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NCT05069779 Clinical Trial

Diazepam and Blood Pressure Regulation

Healthy Clinical Trial

Official title:
The Acute Effects of Diazepam on Blood Pressure Regulation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05069779
Other study ID # 70101717.1.0000.5103
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date August 1, 2017
Est. completion date May 20, 2019

Study information
Verified date September 2021
Source University of Brasilia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to determine the acute effects of diazepam on beat-to-beat blood pressure variability and baroreflex control.

Description:

Benzodiazepines are widely prescribed for a variety of clinical conditions. However, its cardiovascular consequences remain controversial. In this study, the investigators sought to determine the acute effects of a single dose of oral diazepam (10mg) on resting beat-to-beat blood pressure variability and cardiac and sympathetic baroreflex sensitivity in a cohort of young, healthy individuals.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date May 20, 2019
Est. primary completion date May 20, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - 18 to 40 years of age - Healthy, free of known cardiovascular, metabolic, or musculoskeletal disease Exclusion Criteria: - History of smoking (tobacco or cannabis), defined as any smoking within the past 3 months - Diagnosed cardiovascular or metabolic disease(s) - Prescription of chronic medications other than oral contraceptives - History of hypertension or presence of arrhythmia

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Diazepam
Oral administration of 10 mg of diazepam

Locations
Country Name City State
Brazil University of Brasilia Brasília DF

Sponsors (1)
Lead Sponsor Collaborator
University of Brasilia

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Resting beat-to-beat blood pressure variability Finger photoplethysmography Change from baseline at 60 min
Primary Systolic and diastolic blood pressure Oscillometric device Change from baseline at 60 min
Secondary Muscle sympathetic nerve activity Microneurography Change from baseline at 60 min
Secondary Baroreflex sensitivity The relationship between changes in beat-to-beat blood pressure and heart rate (cardiac baroreflex) or MSNA (sympathetic baroreflex). Change from baseline at 60 min
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