Intravenous dexamethasone in acute management of vestibular neuronitis
| ISRCTN | ISRCTN84838161 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84838161 |
| Secondary identifying numbers | VN001 |
- Submission date
- 22/12/2010
- Registration date
- 31/03/2011
- Last edited
- 18/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Mario Habek
Scientific
Scientific
Department of Neurology
Zagreb Medical School and University Hospital Centre
Kispaticeva 12
Zagreb
HR-10000
Croatia
| Phone | +385 (0)1 237 6033 |
|---|---|
| mhabek@mef.hr |
Study information
| Study design | Prospective single centre randomised placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Intravenous dexamethasone in acute management of vestibular neuronitis: a prospective single centre randomised placebo controlled trial |
| Study objectives | 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(s) | University Hospital Centre Zagreb Ethical Committee approved on the 29th November 2010 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Dexamethasone, diazepam, thiethylperazine |
| Primary outcome measure | 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 study start date | 15/01/2011 |
| Completion date | 15/01/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Key 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]) |
| Key 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 |
| Date of first enrolment | 15/01/2011 |
| Date of final enrolment | 15/01/2013 |
Locations
Countries of recruitment
- Croatia
Study participating centre
Department of Neurology
Zagreb
HR-10000
Croatia
HR-10000
Croatia
Sponsor information
University Hospital Centre Zagreb (Croatia)
Hospital/treatment centre
Hospital/treatment centre
Department of Neurology
Kispaticeva 12
Zagreb
HR-10000
Croatia
| Website | http://www.kbc-zagreb.hr |
|---|---|
"ROR" |
https://ror.org/00r9vb833 |
Funders
Funder type
Hospital/treatment centre
University Hospital Centre Zagreb (Croatia) - Department of Neurology
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2016 | 18/01/2019 | Yes | No |
Editorial Notes
18/01/2019: Publication reference added
