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

Goethe University1 site in 1 country100 target enrollmentNovember 1, 2021

ConditionsValve Heart Disease Awakening Early

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Valve Heart Disease
Sponsor: Goethe University
Enrollment: 100
Locations: 1
Primary Endpoint: Time to extubation
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

November 1, 2021

End Date

December 1, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Goethe University

Responsible Party

Principal Investigator

Armin N. Flinspach

Principal Investigator

Goethe University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Time to extubation

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

Time from admission on ICU until awakening and Extubation.

Secondary Outcomes

Factors related to the course of operative procedure(through study completion, up to 24 hours)
Factor related to the course of intensive care: kidney injury(through study completion, an average of 24 hours)
Factor related to the course of intensive care: blood loss(through study completion, an average of 24 hours)
Factor related to the course of intensive care: acid-base balance(through study completion, an average of 24 hours)
Factor related to the course of intensive care: lung function parameters(through study completion, an average of 24 hours)
Factor related to the course of intensive care:cardiovascular medication(through study completion, an average of 24 hours)
Time to neurocognitive assessability(through study completion, an average of 2 days)
Required setup time of the intensive care workplace(through study completion, up to 24 hours)
Intra-hospital mortality(through study completion, an average of 7 days)
Liver failure(through study completion, an average of 7 days)
postoperative nausea and vomiting(through study completion, up to 24 hours)