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Completed

NCT Number: NCT04958668

Prospective Evaluation of Volatile Sedation After Heart Valve Surgery

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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Key information

Conditions

Valve Heart Disease Awakening Early Cardiovascular Diseases Dyssomnias Heart Diseases Heart Valve Diseases Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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..

Primary outcomes

  1. Time to extubation

    Time frame: through study completion, an average of 2 days

    Time from admission on ICU until awakening and Extubation.

Secondary outcomes

  1. Time to neurocognitive assessability

    Time frame: through study completion, an average of 2 days

    Time from admission on ICU until awake and neurocognitive assessable.

  2. Required setup time of the intensive care workplace

    Time frame: through study completion, up to 24 hours

    Required setup time of the intensive care workplace to provide volatile or intravenous sedation.

  3. Factor related to the course of intensive care: blood loss

    Time frame: through study completion, an average of 24 hours

    Measured Postoperative Blood Loss

  4. Factor related to the course of intensive care: kidney injury

    Time frame: through study completion, an average of 24 hours

    Measured increases in serum renal retention levels: creatinine and urea in terms of renal failure according to Kidney Disease - Improving Global Outcomes (KDIGO) criteria.

  5. Factor related to the course of intensive care: acid-base balance

    Time frame: through study completion, an average of 24 hours

    Measured serum lactate levels and hypercapnia

  6. Factor related to the course of intensive care: lung function parameters

    Time frame: through study completion, an average of 24 hours

    Required inspiratory oxygen fraction

  7. Factor related to the course of intensive care:cardiovascular medication

    Time frame: through study completion, an average of 24 hours

    Required dosage of adrenaline, noradrenaline, vasopressin or milrinone

  8. Factors related to the course of operative procedure

    Time frame: through study completion, up to 24 hours

    time of the intraoperative procedure including the heart-lung-machine

  9. Intra-hospital mortality

    Time frame: through study completion, an average of 7 days

    Intra-hospital mortality - Safety outcome

  10. Liver failure

    Time frame: through study completion, an average of 7 days

    Intra-hospital liver failure - Safety outcome

  11. postoperative nausea and vomiting

    Time frame: through study completion, up to 24 hours

    Detection of postoperative nausea and vomiting

Sponsors and collaborators

Lead sponsor

Goethe University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 12, 2021
Registry last updated
Jan 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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