Sedative Premedication in Coronary Angiography

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

Study Overview

• Status: Unknown
• Conditions: Coronary Angiography; Sedative Premedication
• Intervention / Treatment: Drug: Alprazolam 0.5 mg; Drug: Placebo Oral Tablet

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 Type: Interventional
• Enrollment (Anticipated): 264
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adriaan Wilgenhof, MD; Phone Number: 003224776009; Email: adriaan.wilgenhof@gmail.com

Study Locations

• Belgium
  • Jette
    • Brussels, Jette, Belgium, 1090
      • Adriaan Wilgenhof
      • Contact: Adriaan Wilgenhof, MD; Phone Number: 003224776009; Email: adriaan.wilgenhof@gmail.com
      • Contact: Xavier Galloo, MD; Phone Number: 003224776009

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 97 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• elective coronary angiography

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Alprazolam; Patients receive alprazolam 0.5 mg 1 hour prior to coronary angiography.	Drug: Alprazolam 0.5 mg; receive alprazolam prior to angio
Placebo Comparator: Placebo Oral Tablet; Patients receive placebo 1 hour prior to coronary angiography.	Drug: Placebo Oral Tablet; receive placebo prior to angio

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Investigators: Study Director: Danny Schoors, MD PhD, Head of service

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2019
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: June 18, 2018
• First Submitted That Met QC Criteria: July 2, 2018
• First Posted (Actual): July 3, 2018

Study Record Updates

• Last Update Posted (Actual): October 12, 2018
• Last Update Submitted That Met QC Criteria: October 11, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: pain; anxiety; premedication; coronary angiography
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Alprazolam
• Other Study ID Numbers: awxg2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Time Frame: within 1 month, during 1 year
• IPD Sharing Access Criteria: researcher
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No