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Anesthesia Depth Increases Delirium Incidence

Primary Purpose

Delirium, Anesthesia Awareness

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
BIS guidance of anesthesia
Standard of Care
Sponsored by
Heidelberg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Delirium focused on measuring bispectral index monitoring, anesthesia depth

Eligibility Criteria

70 Years - 110 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bis Guided light anesthesia

Standard of Care

Arm Description

Patients are monitored by bispectral index and held under light anesthesia (BIS level 45 to 60)

Patients receive standard of care anesthesia, BIS monitor was covered with a blind

Outcomes

Primary Outcome Measures

postoperative delirium by NUDESC
in the hospital with NUDESC Score
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
awareness, memory function
implicit and explicit memory for intraoperative wakefulness and memory functions in general as changing conditions due to anesthesia

Secondary Outcome Measures

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

Full Information

First Posted
May 12, 2022
Last Updated
December 12, 2022
Sponsor
Heidelberg University
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1. Study Identification

Unique Protocol Identification Number
NCT05656703
Brief Title
Anesthesia Depth Increases Delirium Incidence
Official Title
Monitoring of Anesthesia Depth Reduces the Incidence of Postoperative Delirium and Preserves Memory Abilities Better in the High Risk Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2015 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
March 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heidelberg University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium, Anesthesia Awareness
Keywords
bispectral index monitoring, anesthesia depth

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised-controlled, double blind study, monocentric
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
group blinding for all of the above except for staff anesthesiologist of the light anesthesia group
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bis Guided light anesthesia
Arm Type
Experimental
Arm Description
Patients are monitored by bispectral index and held under light anesthesia (BIS level 45 to 60)
Arm Title
Standard of Care
Arm Type
Placebo Comparator
Arm Description
Patients receive standard of care anesthesia, BIS monitor was covered with a blind
Intervention Type
Device
Intervention Name(s)
BIS guidance of anesthesia
Intervention Description
Anesthesia is to be directed to a specific (light) level by the dosage of administered hypnotics and analgesics
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Anesthesia is administered as usual
Primary Outcome Measure Information:
Title
postoperative delirium by NUDESC
Description
in the hospital with NUDESC Score
Time Frame
6 to 24 months
Title
postoperative dementia and cognitive deficit By MMSE and MAT Test
Description
in the hospital by MMSE and MAT (automated computerized test), after discharge by a standardized questionnaire
Time Frame
6 to 24 months
Title
awareness, memory function
Description
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 Outcome Measure Information:
Title
mortality and morbidity
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Clinic of Anesthesiology and Critical Care Medicine, Faculty of Clinical Medicine MAnnheim, University of Heidelberg, Germany
City
Mannheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
68167
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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Anesthesia Depth Increases Delirium Incidence

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