Sedative Premedication in Coronary Angiography

Universitair Ziekenhuis Brussel

Status: Unknown

Conditions: Coronary Angiography; Sedative Premedication

Treatments: Drug: Placebo Oral Tablet; Drug: Alprazolam 0.5 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03576456

awxg2018

Details and patient eligibility

About

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

Full 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.

Enrollment: 264 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• elective coronary angiography

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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264 participants in 2 patient groups, including a placebo group

Alprazolam

Active Comparator group

Description:

Patients receive alprazolam 0.5 mg 1 hour prior to coronary angiography.

Treatment:

Drug: Alprazolam 0.5 mg

Placebo Oral Tablet

Placebo Comparator group

Description:

Patients receive placebo 1 hour prior to coronary angiography.

Treatment:

Drug: Placebo Oral Tablet