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

Vertigo, Peripheral Clinical Trial

— Vertigo  

Official title:

Efficacy and Safety of Intravenous Diazepam Given at 2 Different Doses Compared to Placebo in Acute Peripheral Vertigo: A Randomized Controlled Double Blinded Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06293989
• Other study ID #: Emergency department
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 1, 2024
• Est. completion date: March 30, 2026

Study information

• Verified date: April 2024
• Source: University of Monastir
• Contact: NOUIRA Semir, PR
• Phone: 73106000
• Email: semir.nouira[@]rns.tn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: March 30, 2026
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dizziness
• Vertigo
• Vertigo, Peripheral

Intervention

Drug:
• Diazepam 5mg
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.
• Diazepam 10 mg
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.
• Placebo
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Monastir

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	the Delta-VAS	the delta VAS was calculated as [(VAS baseline- VAS3H)/VAS baseline]*100	3 hous
Secondary	the time required to reach the resolution of the vertigo crisis	the time required to reach the resolution of the vertigo crisis	3 hours
Secondary	Patients satisfaction	patient satisfaction with likert scale	3 hours
Secondary	number of patients with adverse effects	number of patients with adverse effects	3 hours