Diazepam and Blood Pressure Regulation

Sponsor
University of Brasilia (Other)
Overall Status
Completed
CT.gov ID
NCT05069779
Collaborator
(none)
40
1
2
21.6
1.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
The Acute Effects of Diazepam on Blood Pressure Regulation
Actual Study Start Date :
Aug 1, 2017
Actual Primary Completion Date :
May 20, 2019
Actual Study Completion Date :
May 20, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Diazepam

Oral

Drug: Diazepam
Oral administration of 10 mg of diazepam

Placebo Comparator: Placebo

Oral

Drug: Diazepam
Oral administration of 10 mg of diazepam

Outcome Measures

Primary Outcome Measures

  1. Resting beat-to-beat blood pressure variability [Change from baseline at 60 min]

    Finger photoplethysmography

  2. Systolic and diastolic blood pressure [Change from baseline at 60 min]

    Oscillometric device

Secondary Outcome Measures

  1. Muscle sympathetic nerve activity [Change from baseline at 60 min]

    Microneurography

  2. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Brasilia Brasília DF Brazil 70910-900

Sponsors and Collaborators

  • University of Brasilia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Brasilia
ClinicalTrials.gov Identifier:
NCT05069779
Other Study ID Numbers:
  • 70101717.1.0000.5103
First Posted:
Oct 6, 2021
Last Update Posted:
Oct 6, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by University of Brasilia
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 6, 2021