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Clinical Trials/NCT02382445
NCT02382445CompletedNot Applicable

Anesthesia Depth Increases the Degree of Postoperative Dementia, Delirium, and Cognitive Dysfunction by a Higher Load of Neurotrophic Drugs

Heidelberg University1 site in 1 country138 target enrollmentStarted: January 2014Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
138
Locations
1
Primary Endpoint
Postoperative cognition and mental capacity of elderlies following major surgery

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 110 Years (Adult, Older Adult)
Sex
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

Arms & Interventions

Anesthesia depth monitor

Experimental

Anesthesia depth is aimed to be between BIS 50-60

Intervention: Anesthesia depth monitor (Device)

Anesthesia depth monitor

Experimental

Anesthesia depth is aimed to be between BIS 50-60

Intervention: propofol and sevoflurane (Drug)

Control group

Sham Comparator

Anesthesia depth is monitored but blinded to the anesthesiologist

Intervention: Sham control (Device)

Control group

Sham Comparator

Anesthesia depth is monitored but blinded to the anesthesiologist

Intervention: propofol and sevoflurane (Drug)

Outcomes

Primary Outcomes

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 Outcomes

  • Incidence of mental and other complications (serious adverse events)(90 postoperative days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Thomas Frietsch

Prof. Dr. med. Thomas Frietsch

Universitätsmedizin Mannheim

Study Sites (1)

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