Impact of intraoperative target-controlled EEG sedation monitoring on intraoperative vasopressor support in cardiac surgical patients - an interventional trial

Not Applicable

• Conditions: I25.0; I08.3; Atherosclerotic cardiovascular disease, so described; Combined disorders of mitral, aortic and tricuspid valves

• Registration Number: DRKS00009232
• Lead Sponsor: Klinik für Anästhesiologie und IntensivmedizinUniversitätsklinikum Jena

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-19
• Study Completion: 2016-10-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 239

Inclusion Criteria

planned and elective cardiac surgery with or without CPB
- Age >18 years
- Written informed consent

Exclusion Criteria

- Patient refusal
- Allocation to concurrent interventional trials
- Clinical staff or relatives
- Special operative procedures in hypothermia (i.e. aortic arch operation)
- Conceivable CPB time >3h
- In case of unforeseeable CBP time >3h or massive intraoperative bleeding, patients will be excluded for final study analysis

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the impact of EEG processed neuromonitoring on intraoperative vasopressor support. Primary endpoint: cumulative intraoperative vasopressor application

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints focus on (1) intraopoerative fluid administration, (2) intraoperative awareness, (3) time to extubation after surgery, (4) postoperative confusedness and (5) sleep depth between the study arm and control patients