Efficacy and Safety of Intravenous Diazepam Given at 2 Different Doses Compared to Placebo in Acute Peripheral Vertigo

University of Monastir

Status and phase: Not yet enrolling; Phase 3

Conditions: Vertigo, Peripheral

Treatments: Drug: Diazepam 5mg; Drug: Placebo; Drug: Diazepam 10 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT06293989

Emergency department

Details and patient eligibility

About

This is prospective, randomised double-blind study that will be conducted in the emergency department of 3 university hospitals (FB Monastir, Sahloul Sousse, and FH Sousse) to compare the efficacy of two doses of diazepam (Valium®) and placebo for the relief of acute periphery vertigo in the ED

Full description

This is prospective, randomised double-blind study that will be conducted in the emergency department of 3 university hospitals (FB Monastir, Sahloul Sousse, and FH Sousse) to compare the efficacy of two doses of diazepam (Valium®) and placebo for the relief of acute periphery vertigo in the ED. The study should be reviewed and receive approval from the institutional review board. Principles of the Helsinki Declaration are considered All patients should provide their informed consent prior to enrollment.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria;

• patients between 18 and 70 years of age
• a chief complaint of acute peripheral vertigo (APV) (sensation of spinning, which was worsened by movement and sudden in onset) were eligible if the treating emergency physician diagnosed an episode of vertigo that was peripheral in nature.

Exclusion Criteria: -Patients aged > 70 years as central vertigo , -patients with a focal neurologic deficit, pregnancy, history of allergic reaction or contraindication to any of the test drugs, history of enrolment in a previous clinical drug trial,

• history of recent ingestion (within 24 hours) of a sedative, antihistamine, antipsychotic, or opioid,
• history of syncope or cardiac event, considerations of a central origin for vertigo -evidence of drug-induced vertigo or orthostatic hypotension -history of mental or neurological illness.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,000 participants in 3 patient groups

diazepam 5 mg

Experimental group

Description:

Medications will be diluted with 5 mL of normal saline solution slowly intravenously injected (over 5 minutes). The associate clinical research coordinator was responsible for preparation and dispensing the study drug.

Treatment:

Drug: Diazepam 5mg

diazepam 10 mg

Experimental group

Description:

Medications will be diluted with 5 mL of normal saline solution slowly intravenously injected (over 5 minutes). The associate clinical research coordinator was responsible for preparation and dispensing the study drug.

Treatment:

Drug: Diazepam 10 mg

placebo

Experimental group

Description:

Medications will be diluted with 5 mL of normal saline solution slowly intravenously injected (over 5 minutes). The associate clinical research coordinator was responsible for preparation and dispensing the study drug.

Treatment:

Drug: Placebo