Completed

NCT Number: NCT05707884

Volatiles in Critical Care After Free Flap Surgery

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.

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Key information

Conditions

Sedation Set-up Time Additional Time Required for Volatile Sedation

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

Material consumption

Time frame: 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

Time frame: 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 outcomes

Delir

Time frame: Within the intensive care stay (5 days)

Occurrence of delirium in the intensive care setting
Time to awake

Time frame: Within the intensive care stay (5 days)

Time required beyond the intended 72 hours of sedation for the patient to awaken

Sponsors and collaborators

Lead sponsor

Goethe University

Other

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Feb 1, 2023
Registry last updated: May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.