## Protocol Section
### Identification Module
**NCT ID:** NCT05069779

**Brief Title:** Diazepam and Blood Pressure Regulation

**Official Title:** The Acute Effects of Diazepam on Blood Pressure Regulation

#### Organization Study ID Info
**ID:** 70101717.1.0000.5103
#### Organization
**Class:** OTHER
**Full Name:** University of Brasilia
### Status Module
#### Completion Date
**Date:** 2019-05-20

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-10-06

**Type:** ACTUAL

**Last Update Submit Date:** 2021-09-24

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-05-20

**Type:** ACTUAL

#### Start Date
**Date:** 2017-08-01

**Type:** ACTUAL

**Status Verified Date:** 2021-09

#### Study First Post Date
**Date:** 2021-10-06
**Type:** ACTUAL
**Study First Submit Date:** 2021-09-15
**Study First Submit QC Date:** 2021-09-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Brasilia

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Is US Export:** True

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Healthy

**Keywords:**

- Blood pressure

- Benzodiazepine

- Autonomic nervous system

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 40

**Type:** ACTUAL

**Phases:**

- EARLY_PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Oral

**Intervention Names:**

- Drug: Diazepam

**Label:** Diazepam

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Oral

**Intervention Names:**

- Drug: Diazepam

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Diazepam

- Placebo

**Description:** Oral administration of 10 mg of diazepam

**Name:** Diazepam

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Finger photoplethysmography

**Measure:** Resting beat-to-beat blood pressure variability

**Time Frame:** Change from baseline at 60 min

**Description:** Oscillometric device

**Measure:** Systolic and diastolic blood pressure

**Time Frame:** Change from baseline at 60 min

#### Secondary Outcomes

**Description:** Microneurography

**Measure:** Muscle sympathetic nerve activity

**Time Frame:** Change from baseline at 60 min

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

**Measure:** Baroreflex sensitivity

**Time Frame:** Change from baseline at 60 min

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Maximum Age:** 40 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Brasília

**Country:** Brazil

**Facility:** University of Brasilia

**State:** DF

**Zip:** 70910-900

### IPD Sharing Statement Module

**Description:** The data underlying this project will be shared on reasonable request to the principal investigator.

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

- CSR

**IPD Sharing:** YES

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: Rare

- Name: Rare Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Ancestors

- ID: D000000759

- Term: Adjuvants, Anesthesia

- ID: D000000927

- Term: Anticonvulsants

- ID: D000000932

- Term: Antiemetics

- ID: D000001337

- Term: Autonomic Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000005765

- Term: Gastrointestinal Agents

- ID: D000006993

- Term: Hypnotics and Sedatives

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000009125

- Term: Muscle Relaxants, Central

- ID: D000009465

- Term: Neuromuscular Agents

- ID: D000014151

- Term: Anti-Anxiety Agents

- ID: D000014149

- Term: Tranquilizing Agents

- ID: D000011619

- Term: Psychotropic Drugs

- ID: D000018686

- Term: Anesthetics, Intravenous

- ID: D000018681

- Term: Anesthetics, General

- ID: D000000777

- Term: Anesthetics

- ID: D000018757

- Term: GABA Modulators

- ID: D000018682

- Term: GABA Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: AdjAn

- Name: Adjuvants, Anesthesia

- Abbrev: AntiConv

- Name: Anticonvulsants

- Abbrev: AnEm

- Name: Antiemetics

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: MuRelCen

- Name: Muscle Relaxants, Central

- Abbrev: PsychDr

- Name: Psychotropic Drugs

- Abbrev: Gast

- Name: Gastrointestinal Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M7167

- Name: Diazepam

- Relevance: HIGH

- As Found: ALA

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M4089

- Name: Adjuvants, Anesthesia

- Relevance: LOW

- As Found: Unknown

- ID: M4246

- Name: Anticonvulsants

- Relevance: LOW

- As Found: Unknown

- ID: M4251

- Name: Antiemetics

- Relevance: LOW

- As Found: Unknown

- ID: M8881

- Name: Gastrointestinal Agents

- Relevance: LOW

- As Found: Unknown

- ID: M10043

- Name: Hypnotics and Sedatives

- Relevance: LOW

- As Found: Unknown

- ID: M16905

- Name: Anti-Anxiety Agents

- Relevance: LOW

- As Found: Unknown

- ID: M14474

- Name: Psychotropic Drugs

- Relevance: LOW

- As Found: Unknown

- ID: M20766

- Name: Anesthetics, Intravenous

- Relevance: LOW

- As Found: Unknown

- ID: M20761

- Name: Anesthetics, General

- Relevance: LOW

- As Found: Unknown

- ID: M20827

- Name: GABA Modulators

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000003975

- Term: Diazepam

### Misc Info Module

- Version Holder: 2024-05-24
