Prospective Evaluation of Volatile Sedation After Heart Valve Surgery

Goethe University

Status: Completed

Conditions: Awakening Early; Valve Heart Disease

Treatments: Other: Post-operative intensive care using volatile sedation

Study type: Interventional

Funder types: Other

Identifiers

NCT04958668

20-1050

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Volatile procedere

Active Comparator group

Description:

Intensive care treatment with demand-adapted sedation with volatile anaesthetics

Treatment:

Other: Post-operative intensive care using volatile sedation

Conventional procedere

No Intervention group

Description:

Conventional Intensive care treatment with demand-adapted sedation with intravenous sedatives