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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2026-03-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Vertigo, Peripheral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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diazepam 5 mg

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.

Group Type EXPERIMENTAL

Diazepam 5mg

Intervention Type 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.

diazepam 10 mg

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.

Group Type EXPERIMENTAL

Diazepam 10 mg

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Placebo

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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diazepam(B) diazepam(C) A

Eligibility Criteria

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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

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No