Results
delirium, DM, ’
DISEASE, DIABETES MELLITUS, SECONDARY, HYPERTENSION, MRS
A total of 309 patients were expected to be eligible after screening, of which 189 patients were registered and randomly assigned to the music (n=95) or control group (n=94). Five patients (four in the music group and one in the control group) were excluded after registration due to withdrawing consent (n=1), preoperative use of antipsychotic treatment (n=1) or no craniotomy (n=3, one operation cancelled, one burr-hole biopsy and one no necessity of opening the dura). The remaining 184 patients, constituting the mITT population, were followed up for all the secondary outcomes.The baseline characteristics were similar in the two trial groups (ITT population), with a median age of 60 years and 44% being female (Baseline characteristics*All continuous data are presented in median/IQR.†Somatic history: including systematic disease (DM, hypertension) currently treated by medication and prior surgery (requiring general anaesthesia on the operating room).‡Medication known to induce delirium before admission, such as sleep medication, morphine, atropine and antidepressants.§Reported abusive use of alcohol and/or drugs.¶Patients’ functional performance with the KPS (ranging from 100/’no complaints’ to 0/’death’) and MRS (ranging from 0/’no symptoms to 5/’death’.**Cognitive function assessed with the Montreal Cognitive Assessment.††Electrolyte disturbance (mEq/L) in case of sodium >145 or <135 or potassium <3.5 or >5.‡‡Patients in the mITT population (n=184) only.§§Operation indication within 72 hours.DM, diabetes mellitus; KPS, Karnofsky Performance Scale; mITT, modified intention-to-treat; MRS, Modified Rankin Scale.