Sedation Set-up TimeNCT05707884
Volatiles in Critical Care After Free Flap Surgery
A study testing critical care management in people with Sedation Set-up Time and Additional Time Required for Volatile Sedation, run by Goethe University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sedation Set-up Time, Additional Time Required for Volatile Sedation
- What is being tested?
- critical care management
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2023to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Free flap surgery
- Patient capable of giving informed written consent
Who cannot join
- Intolerance to volatile anaesthetics (e.g. malignant hyperthermia).
- Severe obstructive pulmonary disease
- Pre-existing severe neurocognitive disorder
- Age <18 years (minors)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Evaluation of Volatile Sedation Management in Critical Care After Free Flap Surgery
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.
- Being tested
- critical care management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
critical care managementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| volatile sedation | Active comparator | Patients receive volatile sedation for the intended 72 hours of deep sedation after complex free flap surgery. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Material consumption
Required equipment and disposable materials related to the treatment interval as well as their monetary value in euros or US dollars.
Measured: 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.
Measured: Inventory of the required time until the end of sedation (90 hours)
Secondary outcomes (2)
Delir
Occurrence of delirium in the intensive care setting
Measured: Within the intensive care stay (5 days)
Time to awake
Time required beyond the intended 72 hours of sedation for the patient to awaken
Measured: Within the intensive care stay (5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start1 Apr 2023
- Primary completion1 Apr 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedation Set-up TimeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Armin N. Flinspach, Goethe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05707884
- Sponsor's protocol ID
- 2022-1040
- Status last verified
- Oct 2023
- First submitted
- 27 Dec 2022
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Volatile Sedation Management in Critical Care After Free Flap Surgery
- ClinicalTrials.gov ID
- NCT05707884
- Acronym / sponsor ID
- 2022-1040
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 1 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| volatile sedation | Active comparator | Other: critical care managementPatients receive volatile sedation for the intended 72 hours of deep sedation after complex free flap surgery. |
| intravenous sedation | No intervention | –Patients receive intravenous sedation (e.g. propofol) for the intended 72 hours of deep sedation after complex free flap surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Free flap surgery
- Patient capable of giving informed written consent
Key exclusion criteria (4 listed)
- Intolerance to volatile anaesthetics (e.g. malignant hyperthermia).
- Severe obstructive pulmonary disease
- Pre-existing severe neurocognitive disorder
- Age <18 years (minors)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| critical care managementThe 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. | Other | volatile sedation |
Primary outcome
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.
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.
2 secondary outcomes
Delir
Time frame: Within the intensive care stay (5 days)
Time to awake
Time frame: Within the intensive care stay (5 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing critical care management in people with Sedation Set-up Time and Additional Time Required for Volatile Sedation, run by Goethe University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Material consumption (time frame: Inventory of the required materials until the end of sedation (90 hours)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.