Anesthesia Depth Increases Delirium Incidence

Not Applicable

Completed

• Conditions: Anesthesia Awareness; Delirium
• Interventions: Device: BIS guidance of anesthesia; Other: Standard of Care

• 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

Arm && Interventions

Group	Intervention	Description
Bis Guided light anesthesia	BIS guidance of anesthesia	Patients are monitored by bispectral index and held under light anesthesia (BIS level 45 to 60)
Standard of Care	Standard of Care	Patients receive standard of care anesthesia, BIS monitor was covered with a blind

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