Volatiles in Critical Care After Free Flap Surgery

Study Overview
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Brief Summary
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Patients undergoing complex free flap surgery are randomised to volatile or intravenous sedation in terms of subsequent intensive care sedation, based on the in-hospital standard of care. For study purposes, differences in management (set-up times, change of filters, etc.) will be investigated in relation to accelerated awakening and possibly improved neurocognition after the end of sedation.

Official Title
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Prospective Evaluation of Volatile Sedation Management in Critical Care After Free Flap Surgery

Conditions
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Sedation Set-up Time, Additional Time Required for Volatile Sedation

Intervention / Treatment
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* Other: critical care management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Free flap surgery Patient capable of giving informed written consent Exclusion Criteria: Intolerance to volatile anaesthetics (e.g. malignant hyperthermia). Severe obstructive pulmonary disease Pre-existing severe neurocognitive disorder Age <18 years (minors)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: volatile sedation<br>Patients receive volatile sedation for the intended 72 hours of deep sedation after complex free flap surgery. | Other: critical care management<br>* 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.<br>|
| No Intervention: intravenous sedation<br>Patients receive intravenous sedation (e.g. propofol) for the intended 72 hours of deep sedation after complex free flap surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | 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 | Within the intensive care stay (5 days) |