Sedative Premedication in Coronary Angiography

NCT03576456 | Unknown

• 1 other identifier: awxg2018
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coronary Angiography; Sedative Premedication

Keywords

coronary angiography; premedication; pain; anxiety

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• radial spasm

  during procedure

• vascular site access complication

  during procedure

Study Arms (2)

Alprazolam

ACTIVE COMPARATOR

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

Drug: Alprazolam 0.5 mg

Placebo Oral Tablet

PLACEBO COMPARATOR

Patients receive placebo 1 hour prior to coronary angiography.

Drug: Placebo Oral Tablet

Interventions

Alprazolam 0.5 mg DRUG

receive alprazolam prior to angio

Alprazolam

Placebo Oral Tablet DRUG

receive placebo prior to angio

Placebo Oral Tablet

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elective coronary angiography

You may not qualify if:

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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Adriaan Wilgenhof

Brussels, Jette, 1090, Belgium

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Interventions

Alprazolam

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Danny Schoors, MD PhD

  Head of service

  STUDY DIRECTOR

Central Study Contacts

Adriaan Wilgenhof, MD

CONTACT

003224776009; adriaan.wilgenhof@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Principal Investigator

Model Details: placebo controlled, double blind

Study Record Dates

• First Submitted: June 18, 2018
• First Posted: July 3, 2018
• Study Start: January 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: August 1, 2020
• Last Updated: October 12, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
• Time Frame: within 1 month, during 1 year
• Access Criteria: researcher

Locations

BE (1)