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Anesthesia Depth Increases the Degree of Postoperative Dementia, Delirium, and Cognitive Dysfunction (BIS & Dementia)

Primary Purpose

Anesthesia, Delirium, Dementia

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Anesthesia depth monitor
Sham control
propofol and sevoflurane
Sponsored by
Heidelberg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia

Eligibility Criteria

18 Years - 110 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Diakonissen Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Anesthesia depth monitor

Control group

Arm Description

Anesthesia depth is aimed to be between BIS 50-60

Anesthesia depth is monitored but blinded to the anesthesiologist

Outcomes

Primary Outcome Measures

Postoperative cognition and mental capacity of elderlies following major 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

Incidence of mental and other complications (serious adverse events)
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.

Full Information

First Posted
August 11, 2014
Last Updated
May 17, 2022
Sponsor
Heidelberg University
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1. Study Identification

Unique Protocol Identification Number
NCT02382445
Brief Title
Anesthesia Depth Increases the Degree of Postoperative Dementia, Delirium, and Cognitive Dysfunction
Acronym
BIS & Dementia
Official Title
Anesthesia Depth Increases the Degree of Postoperative Dementia, Delirium, and Cognitive Dysfunction by a Higher Load of Neurotrophic Drugs
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
May 8, 2017 (Actual)
Study Completion Date
May 8, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heidelberg University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Delirium, Dementia, Bispectral Index Monitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anesthesia depth monitor
Arm Type
Experimental
Arm Description
Anesthesia depth is aimed to be between BIS 50-60
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Anesthesia depth is monitored but blinded to the anesthesiologist
Intervention Type
Device
Intervention Name(s)
Anesthesia depth monitor
Other Intervention Name(s)
Aim at an anesthesia level of BIS 50-60 titrating propofol and sevoflurane in the experimental
Intervention Type
Device
Intervention Name(s)
Sham control
Intervention Description
Standard care as usual. Bis m Standard care as usual. Bispectral index monitor is not visible for anesthesia provider.
Intervention Type
Drug
Intervention Name(s)
propofol and sevoflurane
Primary Outcome Measure Information:
Title
Postoperative cognition and mental capacity of elderlies following major surgery
Description
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.
Time Frame
One day after surgery
Secondary Outcome Measure Information:
Title
Incidence of mental and other complications (serious adverse events)
Description
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.
Time Frame
90 postoperative days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Frietsch, Prof, MD
Organizational Affiliation
Universitätsmedizin Mannheim
Official's Role
Study Director
Facility Information:
Facility Name
Diakonissen Hospital
City
Mannheim
State/Province
BW
ZIP/Postal Code
69163
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Anesthesia Depth Increases the Degree of Postoperative Dementia, Delirium, and Cognitive Dysfunction

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