Clinical trial NCT04958668: Prospective Evaluation of Volatile Sedation After Heart Valve Surgery
Official title: Prospective Evaluation of Volatile Sedation With Regard to Awakening Behaviour and Extubation Capacity in Patients Undergoing Heart Valve Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Valve Heart Disease
Awakening Early
Lead sponsor: Goethe University
Sponsor class: OTHER
First posted: 2021-07-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Time to extubation
timeFrame: through study completion, an average of 2 days
Secondary outcomes:
measure: Time to neurocognitive assessability
timeFrame: through study completion, an average of 2 days
measure: Required setup time of the intensive care workplace
timeFrame: through study completion, up to 24 hours
measure: Factor related to the course of intensive care: blood loss
timeFrame: through study completion, an average of 24 hours
measure: Factor related to the course of intensive care: kidney injury
timeFrame: through study completion, an average of 24 hours
measure: Factor related to the course of intensive care: acid-base balance
timeFrame: through study completion, an average of 24 hours
measure: Factor related to the course of intensive care: lung function parameters
timeFrame: through study completion, an average of 24 hours
measure: Factor related to the course of intensive care:cardiovascular medication
timeFrame: through study completion, an average of 24 hours
measure: Factors related to the course of operative procedure
timeFrame: through study completion, up to 24 hours
measure: Intra-hospital mortality
timeFrame: through study completion, an average of 7 days
measure: Liver failure
timeFrame: through study completion, an average of 7 days
measure: postoperative nausea and vomiting
timeFrame: through study completion, up to 24 hours
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: University Hospital Frankfurt
state: Hessen
Study officials:
affiliation: JWGoethe University
name: Armin N Flinspach, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.