Volatiles in Critical Care After Free Flap Surgery

Goethe University

Status: Completed

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

Treatments: Other: critical care management

Study type: Interventional

Funder types: Other

Identifiers

NCT05707884

2022-1040

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

volatile sedation

Active Comparator group

Description:

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

Treatment:

Other: critical care management

intravenous sedation

No Intervention group

Description:

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