Delirium is a neurocognitive disorder characterised by an acute and temporary decline of mental status affecting attention, awareness, cognition, language and visuospatial ability. The underlying pathophysiology is driven by neuroinflammation and cellular oxidative stress. Delirium is a serious complication following neurosurgical procedures with a reported incidence varying between 4% and 44% and has been associated with increased length of hospital stay, increased amount of reoperations, increased costs and mortality. Perioperative music has been reported to reduce preoperative anxiety, postoperative pain and opioid usage, and attenuates stress response caused by surgery. We hypothesize that this beneficial effect of music on a combination of delirium eliciting factors might reduce delirium incidence following neurosurgery and subsequently improve clinical outcomes.
This protocol concerns a single-centred prospective randomised controlled trial with 6 months follow-up. All adult patients undergoing a craniotomy at the Erasmus Medical Center in Rotterdam are eligible. The music group will receive recorded music through an overear headphone before, during and after surgery until postoperative day 3. Patients can choose from music playlists, offered based on music importance questionnaires administered at baseline. The control group will receive standard of clinical care Delirium is assessed by the Delirium Observation Scale and confirmed by a delirium-expert psychiatrist according to the DSM-5 criteria. Risk factors correlated with the onset of delirium, such as cognitive function at baseline, preoperative anxiety, perioperative medication use, depth of anaesthesia and postoperative pain, and delirium-related health outcomes such as length of stay, daily function, quality of life (ie, EQ-5D, EORTC questionnaires), costs and cost-effectiveness are collected.
Ethics and dissemination:
This study is being conducted in accordance with the Declaration of Helsinki. The Medical Ethics Review Board of Erasmus University Medical Center Rotterdam, The Netherlands, approved this protocol. Results will be disseminated via peer-reviewed scientific journals and conference presentations.
Trial registration numbers:
NL8503 and NCT04649450.
Bibliographical noteFunding Information:
1Neurosurgery, Erasmus Medical Center, Rotterdam, The Netherlands 2Neuroscience, Erasmus MC, Rotterdam, The Netherlands 3Surgery, Erasmus MC, Rotterdam, The Netherlands 4Anesthesiology, Erasmus MC, Rotterdam, The Netherlands 5Department of Psychiatry, Erasmus Medical Center, Rotterdam, The Netherlands 6Pediatric Surgery, Erasmus MC Sophia, Rotterdam, The Netherlands 7Medical Technology Assessment (iMTA), Erasmus Universiteit Rotterdam, Rotterdam, The Netherlands Contributors Each author has contributed significantly to, and is willing to take public responsibility for, one or more aspects of the study. AJPEV, CMFD, JJ and PK conceived the study idea. PK coordinated the research protocol and wrote the first draft of the manuscript. JJ, CMFD, MK, SK, R-JO, MC, MJP and AJPEV critically revised the manuscript. All authors have seen and approved the final version of the manuscript being submitted. The article is the authors’ original work, has not received prior publication and is not under consideration for publication elsewhere. Funding This research is funded with the Erasmus MC Efficiency Grant (Grant number: 19105) by the Erasmus Medical Centre, Rotterdam, The Netherlands. Competing interests None declared.
© Author(s) (or their employer(s)) 2021.