Back to results

Prospective Evaluation of Volatile Sedation After Heart Valve Surgery

Primary Purpose

Valve Heart Disease, Awakening Early

Status

Recruiting

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Post-operative intensive care using volatile sedation

About this trial

This is an interventional health services research trial for Valve Heart Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University Hospital FrankfurtRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Volatile procedere

Conventional procedere

Arm Description

Intensive care treatment with demand-adapted sedation with volatile anaesthetics

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

Outcomes

Primary Outcome Measures

Time to extubation

Time from admission on ICU until awakening and Extubation.

Secondary Outcome Measures

Time to neurocognitive assessability

Time from admission on ICU until awake and neurocognitive assessable.

Required setup time of the intensive care workplace

Required setup time of the intensive care workplace to provide volatile or intravenous sedation.

Factor related to the course of intensive care: blood loss

Measured Postoperative Blood Loss

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.

Factor related to the course of intensive care: acid-base balance

Measured serum lactate levels and hypercapnia

Factor related to the course of intensive care: lung function parameters

Required inspiratory oxygen fraction

Factor related to the course of intensive care:cardiovascular medication

Required dosage of adrenaline, noradrenaline, vasopressin or milrinone

Factors related to the course of operative procedure

time of the intraoperative procedure including the heart-lung-machine

Intra-hospital mortality

Intra-hospital mortality - Safety outcome

Liver failure

Intra-hospital liver failure - Safety outcome

postoperative nausea and vomiting

Detection of postoperative nausea and vomiting

Full Information

NCT ID

NCT04958668

First Posted

June 28, 2021

Last Updated

August 28, 2023

Sponsor

Goethe University

1. Study Identification

Unique Protocol Identification Number

NCT04958668

Brief Title

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

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 1, 2021 (Actual)

Primary Completion Date

August 28, 2023 (Actual)

Study Completion Date

December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Goethe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Valve Heart Disease, Awakening Early

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Volatile procedere

Arm Type

Active Comparator

Arm Description

Intensive care treatment with demand-adapted sedation with volatile anaesthetics

Arm Title

Conventional procedere

Arm Type

No Intervention

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Post-operative intensive care using volatile sedation

Intervention Description

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..

Primary Outcome Measure Information:

Title

Time to extubation

Description

Time from admission on ICU until awakening and Extubation.

Time Frame

through study completion, an average of 2 days

Secondary Outcome Measure Information:

Title

Time to neurocognitive assessability

Description

Time from admission on ICU until awake and neurocognitive assessable.

Time Frame

through study completion, an average of 2 days

Title

Required setup time of the intensive care workplace

Description

Required setup time of the intensive care workplace to provide volatile or intravenous sedation.

Time Frame

through study completion, up to 24 hours

Title

Factor related to the course of intensive care: blood loss

Description

Measured Postoperative Blood Loss

Time Frame