Volatiles in Critical Care After Free Flap Surgery

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05707884

Enrollment

Registered

2023-02-01

Start date

2023-04-01

Completion date

2025-05-01

Last updated

2025-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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.

Interventions

OTHERcritical care management

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Material consumption	Inventory of the required materials until the end of sedation (90 hours)	Required equipment and disposable materials related to the treatment interval as well as their monetary value in euros or US dollars.
Working time expenditure	Inventory of the required time until the end of sedation (90 hours)	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.

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026