Anesthesia Depth Increases Delirium Incidence

NCT05656703 | Completed

• 1 other identifier: 2013-627N-MA
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium; Anesthesia Awareness

Keywords

bispectral index monitoring; anesthesia depth

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• mortality and morbidity

  6 to 24 months

Study Arms (2)

Bis Guided light anesthesia

EXPERIMENTAL

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

Device: BIS guidance of anesthesia

Standard of Care

PLACEBO COMPARATOR

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

Other: Standard of Care

Interventions

BIS guidance of anesthesia DEVICE

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

Bis Guided light anesthesia

Standard of Care OTHER

Anesthesia is administered as usual

Standard of Care

Eligibility Criteria

• Age: 70 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• scheduled for major surgery above 60 min duration
• informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

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

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

MeSH Terms

Conditions

Delirium; Intraoperative Awareness

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: group blinding for all of the above except for staff anesthesiologist of the light anesthesia group
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomised-controlled, double blind study, monocentric

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: December 19, 2022
• Study Start: September 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: March 15, 2021
• Last Updated: December 19, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)