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Cardiac surgery is a complex operative procedure with a substantial risk of postoperative complications, so that patients undergoing valve surgery are usually transferred to the intensive care unit postoperatively. Various substances are used to maintain the required sedation, such as volatile anaesthetics and intravenous sedatives combined with analgetic therapy using opioids.
The study intends to investigate to what extent the already well-described effect of volatile anaesthetics on recovery can be realised despite the need for differentiated intensive care and medical management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Volatile procedere | Active Comparator | Intensive care treatment with demand-adapted sedation with volatile anaesthetics |
|
| Conventional procedere | No Intervention | Conventional Intensive care treatment with demand-adapted sedation with intravenous sedatives |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Post-operative intensive care using volatile sedation | Other | Patients admitted after valve surgery are receiving intensive care using volatile sedative per anaesthetic conserving device. The subject of the study is medical and nursing time management.. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to extubation | Time from admission on ICU until awakening and Extubation. | through study completion, an average of 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to neurocognitive assessability | Time from admission on ICU until awake and neurocognitive assessable. | through study completion, an average of 2 days |
| Required setup time of the intensive care workplace |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Armin N Flinspach, M.D. | JWGoethe University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Frankfurt | Frankfurt am Main | Hesse | 60590 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38581030 | Derived | Flinspach AN, Raimann FJ, Kaiser P, Pfaff M, Zacharowski K, Neef V, Adam EH. Volatile versus propofol sedation after cardiac valve surgery: a single-center prospective randomized controlled trial. Crit Care. 2024 Apr 5;28(1):111. doi: 10.1186/s13054-024-04899-y. | |
| 35197356 | Derived | Flinspach AN, Herrmann E, Raimann FJ, Zacharowski K, Adam EH. Evaluation of volatile sedation in the postoperative intensive care of patients recovering from heart valve surgery: protocol for a randomised, controlled, monocentre trial. BMJ Open. 2022 Feb 23;12(2):e057804. doi: 10.1136/bmjopen-2021-057804. |
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| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
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Required setup time of the intensive care workplace to provide volatile or intravenous sedation.
| through study completion, up to 24 hours |
| Factor related to the course of intensive care: blood loss | Measured Postoperative Blood Loss | through study completion, an average of 24 hours |
| Factor related to the course of intensive care: kidney injury | Measured increases in serum renal retention levels: creatinine and urea in terms of renal failure according to Kidney Disease - Improving Global Outcomes (KDIGO) criteria. | through study completion, an average of 24 hours |
| Factor related to the course of intensive care: acid-base balance | Measured serum lactate levels and hypercapnia | through study completion, an average of 24 hours |
| Factor related to the course of intensive care: lung function parameters | Required inspiratory oxygen fraction | through study completion, an average of 24 hours |
| Factor related to the course of intensive care:cardiovascular medication | Required dosage of adrenaline, noradrenaline, vasopressin or milrinone | through study completion, an average of 24 hours |
| Factors related to the course of operative procedure | time of the intraoperative procedure including the heart-lung-machine | through study completion, up to 24 hours |
| Intra-hospital mortality | Intra-hospital mortality - Safety outcome | through study completion, an average of 7 days |
| Liver failure | Intra-hospital liver failure - Safety outcome | through study completion, an average of 7 days |
| postoperative nausea and vomiting | Detection of postoperative nausea and vomiting | through study completion, up to 24 hours |
| D012893 |
| Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |