An interventional study of BIS guidance of anesthesia and Standard of Care in Delirium and Anesthesia Awareness, sponsored by Heidelberg University. Completed at 1 site in Germany. Open to participants aged 70 Years to 110 Years. Per ClinicalTrials.gov, last updated 2022-12-19.
Sponsored by Heidelberg University · Not applicable, Interventional, and Prevention
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.
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
1,071 studies on the registry are indexed under Delirium; 239 are open to participants now.
This study's enrollment of 130 is close to the median of 119 across 608 interventional studies indexed under Delirium.
Browse Delirium studies →Heidelberg University is the lead sponsor of 287 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
Patients are monitored by bispectral index and held under light anesthesia (BIS level 45 to 60)
Device: BIS guidance of anesthesia
Patients receive standard of care anesthesia, BIS monitor was covered with a blind
Other: Standard of Care
Anesthesia is to be directed to a specific (light) level by the dosage of administered hypnotics and analgesics
Anesthesia is administered as usual
postoperative delirium by NUDESC
in the hospital with NUDESC Score
Time frame: 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
Time frame: 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
Time frame: 1 to 3 days postoperative
mortality and morbidity
death rate (in hospital and longterm mortality (death/month)) and complication rate (in hospital and longterm morbidity (complications/month))
Time frame: 6 to 24 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2015 to primary completion in Jun 2018, 33 months.
Of 248 non-industry interventional studies with no phase under Delirium, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 45. This study's 33 months is above that.
Counting every sponsor, half of 250 studies reached it within 27 months; a quarter within 12 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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