Depressie, Manie, Angst, Cognitie, Slaap Psychiatric adverse effects and sleep
Conditions
Interventions
Patients will be randomized to hydrocortisone versus placebo, as add-on to the 
regular dexamethasone scheme peri-operative. Hydrocortisone/placebo will be 
administered orally: 2x 10 mg/day.
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Cranial glioma, meningioma or brain metastasis scheduled to undergo surgery (resection) - Minimal dose of peri-operative cumulative dexamethasone of 24mg or more in 6 days - >=18 years - Good clinical condition; KPS>=70 - Life expectancy >=6 months
Exclusion criteria
Exclusion criteria: - Non-native speakers of Dutch or insufficient command of the Dutch language - Patients that are unable to overview consequences of trial participation - Patients with severe aphasia - Patients that are not able to fill in the questionnaires because of cognitive impairments at the discretion of the physician - Patients with psychiatric diseases or neurological deficits that interfere with the study to the judgement of treating physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary parameter is neuropsychiatric adverse effects measured by the Brief Psychiatric Rating Scale (BPRS). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary parameters are neuropsychiatric adverse effects measured with different questionnaires (Hospital Anxiety and Depression Scale, Altman Self-Rating Mania scale, Positive Affect Negative Affect Scale, Delirium Observation Scale); neurophysiological functioning assessed with different cognitive tests, sleep quality measured with the Leeds Sleep Evaluation Questionnaire (LSEQ) and quality of life with QLQ-C30+BN20. | — |
Countries
Netherlands
Outcome results
None listed