Effects of a Standardized Music Intervention on Propofol Requirements and Serum Interleukin-6 and Prolactin in Deeply Sedated Mechanically Ventilated Adults: A Prespecified Secondary Analysis of a Randomized Clinical Trial.

Background/

Objectives

Prolonged exposure to sedative agents in critically ill patients receiving invasive mechanical ventilation (IMV) is associated with adverse clinical outcomes. Music interventions have emerged as a promising non-pharmacological strategy to improve patient comfort and potentially reduce sedative requirements. This prespecified secondary analysis of a randomized controlled trial originally powered to detect differences in cortisol concentrations evaluated the effects of a standardized music intervention on sedative requirements and selected inflammatory and neuroendocrine biomarkers in deeply sedated mechanically ventilated adults.

Methods

An open-label randomized controlled trial involving 110 critically ill adults receiving IMV under deep sedation was conducted. Participants were randomly assigned to a 60-min standardized music intervention delivered through active noise-cancelling headphones or to standard care. Changes in sedative requirements, serum interleukin-6 (IL-6) and prolactin (PRL) concentrations, physiological parameters, and safety outcomes were assessed.

Results

Among participants receiving propofol at the time of the intervention (n = 84), the music intervention group showed a significantly greater reduction in propofol requirements than those receiving standard care (between-group difference 0.079 mg/kg/h, 95% CI 0.008-0.149; p = 0.029). Any reduction in propofol requirements was observed in 46.7% of intervention participants compared with 7.7% of controls. BIS values remained within the target range for deep sedation throughout the intervention period, and no clinically relevant changes were observed in physiological or ventilatory parameters. No significant between-group differences were observed in IL-6 or PRL concentrations after adjustment for baseline values (IL-6: p = 0.606; PRL: p = 0.093). No intervention-related adverse events were reported.

Conclusions

A standardized music intervention was associated with reduced propofol requirements without evidence of a between-group difference in BIS trajectory during the intervention period and without clinically relevant physiological instability in mechanically ventilated critically ill patients. No significant between-group effects were observed on IL-6 or PRL concentrations during the study period. As a prespecified secondary analysis of a trial originally powered for a different primary outcome, these findings should be interpreted in that context and warrant confirmation in future randomized trials specifically designed to evaluate music-related effects on sedative requirements. Future randomized trials incorporating appropriate attention-control conditions are warranted to further clarify the specific effects attributable to the musical stimulus.