Anesthesia Awareness, Delirium
Conditions
Keywords
bispectral index monitoring, anesthesia depth
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
Interventions
DEVICEBIS guidance of anesthesia
Anesthesia is to be directed to a specific (light) level by the dosage of administered hypnotics and analgesics
OTHERStandard of Care
Anesthesia is administered as usual
Sponsors
Heidelberg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
group blinding for all of the above except for staff anesthesiologist of the light anesthesia group
Intervention model description
Randomised-controlled, double blind study, monocentric
Eligibility
Sex/Gender
ALL
Age
70 Years to 110 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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)) |
Countries
Germany
Outcome results
None listed