Diazepam and Blood Pressure Regulation

Early Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Diazepam

• Registration Number: NCT05069779
• Lead Sponsor: University of Brasilia

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2017-08-01
• Primary Completion: 2019-05-20
• Study Completion: 2019-05-20
• Status Verified: 2021-09
• Study First Submitted: 2021-09-15
• Study First Submitted QC: 2021-09-24
• Last Update Submitted: 2021-09-24
• Study First Posted: 2021-10-06
• Last Update Posted: 2021-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Diazepam	Diazepam	Oral
Placebo	Diazepam	Oral

Primary Outcome Measures

Name	Time	Method
Resting beat-to-beat blood pressure variability	Change from baseline at 60 min	Finger photoplethysmography
Systolic and diastolic blood pressure	Change from baseline at 60 min	Oscillometric device

Secondary Outcome Measures

Name	Time	Method
Muscle sympathetic nerve activity	Change from baseline at 60 min	Microneurography
Baroreflex sensitivity	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).

Trial Locations

Locations (1)

University of Brasilia; 🇧🇷 Brasília, DF, Brazil