Anesthesia Depth Increases Delirium Incidence
December 12, 2022 updated by: Thomas Frietsch, Heidelberg University
Monitoring of Anesthesia Depth Reduces the Incidence of Postoperative Delirium and Preserves Memory Abilities Better in the High Risk Elderly
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
130
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Baden-Wuerttemberg
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Mannheim, Baden-Wuerttemberg, Germany, 68167
- Clinic of Anesthesiology and Critical Care Medicine, Faculty of Clinical Medicine MAnnheim, University of Heidelberg, Germany
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
66 years to 106 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Bis Guided light anesthesia
Patients are monitored by bispectral index and held under light anesthesia (BIS level 45 to 60)
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Anesthesia is to be directed to a specific (light) level by the dosage of administered hypnotics and analgesics
|
|
Placebo Comparator: Standard of Care
Patients receive standard of care anesthesia, BIS monitor was covered with a blind
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Anesthesia is administered as usual
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
postoperative delirium by NUDESC
Time Frame: 6 to 24 months
|
in the hospital with NUDESC Score
|
6 to 24 months
|
|
postoperative dementia and cognitive deficit By MMSE and MAT Test
Time Frame: 6 to 24 months
|
in the hospital by MMSE and MAT (automated computerized test), after discharge by a standardized questionnaire
|
6 to 24 months
|
|
awareness, memory function
Time Frame: 1 to 3 days postoperative
|
implicit and explicit memory for intraoperative wakefulness and memory functions in general as changing conditions due to anesthesia
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1 to 3 days postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
mortality and morbidity
Time Frame: 6 to 24 months
|
death rate (in hospital and longterm mortality (death/month)) and complication rate (in hospital and longterm morbidity (complications/month))
|
6 to 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2015
Primary Completion (Actual)
June 1, 2018
Study Completion (Actual)
March 15, 2021
Study Registration Dates
First Submitted
May 12, 2022
First Submitted That Met QC Criteria
December 12, 2022
First Posted (Actual)
December 19, 2022
Study Record Updates
Last Update Posted (Actual)
December 19, 2022
Last Update Submitted That Met QC Criteria
December 12, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-627N-MA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.