Sedative Premedication in Coronary Angiography

Coronary Angiography Clinical Trial

Official title:

Sedative Premedication in Coronary Angiography

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03576456
• Other study ID #: awxg2018
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: August 1, 2020

Study information

• Verified date: October 2018
• Source: Universitair Ziekenhuis Brussel
• Contact: Adriaan Wilgenhof, MD
• Phone: 003224776009
• Email: adriaan.wilgenhof[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 264
• Est. completion date: August 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• elective coronary angiography

Exclusion Criteria:

• planned PCI

• use of sedative medication at home

• use of alcohol

Related Conditions & MeSH terms

• Coronary Angiography
• Sedative Premedication

Intervention

Drug:
• Alprazolam 0.5 mg
receive alprazolam prior to angio
• Placebo Oral Tablet
receive placebo prior to angio

Locations

Country	Name	City	State
Belgium	Adriaan Wilgenhof	Brussels	Jette

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

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