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Clinical Trials/NCT05707884
NCT05707884
Completed
Not Applicable

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

Goethe University1 site in 1 country34 target enrollmentApril 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sedation Set-up Time
Sponsor
Goethe University
Enrollment
34
Locations
1
Primary Endpoint
Working time expenditure
Status
Completed
Last Updated
12 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2023
End Date
May 1, 2025
Last Updated
12 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Goethe University
Responsible Party
Principal Investigator
Principal Investigator

Armin N. Flinspach

Principal Investigator

Goethe University

Eligibility Criteria

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)

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • Time to awake(Within the intensive care stay (5 days))
  • Delir(Within the intensive care stay (5 days))

Study Sites (1)

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