Volatiles in Critical Care After Free Flap Surgery | NCT05707884 | Trialant

Volatiles in Critical Care After Free Flap Surgery | NCT05707884 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
volatile sedation	Active Comparator	Patients receive volatile sedation for the intended 72 hours of deep sedation after complex free flap surgery.	Other: critical care management
intravenous sedation	No Intervention	Patients receive intravenous sedation (e.g. propofol) for the intended 72 hours of deep sedation after complex free flap surgery.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
critical care management	Other	The different sedation methods result in considerable differences in terms of set-up costs and the management of the patient, which will be examined in a direct comparison.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Material consumption	Required equipment and disposable materials related to the treatment interval as well as their monetary value in euros or US dollars.	Inventory of the required materials until the end of sedation (90 hours)
Working time expenditure	Time spent by nurses or physicians on the specific sedation procedure, as well as the corresponding financial value based on nationally applicable collective wage agreements in euros or US dollars.	Inventory of the required time until the end of sedation (90 hours)

Secondary Outcomes

Measure	Description	Time Frame
Delir	Occurrence of delirium in the intensive care setting	Within the intensive care stay (5 days)
Time to awake	Time required beyond the intended 72 hours of sedation for the patient to awaken