Sedative Premedication in Coronary Angiography

Not Applicable

• Conditions: Sedative Premedication; Coronary Angiography
• Interventions: Drug: Alprazolam 0.5 mg; Drug: Placebo Oral Tablet

• Registration Number: NCT03576456
• Lead Sponsor: Universitair Ziekenhuis Brussel

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.

Study Timeline

• Study First Submitted: 2018-06-18
• Study First Submitted QC: 2018-07-02
• Study First Posted: 2018-07-03
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-11
• Last Update Posted: 2018-10-12
• Study Start: 2019-01-01
• Primary Completion: 2020-01-01
• Study Completion: 2020-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 264

Inclusion Criteria

• elective coronary angiography

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alprazolam	Alprazolam 0.5 mg	Patients receive alprazolam 0.5 mg 1 hour prior to coronary angiography.
Placebo Oral Tablet	Placebo Oral Tablet	Patients receive placebo 1 hour prior to coronary angiography.

Primary Outcome Measures

Name	Time	Method
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).
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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Adriaan Wilgenhof; 🇧🇪 Brussels, Jette, Belgium