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NCT05707884 | Recruiting | Sedation Set-up Time


Volatiles in Critical Care After Free Flap Surgery
Sponsor:

Goethe University

Information provided by (Responsible Party):

Armin N. Flinspach

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.

Condition or disease

Sedation Set-up Time

Additional Time Required for Volatile Sedation

Intervention/treatment

critical care management

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 34 participants
Masking : None (Open Label)
Primary Purpose : Health Services Research
Official Title : Prospective Evaluation of Volatile Sedation Management in Critical Care After Free Flap Surgery
Actual Study Start Date : April 1, 2023
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : July 1, 2026
Arm Intervention/treatment

Active Comparator: volatile sedation

Patients receive volatile sedation for the intended 72 hours of deep sedation after complex free flap surgery.

No Intervention: intravenous sedation

Patients receive intravenous sedation (e.g. propofol) for the intended 72 hours of deep sedation after complex free flap surgery.

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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)

Volatiles in Critical Care After Free Flap Surgery

Location Details


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Volatiles in Critical Care After Free Flap Surgery

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Locations


Recruiting

Germany, Hesse

University Hospital Frankfurt

Frankfurt, Hesse, Germany, 60590

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