Anesthesia Depth Increases Delirium Incidence

Not Applicable

Completed

• Conditions: Anesthesia Awareness; Delirium

• Registration Number: NCT05656703
• Lead Sponsor: Heidelberg University

Brief Summary

This study aimed to determine whether targeting bispectral index (BIS) readings of 55 (light anaesthesia) was associated with a lower incidence of delirium, dementia (POD), POCD and mortality but higher rates of awareness and complications than a standard of care anaesthesia blinded to depth monitoring.

Detailed Description

Design: Randomised-controlled, double blind study, monocentric Setting: Level 2 medical center, major surgery (non cardiac) Ethics: Ethical approval for this study (Ethikkommission II der Ruprecht-Karls-Universität Heidelberg 2013-627N-MA) was provided by the Ethical Committee II University Medicine Mannheim, University of Heidelberg, Germany (Chairperson Prof W. Striebel) on Mai 12th 2008.

Patients: n=130, aged \> 70y Intervention: Light anesthesia (BIS 55 +/-5) vs. Standard of Care (BIS- blinded) Main outcome measures: Incidence of awareness, delirium, postoperative cognitive deficit (POCD), dementia (POD), memory (MAT with a computerized score for verbal working\&short term, figural working\&short term memories and well as attention level) Second aims: mortality, complications

Study Timeline

• Study Start: 2015-09-01
• Primary Completion: 2018-06-01
• Study Completion: 2021-03-15
• Study First Submitted: 2022-05-12
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-12
• Last Update Submitted: 2022-12-12
• Study First Posted: 2022-12-19
• Last Update Posted: 2022-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• scheduled for major surgery above 60 min duration
• informed consent

Exclusion Criteria

• emergency surgery with large blood loss and/or preoperative cardiovascular instability, scheduled regional or neuraxial anesthesia, language barriers with the unability to understand a German audio tape, unability or unwillingness to consent,hearing disabilities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
awareness, memory function	1 to 3 days postoperative	implicit and explicit memory for intraoperative wakefulness and memory functions in general as changing conditions due to anesthesia
postoperative dementia and cognitive deficit By MMSE and MAT Test	6 to 24 months	in the hospital by MMSE and MAT (automated computerized test), after discharge by a standardized questionnaire
postoperative delirium by NUDESC	6 to 24 months	in the hospital with NUDESC Score

Secondary Outcome Measures

Name	Time	Method
mortality and morbidity	6 to 24 months	death rate (in hospital and longterm mortality (death/month)) and complication rate (in hospital and longterm morbidity (complications/month))

Trial Locations

Locations (1)

Clinic of Anesthesiology and Critical Care Medicine, Faculty of Clinical Medicine MAnnheim, University of Heidelberg, Germany; 🇩🇪 Mannheim, Baden-Wuerttemberg, Germany