Anesthesia Depth Increases Delirium Incidence

Heidelberg University

Status: Completed

Conditions: Delirium; Anesthesia Awareness

Treatments: Device: BIS guidance of anesthesia; Other: Standard of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT05656703

2013-627N-MA

Details and patient eligibility

About

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.

Full 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

Enrollment: 130 patients

Sex: All

Ages: 70 to 110 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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130 participants in 2 patient groups, including a placebo group

Bis Guided light anesthesia

Experimental group

Description:

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

Treatment:

Device: BIS guidance of anesthesia

Standard of Care

Placebo Comparator group

Description:

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

Treatment:

Other: Standard of Care