NCT05656703

Anesthesia Depth Increases Delirium Incidence

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Heidelberg University · Academic / Other
• Sex: All
• Age: 70 Years – 110 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Delirium
• Anesthesia Awareness

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-09-01
• Primary completion: 2018-06-01
• Completion: 2021-03-15
• First posted: 2022-12-19
• Last updated: 2022-12-19

Locations

1 site across 1 country: Germany