Prospective Evaluation of Volatile Sedation After Heart Valve Surgery

Valve Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04958668
• Other study ID #: 20-1050
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: January 2024
• Source: Goethe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 1, 2023
• Est. primary completion date: August 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Diseases
• Heart Valve Diseases
• Valve Heart Disease

Intervention

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..

Locations

Country	Name	City	State
Germany	University Hospital Frankfurt	Frankfurt	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Goethe University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to extubation	Time from admission on ICU until awakening and Extubation.	through study completion, an average of 2 days
Secondary	Time to neurocognitive assessability	Time from admission on ICU until awake and neurocognitive assessable.	through study completion, an average of 2 days
Secondary	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
Secondary	Factor related to the course of intensive care: blood loss	Measured Postoperative Blood Loss	through study completion, an average of 24 hours
Secondary	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
Secondary	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
Secondary	Factor related to the course of intensive care: lung function parameters	Required inspiratory oxygen fraction	through study completion, an average of 24 hours
Secondary	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
Secondary	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
Secondary	Intra-hospital mortality	Intra-hospital mortality - Safety outcome	through study completion, an average of 7 days
Secondary	Liver failure	Intra-hospital liver failure - Safety outcome	through study completion, an average of 7 days
Secondary	postoperative nausea and vomiting	Detection of postoperative nausea and vomiting	through study completion, up to 24 hours