Anesthesia Depth Increases the Degree of Postoperative Dementia, Delirium, and Cognitive Dysfunction (BIS & Dementia)
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ClinicalTrials.gov Identifier: NCT02382445 |
Recruitment Status :
Completed
First Posted : March 6, 2015
Last Update Posted : May 24, 2022
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Anesthetics and anesthesia are suspicious to induce dementia or aggravate preexistent cognitive deficits with or without evoking postoperative delirium. In animal trials various anesthetics induce increased levels of misfolded amyloid beta and protein tau, the molecular substance of pathophysiologic brain tissues of demented patients. The amount of those markers seems to correlate well with the degree of dementia [1]. In contradiction, a single study indicates that the incidence of postoperative cognitive deficit (POCD) decreases if hypnotic depth is deep [2]. Unfortunately the study did not sum up the amount of anesthetic drug load, since this would have clarified if the amount of anesthetics used is associated to POCD and dementia. Another possibility is that stress and noxious stimulation induced by light anesthesia results in POCD, whereas deep anesthesia protects from it or inhibits implicit memory.
The investigators' prospective randomized trial is underway to verify the impact of anesthetics and narcotic depth upon grade of dementia and incidence of early postoperative cognitive dysfunction on postoperative day 1 as well as the incidence of delirium within a 90 day period.
The investigators' hypothesis is that the incidence of POCD and delirium and the degree of early cognitive dysfunction is less when anesthetic and vasoactive drug load is less in the BIS- guided anesthesia group with the superficial but sufficient anesthesia level.
Condition or disease | Intervention/treatment | Phase |
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Anesthesia Delirium Dementia Bispectral Index Monitor | Device: Anesthesia depth monitor Device: Sham control Drug: propofol and sevoflurane | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 138 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Anesthesia Depth Increases the Degree of Postoperative Dementia, Delirium, and Cognitive Dysfunction by a Higher Load of Neurotrophic Drugs |
Study Start Date : | January 2014 |
Actual Primary Completion Date : | May 8, 2017 |
Actual Study Completion Date : | May 8, 2017 |

Arm | Intervention/treatment |
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Experimental: Anesthesia depth monitor
Anesthesia depth is aimed to be between BIS 50-60
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Device: Anesthesia depth monitor
Other Name: Aim at an anesthesia level of BIS 50-60 titrating propofol and sevoflurane in the experimental Drug: propofol and sevoflurane |
Sham Comparator: Control group
Anesthesia depth is monitored but blinded to the anesthesiologist
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Device: Sham control
Standard care as usual. Bis m Standard care as usual. Bispectral index monitor is not visible for anesthesia provider. Drug: propofol and sevoflurane |
- Postoperative cognition and mental capacity of elderlies following major surgery [ Time Frame: One day after surgery ]Mini Mental State Test (MMSE) and automated Memory and Attention Test (MAT) were performed on the day before and after the surgery. The MAT is a validated computerized test for the discrimination of short and long time memory, for visual and auditory comprehension and attention capacity.
- Incidence of mental and other complications (serious adverse events) [ Time Frame: 90 postoperative days ]Incidences of delirium and mental dysfunction until hospital discharge is counted. Delirium was postoperatively diagnosed by the NUDESC, postoperative cognitive dysfunction (POCD) by the MAT, other serious adverse events in the course of the hospital stay were noted.

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Ages Eligible for Study: | 18 Years to 110 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- adults older than 70 years
- major surgery ( spine, orthopedic, urologic, gynecology, abdominal)
Exclusion Criteria:
- adults younger than 71 years
- major blood loss surgery
- allergy to soja oil, nuts, other ingredients of propofol
- patient wants to have spinal or regional anesthesia only

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02382445
Germany | |
Diakonissen Hospital | |
Mannheim, BW, Germany, 69163 |
Study Director: | Thomas Frietsch, Prof, MD | Universitätsmedizin Mannheim |
Responsible Party: | Thomas Frietsch, Prof. Dr. med. Thomas Frietsch, Universitätsmedizin Mannheim |
ClinicalTrials.gov Identifier: | NCT02382445 |
Other Study ID Numbers: |
BIS-Diako-Ma-2014 |
First Posted: | March 6, 2015 Key Record Dates |
Last Update Posted: | May 24, 2022 |
Last Verified: | May 2022 |
Dementia Delirium Cognitive Dysfunction Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurocognitive Disorders Mental Disorders Confusion Neurobehavioral Manifestations Neurologic Manifestations |
Cognition Disorders Anesthetics Propofol Sevoflurane Central Nervous System Depressants Physiological Effects of Drugs Hypnotics and Sedatives Anesthetics, Intravenous Anesthetics, General Platelet Aggregation Inhibitors Anesthetics, Inhalation |