Ignite Creation Date:
2024-05-06 @ 6:24 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05656703
Status:
COMPLETED
Last Update Posted:
2022-12-19
First Post:
2022-05-12
Brief Title:
Anesthesia Depth Increases Delirium Incidence
Sponsor:
Heidelberg University
Organization:
Heidelberg University
Study Overview
Official Title:
Monitoring of Anesthesia Depth Reduces the Incidence of Postoperative Delirium and Preserves Memory Abilities Better in the High Risk Elderly
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 n130 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 workingshort term figural workingshort term memories and well as attention level Second aims mortality complications
Patients n130 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 workingshort term figural workingshort term memories and well as attention level Second aims mortality complications
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None