Volatiles in Critical Care After Free Flap Surgery

Not Applicable

Completed

• Conditions: Sedation Set-up Time; Additional Time Required for Volatile Sedation
• Interventions: Other: critical care management

• Registration Number: NCT05707884
• Lead Sponsor: Goethe University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-27
• Study First Submitted QC: 2023-01-22
• Study First Posted: 2023-02-01
• Study Start: 2023-04-01
• Status Verified: 2023-10
• Primary Completion: 2025-04-01
• Study Completion: 2025-05-01
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
volatile sedation	critical care management	Patients receive volatile sedation for the intended 72 hours of deep sedation after complex free flap surgery.

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Frankfurt; 🇩🇪 Frankfurt, Hessen, Germany