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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
Sponsor:
Information provided by (Responsible Party):
Thomas Frietsch, Universitätsmedizin Mannheim

Brief Summary:

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
Anesthesia Delirium Dementia Bispectral Index Monitor Device: Anesthesia depth monitor Device: Sham control Drug: propofol and sevoflurane Not Applicable

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium Dementia

Arm Intervention/treatment
Experimental: Anesthesia depth monitor
Anesthesia depth is aimed to be between BIS 50-60
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
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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
Criteria

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

Information from the National Library of Medicine

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


Locations
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Germany
Diakonissen Hospital
Mannheim, BW, Germany, 69163
Sponsors and Collaborators
Heidelberg University
Investigators
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Study Director: Thomas Frietsch, Prof, MD Universitätsmedizin Mannheim
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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
Additional relevant MeSH terms:
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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