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Anesthesia Depth Increases Delirium Incidence

NCT ID: NCT05656703

Last Updated: 2022-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-01

Study Completion Date

2021-03-15

Brief Summary

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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

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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

Conditions

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Delirium Anesthesia Awareness

Keywords

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bispectral index monitoring anesthesia depth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised-controlled, double blind study, monocentric
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
group blinding for all of the above except for staff anesthesiologist of the light anesthesia group

Study Groups

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Bis Guided light anesthesia

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

Group Type EXPERIMENTAL

BIS guidance of anesthesia

Intervention Type DEVICE

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

Standard of Care

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

Group Type PLACEBO_COMPARATOR

Standard of Care

Intervention Type OTHER

Anesthesia is administered as usual

Interventions

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BIS guidance of anesthesia

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

Intervention Type DEVICE

Standard of Care

Anesthesia is administered as usual

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heidelberg University

OTHER

Sponsor Role lead

Responsible Party

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Thomas Frietsch

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Mannheim, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

Other Identifiers

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2013-627N-MA

Identifier Type: -

Identifier Source: org_study_id