Anesthesia Depth Increases Delirium Incidence | NCT05656703 | Trialant

Anesthesia Depth Increases Delirium Incidence | NCT05656703 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Contacts/Locations Module

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinic of Anesthesiology and Critical Care Medicine, Faculty of Clinical Medicine MAnnheim, University of Heidelberg, Germany		Mannheim	Baden-Wurttemberg	68167	Germany

Condition Browse Module

Intervention Browse Module