MusiC to prevent deliriUm during neuroSurgerY

Conditions: Delirium.

Registration Number: NL-OMON22786

Lead Sponsor: Erasmus MC Doelmatigheid 2019

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 189

Inclusion Criteria

1. Patients undergoing a craniotomy.
2. Adult patients (cq age =18 years)
3. Sufficient knowledge of the Dutch language to understand the study documents in the judgement of the attending physician or researcher.
4. Provision of written informed consent by patient or legal representative.

Exclusion Criteria

1. Impaired awareness before surgery (i.e. GCS < M6).
2. Planned post-operative ICU admission.
3. Suspected delirium (defined as fluctuating awareness).
4. Current antipsychotic treatment.
5. Patients undergoing interventions impeding supply of music (e.g. surgical translabyrinthine approach, awake surgery).
6. Severe bilateral hearing impairment, defined as no verbal communication possible.
7. Current participation in other clinical trials interfering with results.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure is presence or absence of postoperative delirium within the first 5 days after surgery. <br><br>All participating patients on the ward will be screened using the Delirium Observation Screening (DOS) scale. Additional to the DOS, in case of raised suspicion of delirium, a psychiatrist is consulted to confirm or reject clinical diagnosis of delirium based on the DSM-V criteria.

Secondary Outcome Measures

Name	Time	Method
- Severity and duration of delirium.<br>- Pre-operative anxiety.<br>- Activation of the parasympathetic nervous system measured with HRV.<br>- Depth of anaesthesia registered with Bispectral Index (BIS). <br>- Peri-operative medication use.<br>- Postoperative pain.<br>- Postoperative complications.<br>- Hospital length of stay in days. <br>- Cognitive function. <br>- Daily function, expressed in Karnofsky Perfomance Scale (KPS) and Modified<br> Ranking Scale (mRS).<br>- Mortality and readmission rate.<br>- Health-related quality of life<br>- Patient satisfaction. <br>- Economic evaluation. An evaluation of the costs and cost-effectiveness of the intervention<br> will be made. See section 10.3.