Anesthesia Depth Increases Delirium Incidence

Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05656703
• Other study ID #: 2013-627N-MA
• Status: Completed
• Phase: N/A
• Start date: September 1, 2015
• Est. completion date: March 15, 2021

Study information

• Verified date: December 2022
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: March 15, 2021
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia Awareness
• Delirium
• Intraoperative Awareness

Intervention

Device:
• BIS guidance of anesthesia
Anesthesia is to be directed to a specific (light) level by the dosage of administered hypnotics and analgesics

Other:
• Standard of Care
Anesthesia is administered as usual

Locations

Country	Name	City	State
Germany	Clinic of Anesthesiology and Critical Care Medicine, Faculty of Clinical Medicine MAnnheim, University of Heidelberg, Germany	Mannheim	Baden-Wuerttemberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative delirium by NUDESC	in the hospital with NUDESC Score	6 to 24 months
Primary	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
Primary	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	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