Condition category
Ear, Nose and Throat
Date applied
22/12/2010
Date assigned
31/03/2011
Last edited
12/04/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mario Habek

ORCID ID

Contact details

Department of Neurology
Zagreb Medical School and University Hospital Centre
Kispaticeva 12
Zagreb
HR-10000
Croatia
+385 (0)1 237 6033
mhabek@mef.hr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

VN001

Study information

Scientific title

Intravenous dexamethasone in acute management of vestibular neuronitis: a prospective single centre randomised placebo controlled trial

Acronym

Study hypothesis

Intravenous administration of dexamethasone in combination with vestibular suppressant (diazepam) and antiemetic (thiethylperazine) leads to a quicker recovery of clinical symptoms in patients with vestibular neuronitis (VN) when compared to administration of vestibular suppressant (diazepam) and antiemetic (thiethylperazine).

Ethics approval

University Hospital Centre Zagreb Ethical Committee approved on the 29th November 2010

Study design

Prospective single centre randomised placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Vestibular neuronitis

Intervention

All patients who are diagnosed as VN and have signed informative consent forms will be randomised in one of two groups (A or B):
1. Patients in group A will receive dexamethasone 12 mg intravenous (i.v.), diazepam 10 mg in 500 ml saline and thiethylperazine 10 mg subcutaneously (s.c.)
2. Patients in group B will receive placebo – saline i.v., diazepam 10 mg in 500 ml saline and thiethylperazine 10 mg s.c.

The duration of treatment is one hour in the emergency department. Follow up is 4 hours in the emergency department, and there is follow up visit one month after.

Intervention type

Drug

Phase

Not Applicable

Drug names

Dexamethasone, diazepam, thiethylperazine

Primary outcome measures

Necessity to hospitalise patients who present with VN in the emergency department.

All outcomes will be measured at the admittance to the emergency department and 120 mins after the treatment.

Secondary outcome measures

1. Improvement of nystagmus (grading by Alexander)
2. Improvement of postural instability (grading by Fukuda test)
3. Lessening of nausea (according of visual-analog scale)
4. Lessening of vomiting
5. Recovery of subjective symptoms (according to European Evaluation of Vertigo scale)

All outcomes will be measured at the admittance to the emergency department and 120 mins after the treatment.

Overall trial start date

15/01/2011

Overall trial end date

15/01/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Patients older than 18 years of age (either sex) who will be diagnosed as vestibular neuronitis in the emergency neurology department based on the following criteria:
1. Persistent rotatory vertigo which started up to 48 hours
2. Horisontal-torsional nystagmus, unidirectional, more pronounced on removing fixation
3. Positive head thrust test on the side of vestibular lesion
4. Absence of skew deviation (assessed by Maddox rod test)
5. Normal brain multi-slice computed tomography (MSCT)
6. Normal electrocardiogram (ECG)
7. Normal laboratory findings (complete blood count [CBC], prothrombin time [PT], activated partial thromboplastin time [APTT], blood glucose level, urea, creatinine, aspartate aminotransferase [AST], alanine aminotransferase [ALT], gamma-glutamyl transferase [GGT], creatine kinase [CK], lactate dehydrogenase [LD])

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Loss of hearing
2. Tinnitus
3. Presence of any neurological deficit
4. Medical history containing data of:
4.1. Unregulated arterial hypertension
4.2. Atrial fibrillation
4.3. Diabetes mellitus
5. Patients taking:
5.1. Corticosteroids
5.2. Benzodiazepines
5.3. Patients who have contraindications for taking corticosteroids and benzodiazepines

Recruitment start date

15/01/2011

Recruitment end date

15/01/2013

Locations

Countries of recruitment

Croatia

Trial participating centre

Department of Neurology
Zagreb
HR-10000
Croatia

Sponsor information

Organisation

University Hospital Centre Zagreb (Croatia)

Sponsor details

Department of Neurology
Kispaticeva 12
Zagreb
HR-10000
Croatia

Sponsor type

Hospital/treatment centre

Website

http://www.kbc-zagreb.hr

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospital Centre Zagreb (Croatia) - Department of Neurology

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes