Volatiles in Critical Care After Free Flap Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2025-05-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Sedation Set-up Time Additional Time Required for Volatile Sedation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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volatile sedation

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

Group Type ACTIVE_COMPARATOR

critical care management

Intervention Type 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.

intravenous sedation

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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critical care management

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.

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No