Outcome measures
delirium, anxiety, pain, neurological deficit, Delirium, Cancer
POSTOPERATIVE COMPLICATIONS, SECONDARY, PATHOLOGY, DISEASE CHARACTERISTIC, MRS, CANCER
The primary outcome measure was presence or absence of postoperative delirium within the first 5 postoperative days.Secondary outcomes were assessed to substantiate the effects of music on delirium and its clinical implications. Preoperative secondary outcomes (during the 30-minute preoperative holding stay) included anxiety (measured with the Visual Analogue Scale-anxiety/VAS-A) and heart rate variability (HRV), a marker of the autonomic tone reflecting parasympathetic nervous activity, measured with a 30-minute ECG recording. The following HRV parameters were analysed: SD of normal sinus beats, root mean square of successive differences between normal heartbeats (RMSSD), the number of adjacent NN intervals that differ from each other by more than 50 ms and the ratio of low frequency to high frequency power. Intraoperative secondary outcomes included depth of anaesthesia with Bispectral Index (BIS, Aspect V.3.22) with standardised sedation dosages (propofol and remifentanil). BIS was measured from the non-operated side, if feasible with site of resection, and the anaesthesiologist was blinded from the intraoperative BIS values, which was considered ethical as this form of monitoring is not standard of clinical care during intracranial procedures. Postoperative secondary outcomes (measured during the entire postoperative stay) were delirium severity (using the Delirium Rating Scale-revised-98) and delirium duration (onset until first day DOSS score <3), pain (Numerical Rating Scale pain and dosages of analgesic), postoperative complications, length of stay and location of discharge. Finally, patients’ satisfaction of receiving music was assessed with a 100-point VAS (administered at the outpatient clinic 6 weeks after discharge).Baseline characteristics were extracted at baseline from questionnaires or the electronic patient file consisting of age, gender, medical history, daily function (Karnofsky Performance Scale (KPS) or Modified Rankin Scale (MRS)), quality of life (100-Likert scale, EuroQol(EQ)-5D and European Organization for Research and Treatment of Cancer (EORTC) -BN20), cognitive function (Montreal Cognitive Assessment (MoCA)), disease characteristics (ie, neurological deficit, type and side of intracranial pathology) and operation details (ie, emergency grade, duration of surgery).