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
• Status: Completed
• Phase: Early Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Healthy

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