Prospective Evaluation of Volatile Sedation After Heart Valve Surgery

Not Applicable

Completed

• Conditions: Valve Heart Disease; Awakening Early
• Interventions: Other: Post-operative intensive care using volatile sedation

• Registration Number: NCT04958668
• Lead Sponsor: Goethe University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-28
• Study First Submitted QC: 2021-07-01
• Study First Posted: 2021-07-12
• Study Start: 2021-11-01
• Primary Completion: 2023-08-28
• Study Completion: 2023-12-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Volatile procedere	Post-operative intensive care using volatile sedation	Intensive care treatment with demand-adapted sedation with volatile anaesthetics

Primary Outcome Measures

Name	Time	Method
Time to extubation	through study completion, an average of 2 days	Time from admission on ICU until awakening and Extubation.

Secondary Outcome Measures

Name	Time	Method
Factors related to the course of operative procedure	through study completion, up to 24 hours	time of the intraoperative procedure including the heart-lung-machine
Factor related to the course of intensive care: kidney injury	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.
Factor related to the course of intensive care: blood loss	through study completion, an average of 24 hours	Measured Postoperative Blood Loss
Factor related to the course of intensive care: acid-base balance	through study completion, an average of 24 hours	Measured serum lactate levels and hypercapnia
Factor related to the course of intensive care: lung function parameters	through study completion, an average of 24 hours	Required inspiratory oxygen fraction
Factor related to the course of intensive care:cardiovascular medication	through study completion, an average of 24 hours	Required dosage of adrenaline, noradrenaline, vasopressin or milrinone
Time to neurocognitive assessability	through study completion, an average of 2 days	Time from admission on ICU until awake and neurocognitive assessable.
Required setup time of the intensive care workplace	through study completion, up to 24 hours	Required setup time of the intensive care workplace to provide volatile or intravenous sedation.
Intra-hospital mortality	through study completion, an average of 7 days	Intra-hospital mortality - Safety outcome
Liver failure	through study completion, an average of 7 days	Intra-hospital liver failure - Safety outcome
postoperative nausea and vomiting	through study completion, up to 24 hours	Detection of postoperative nausea and vomiting

Trial Locations

Locations (1)

University Hospital Frankfurt; 🇩🇪 Frankfurt, Hessen, Germany