Prospective Evaluation of Volatile Sedation After Heart Valve Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Evaluation of Volatile Sedation With Regard to Awakening Behaviour and Extubation Capacity in Patients Undergoing Heart Valve Surgery

Conditions
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Valve Heart Disease, Awakening Early

Intervention / Treatment
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* Other: Post-operative intensive care using volatile sedation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Valve reconstruction or valve replacement Must be capable to giving written consent Exclusion Criteria: Intolerance to volatile anaesthetics (e.g. malignant hyperthermia) Severe obstructive pulmonary disease Extended aortic arch or ascending aorta surgery Age <18 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Volatile procedere<br>Intensive care treatment with demand-adapted sedation with volatile anaesthetics | Other: Post-operative intensive care using volatile sedation<br>* 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..<br>|
| No Intervention: Conventional procedere<br>Conventional Intensive care treatment with demand-adapted sedation with intravenous sedatives | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to extubation | Time from admission on ICU until awakening and Extubation. | through study completion, an average of 2 days | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |