Anesthesia Depth Increases Delirium Incidence

Heidelberg University130 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

130

Conditions

Delirium Anesthesia Awareness

Interventions

BIS guidance of anesthesiaDEVICE

Anesthesia is to be directed to a specific (light) level by the dosage of administered hypnotics and analgesics

Standard of CareOTHER

Anesthesia is administered as usual

Eligibility

Sex: ALLMin age: 70 YearsMax age: 110 Years

Medical Language ↔ Plain English

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

Locations (1)

Clinic of Anesthesiology and Critical Care Medicine, Faculty of Clinical Medicine MAnnheim, University of Heidelberg, Germany

Mannheim, Baden-Wurttemberg, Germany

Outcomes

Primary Outcomes

postoperative delirium by NUDESC

in the hospital with NUDESC Score

Time frame: 6 to 24 months

postoperative dementia and cognitive deficit By MMSE and MAT Test

in the hospital by MMSE and MAT (automated computerized test), after discharge by a standardized questionnaire

Time frame: 6 to 24 months

awareness, memory function

implicit and explicit memory for intraoperative wakefulness and memory functions in general as changing conditions due to anesthesia

Time frame: 1 to 3 days postoperative

Secondary Outcomes

mortality and morbidity

death rate (in hospital and longterm mortality (death/month)) and complication rate (in hospital and longterm morbidity (complications/month))

Time frame: 6 to 24 months

Data from ClinicalTrials.gov

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