SPICE: Sedation Practices in Intensive Care - A Prospective Randomised Controlled Pilot
The SPICE Pilot Study was a prospective randomised controlled clinical trial. The study was conducted in 8 ICUs in Australia and New Zealand and recruited 60 patients (maximum of 12 patients being recruited from any one site). The pilot study evaluated the feasibility of conducting a large scale multi-centre trial comparing current sedation practice with a dexmedetomidine based sedation regime.
Goal: The main objective of this study was to evaluate the feasibility of recruiting patients soon after commencement of invasive mechanical ventilation and assess the process of delivering dexmedetomidine as a primary sedative agent while avoiding benzodiazepines. The study measured the separation between the intervention group (dex) and control group (usual practice) with respect to administration of sedative and analgesic drugs; evaluate measurement of RASS and CAM-ICU in both groups.
Rationale: Observational studies report an association between administration of the commonly used primary sedative agents, particularly benzodiazepines, and a number of potentially adverse outcomes including increased duration of mechanical ventilation, increased duration of ICU admission, incidence and duration of delirium, and cognitive dysfunction after recovery from critical illness. Dexmedetomidine has been proposed as an alternative to midazolam as a primary sedative agent and may be superior to sedative agents that are in widespread use currently. Therefore, there was a rationale to conduct a phase III randomised controlled trial comparing dexmedetomidine (alpha-2 agonist) based sedation vs standard care sedative agents, with sufficient power to determine if there are differences in patient centred end-points.
Study Progress: Patient recruitment has been completed.
Endorsement: The SPICE Pilot Study was endorsed by the Australian and New Zealand Intensive Care Society Clinical Trials Group (ANZICS-CTG).