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Completed

NCT Number: NCT05069779

Diazepam and Blood Pressure Regulation

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

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Brasilia

Brasília, Federal District, 70910-900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diazepam

Drug

Oral administration of 10 mg of diazepam

Primary outcomes

  1. Resting beat-to-beat blood pressure variability

    Time frame: Change from baseline at 60 min

    Finger photoplethysmography

  2. Systolic and diastolic blood pressure

    Time frame: Change from baseline at 60 min

    Oscillometric device

Secondary outcomes

  1. Muscle sympathetic nerve activity

    Time frame: Change from baseline at 60 min

    Microneurography

  2. Baroreflex sensitivity

    Time frame: Change from baseline at 60 min

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

Sponsors and collaborators

Lead sponsor

University of Brasilia

Other

Registry information

Official study title

The Acute Effects of Diazepam on Blood Pressure Regulation

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 6, 2021
Registry last updated
Oct 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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