Diazepam and Blood Pressure Regulation

Early Phase 1CompletedNCT05069779

University of Brasilia40 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

DiazepamDRUG

Oral administration of 10 mg of diazepam

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Brasilia

Brasília, Federal District, Brazil

Outcomes

Primary Outcomes

Resting beat-to-beat blood pressure variability

Finger photoplethysmography

Time frame: Change from baseline at 60 min

Systolic and diastolic blood pressure

Oscillometric device

Time frame: Change from baseline at 60 min

Secondary Outcomes

Muscle sympathetic nerve activity

Microneurography

Time frame: Change from baseline at 60 min

Baroreflex sensitivity

The relationship between changes in beat-to-beat blood pressure and heart rate (cardiac baroreflex) or MSNA (sympathetic baroreflex).

Time frame: Change from baseline at 60 min

Data from ClinicalTrials.gov

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