

receive placebo prior to angio

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

placebo controlled, double blind

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

Inclusion criteria

* elective coronary angiography

Exclusion criteria

* planned PCI * use of sedative medication at home * use of alcohol

Design outcomes

Primary

Measure	Time frame	Description
preprocedural anxiety: visual analogue scale	Assessed before the coronary angiography	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.
periprocedural pain: visual analogue scale	Assessed after the coronary angiography, within 4 hours.	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).

Secondary

Measure	Time frame	Description
radial spasm	during procedure	spasm of the radial artery as experienced by operator. There is no precise measurement up until today.
vascular site access complication	during procedure	need to switch to femoral access, assessed by the operator.

Countries

Belgium

Contacts

Primary ContactAdriaan Wilgenhof, MD

adriaan.wilgenhof@gmail.com003224776009

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026