Volatiles in Critical Care After Free Flap Surgery

NCT05707884 | Completed

• 1 other identifier: 2022-1040
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 (2)

• Delir

  Within the intensive care stay (5 days)

• Time to awake

  Within the intensive care stay (5 days)

Study Arms (2)

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

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.

volatile sedation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Free flap surgery
• Patient capable of giving informed written consent

You may not qualify if:

• Intolerance to volatile anaesthetics (e.g. malignant hyperthermia).
• Severe obstructive pulmonary disease
• Pre-existing severe neurocognitive disorder
• Age \<18 years (minors)

Sponsors & Collaborators

• Goethe University: lead

Study Sites (1)

University Hospital Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 27, 2022
• First Posted: February 1, 2023
• Study Start: April 1, 2023
• Primary Completion: April 1, 2025
• Study Completion: May 1, 2025
• Last Updated: May 7, 2025

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)