Prospective Evaluation of Volatile Sedation After Heart Valve Surgery

January 8, 2024 updated by: Armin N. Flinspach, Goethe University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Frankfurt, Hessen, Germany, 60590
        • University Hospital Frankfurt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to extubation
Time Frame: through study completion, an average of 2 days
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 Frame: through study completion, an average of 2 days
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
Time Frame: through study completion, up to 24 hours
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
Time Frame: through study completion, an average of 24 hours
Measured Postoperative Blood Loss
through study completion, an average of 24 hours
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.
through study completion, an average of 24 hours
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
through study completion, an average of 24 hours
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
through study completion, an average of 24 hours
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
through study completion, an average of 24 hours
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
through study completion, up to 24 hours
Intra-hospital mortality
Time Frame: through study completion, an average of 7 days
Intra-hospital mortality - Safety outcome
through study completion, an average of 7 days
Liver failure
Time Frame: through study completion, an average of 7 days
Intra-hospital liver failure - Safety outcome
through study completion, an average of 7 days
postoperative nausea and vomiting
Time Frame: through study completion, up to 24 hours
Detection of postoperative nausea and vomiting
through study completion, up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Goethe University

Investigators

  • Principal Investigator: Armin N Flinspach, M.D., JWGoethe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Actual)

August 28, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

June 28, 2021

First Submitted That Met QC Criteria

July 1, 2021

First Posted (Actual)

July 12, 2021

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-1050

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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