Prospective Evaluation of Volatile Sedation After Heart Valve Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2023-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Volatile Anesthetics to Reduce Mortality in Cardiac Surgery

NCT02105610

Aortocoronary Bypass Cardiac Surgery Coronary Artery Bypass Grafting

COMPLETED PHASE4

Delirium Reduction by Volatile Anesthesia in Cardiac Surgery

NCT03729011

Delirium

COMPLETED PHASE4

Organ Protection With Sevoflurane Postconditioning After Cardiac Surgery With Cardiopulmonary Bypass

NCT00924222

Cardiac On-pump Surgery

COMPLETED NA

Comparison Between Propofol and Inhalational Anaesthetic Agents on Cardiovascular Outcomes Following Cardiac Surgery

NCT04039854

Coronary Heart Disease Cardiovascular Diseases

UNKNOWN PHASE4

Influence of Anesthetics on Clinical Outcome in Mitral and Aortic Valve Replacement in Adults

NCT05696509

Mitral Valve Insufficiency Aortic Valve Insufficiency

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Valve Heart Disease Awakening Early

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Volatile procedere

Intensive care treatment with demand-adapted sedation with volatile anaesthetics

Group Type ACTIVE_COMPARATOR

Post-operative intensive care using volatile sedation

Intervention Type OTHER

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..

Conventional procedere

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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..

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No