Anesthesia Depth Increases Delirium Incidence

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: Delirium; Anesthesia Awareness
• Intervention / Treatment: Device: BIS guidance of anesthesia; Other: Standard of Care

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

Study Locations

• Germany
  • Baden-Wuerttemberg
    • Mannheim, Baden-Wuerttemberg, Germany, 68167
      • Clinic of Anesthesiology and Critical Care Medicine, Faculty of Clinical Medicine MAnnheim, University of Heidelberg, Germany

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

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)	Device: BIS guidance of anesthesia; 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	Other: Standard of Care; Anesthesia is administered as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative delirium by NUDESC	in the hospital with NUDESC Score	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	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	1 to 3 days postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality and morbidity	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

• Sponsor: Heidelberg University

Study record dates

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

• Keywords: bispectral index monitoring; anesthesia depth
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Intraoperative Complications; Delirium; Intraoperative Awareness; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• 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