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

NCT06293989 | Not Yet Recruiting Phase 3

• 1 other identifier: Emergency department
• Study Type: interventional
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Vertigo, Peripheral

Keywords

vertigo; diazepam; placebo

Outcome Measures

Primary Outcomes (1)

• Visual analogue scale (VAS)-3H

  the frequency of vertigo resolution defined as a reduction of at least 50% in VAS at 3-hour(VAS-3H) compared to baseline VAS (VAS baseline) during movement (VAS ambulation).

  3 hours

Secondary Outcomes (4)

• the Delta-VAS

  3 hous

• the time required to reach the resolution of the vertigo crisis

  3 hours

• Patients satisfaction

  3 hours

• number of patients with adverse effects

  3 hours

Study Arms (3)

diazepam 5 mg

EXPERIMENTAL

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.

Drug: Diazepam 5mg

diazepam 10 mg

EXPERIMENTAL

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.

Drug: Diazepam 10 mg

placebo

EXPERIMENTAL

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.

Drug: Placebo

Interventions

Diazepam 5mg DRUG

For the intervention, patients will be randomly allocated into three groups. Each patient will be randomized to one of three treatment groups: diazepam 5 mg (5 mg/1 mL), . 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. The investigators, treating physicians, nurses, and patients were blinded to the treatment.

Also known as: diazepam(B)

diazepam 5 mg

Diazepam 10 mg DRUG

For the intervention, patients will be randomly allocated into three groups. Each patient will be randomized to one of three treatment groups: diazepam10 mg (5 mg/1 mL), . 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. The investigators, treating physicians, nurses, and patients were blinded to the treatment.

Also known as: diazepam(C)

diazepam 10 mg

Placebo DRUG

For the intervention, patients will be randomly allocated into three groups. Each patient will be randomized to one of three treatment groups:Placebo . 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. The investigators, treating physicians, nurses, and patients were blinded to the treatment.

Also known as: A

placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Monastir: lead

MeSH Terms

Conditions

Vertigo

Interventions

Diazepam

Condition Hierarchy (Ancestors)

Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Nouira semir, Pr

  University of Monastir

  STUDY DIRECTOR

Central Study Contacts

NOUIRA Semir, PR

CONTACT

73106000; semir.nouira@rns.tn

GANNOUN IMEN, ARC

CONTACT

73106000; gannounimen@yahoo.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 5, 2024
• Study Start: May 1, 2024
• Primary Completion: December 30, 2025
• Study Completion: March 30, 2026
• Last Updated: April 2, 2024

Record last verified: 2024-04