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Completed

NCT Number: NCT05656703

Anesthesia Depth Increases Delirium Incidence

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.

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Key information

Conditions

Delirium Anesthesia Awareness Confusion Intraoperative Awareness Intraoperative Complications Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

70 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Mannheim, Baden-Wurttemberg, 68167, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BIS guidance of anesthesia

Device

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

Standard of care

Other

Anesthesia is administered as usual

Primary outcomes

  1. postoperative delirium by NUDESC

    Time frame: 6 to 24 months

    in the hospital with NUDESC Score

  2. 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

  3. 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

Secondary outcomes

  1. 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))

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Registry information

Official study title

Monitoring of Anesthesia Depth Reduces the Incidence of Postoperative Delirium and Preserves Memory Abilities Better in the High Risk Elderly

Important dates

Study start
2015
Primary completion
2018
Study completion
2021
First posted
Dec 19, 2022
Registry last updated
Dec 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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